Colon and Rectal

SAN DIEGO – Clear resection margins, no matter how narrow, are associated with increased survival when surgeons excise liver tumors from metastatic colorectal cancer (MCRC).

When colorectal cancer metastasizes to the liver, tumor resection can be a safe intervention that improves long-term survival and contributes to cure. Previous studies have shown that any amount of negative margin had a positive impact on overall survival, but these smaller studies were hampered by lack of uniformity in definitions and in surgical technique. Additionally, new developments in chemotherapy have changed the treatment course and overall survival for those with MCRC and need to be taken into account.

©Eraxion/thinkstockphotos.com

Dr. Michael D’Angelica and his colleagues at Memorial Sloan Kettering Cancer Center, New York, presented findings from a large, single-center cohort of patients with MCRC at the annual meeting of the American Surgical Association. The aims of the study, he said, were to analyze the association between margin width of tumor resection and survival in an updated cohort receiving modern therapies, and to account for potentially confounding factors.

The study included 2,368 patients who had hepatic resection for MCRC from 1992 to 2012; patients had the same liver transection method and had high-resolution microscopic pathologic measurement of tumor margins, which allowed submillimeter assessment of margin width. Dr. D’Angelica said that the study captured clinical and patient characteristics, including the number and size of tumors, clinical risk scores, and the presence of any extrahepatic disease.

About half of all patients (n = 1,191) had tumor margins between 1 and 9 mm; one-third (n = 765) had tumor margins of 10 mm or more. One in 10 patients (n = 245) had positive tumor margins, while the remaining 7% (n = 160) had negative tumor margins of 0.9 mm or less.

The study cohort was followed for a median 55 months; a significant relationship between margin width and survival emerged, with all negative margins widths being associated with significantly longer overall survival than the survival curve for those with positive margins (P < .01). This was true even for the narrowest margin widths. Factors associated with submillimeter tumor margins included tumor ablation, having more than three tumors, or tumor size over 5 cm.

Survival differences seen with submillimeter differences in tumor margin are likely attributable to currently unknown tumor growth properties, rather than actual margin width, Dr. D’Angelica said. In response to a question from Dr. Jean-Nicolas Vauthey of MD Anderson Cancer Center, Houston, Dr. D’Angelica speculated that the future of treating MCRC may rely on microscopic determination of tumor growth patterns, as well as better understanding of underlying gene patterns.

“Negative histologic margins, at all widths, including submillimeter margins, are independently associated with improved overall survival,” said Dr. D’Angelica. A significant difference was seen between patients with positive margins and any negative margin width, and between patients with submillimeter vs. 1 mm or greater margins. Beyond 1 mm, however, increasing margins widths were not associated with increased survival benefit.

Dr. D’Angelica noted that surgeons should not fear that a surgery with anticipated close margins would not benefit the patient, since any amount of clear margin confers a survival benefit. Wide margins, however, should be attempted when the approach is safe and feasible because it is the best-known technical approach to ensure a negative tumor margin. Very narrow margins, he noted, are probably a marker for an unknown biological factor rather than a true reflection of surgical technique.

The authors reported no disclosures.

The complete manuscript of this study and its presentation at the American Surgical Association’s 135th Annual Meeting, April 2015, in San Diego, California, are anticipated to be published in the Annals of Surgery pending editorial review.

SAN DIEGO – Clear resection margins, no matter how narrow, are associated with increased survival when surgeons excise liver tumors from metastatic colorectal cancer (MCRC).

When colorectal cancer metastasizes to the liver, tumor resection can be a safe intervention that improves long-term survival and contributes to cure. Previous studies have shown that any amount of negative margin had a positive impact on overall survival, but these smaller studies were hampered by lack of uniformity in definitions and in surgical technique. Additionally, new developments in chemotherapy have changed the treatment course and overall survival for those with MCRC and need to be taken into account.

©Eraxion/thinkstockphotos.com

Dr. Michael D’Angelica and his colleagues at Memorial Sloan Kettering Cancer Center, New York, presented findings from a large, single-center cohort of patients with MCRC at the annual meeting of the American Surgical Association. The aims of the study, he said, were to analyze the association between margin width of tumor resection and survival in an updated cohort receiving modern therapies, and to account for potentially confounding factors.

The study included 2,368 patients who had hepatic resection for MCRC from 1992 to 2012; patients had the same liver transection method and had high-resolution microscopic pathologic measurement of tumor margins, which allowed submillimeter assessment of margin width. Dr. D’Angelica said that the study captured clinical and patient characteristics, including the number and size of tumors, clinical risk scores, and the presence of any extrahepatic disease.

About half of all patients (n = 1,191) had tumor margins between 1 and 9 mm; one-third (n = 765) had tumor margins of 10 mm or more. One in 10 patients (n = 245) had positive tumor margins, while the remaining 7% (n = 160) had negative tumor margins of 0.9 mm or less.

The study cohort was followed for a median 55 months; a significant relationship between margin width and survival emerged, with all negative margins widths being associated with significantly longer overall survival than the survival curve for those with positive margins (P < .01). This was true even for the narrowest margin widths. Factors associated with submillimeter tumor margins included tumor ablation, having more than three tumors, or tumor size over 5 cm.

Survival differences seen with submillimeter differences in tumor margin are likely attributable to currently unknown tumor growth properties, rather than actual margin width, Dr. D’Angelica said. In response to a question from Dr. Jean-Nicolas Vauthey of MD Anderson Cancer Center, Houston, Dr. D’Angelica speculated that the future of treating MCRC may rely on microscopic determination of tumor growth patterns, as well as better understanding of underlying gene patterns.

“Negative histologic margins, at all widths, including submillimeter margins, are independently associated with improved overall survival,” said Dr. D’Angelica. A significant difference was seen between patients with positive margins and any negative margin width, and between patients with submillimeter vs. 1 mm or greater margins. Beyond 1 mm, however, increasing margins widths were not associated with increased survival benefit.

Dr. D’Angelica noted that surgeons should not fear that a surgery with anticipated close margins would not benefit the patient, since any amount of clear margin confers a survival benefit. Wide margins, however, should be attempted when the approach is safe and feasible because it is the best-known technical approach to ensure a negative tumor margin. Very narrow margins, he noted, are probably a marker for an unknown biological factor rather than a true reflection of surgical technique.

The authors reported no disclosures.

The complete manuscript of this study and its presentation at the American Surgical Association’s 135th Annual Meeting, April 2015, in San Diego, California, are anticipated to be published in the Annals of Surgery pending editorial review.

SAN DIEGO – Clear resection margins, no matter how narrow, are associated with increased survival when surgeons excise liver tumors from metastatic colorectal cancer (MCRC).

When colorectal cancer metastasizes to the liver, tumor resection can be a safe intervention that improves long-term survival and contributes to cure. Previous studies have shown that any amount of negative margin had a positive impact on overall survival, but these smaller studies were hampered by lack of uniformity in definitions and in surgical technique. Additionally, new developments in chemotherapy have changed the treatment course and overall survival for those with MCRC and need to be taken into account.

©Eraxion/thinkstockphotos.com

Dr. Michael D’Angelica and his colleagues at Memorial Sloan Kettering Cancer Center, New York, presented findings from a large, single-center cohort of patients with MCRC at the annual meeting of the American Surgical Association. The aims of the study, he said, were to analyze the association between margin width of tumor resection and survival in an updated cohort receiving modern therapies, and to account for potentially confounding factors.

The study included 2,368 patients who had hepatic resection for MCRC from 1992 to 2012; patients had the same liver transection method and had high-resolution microscopic pathologic measurement of tumor margins, which allowed submillimeter assessment of margin width. Dr. D’Angelica said that the study captured clinical and patient characteristics, including the number and size of tumors, clinical risk scores, and the presence of any extrahepatic disease.

About half of all patients (n = 1,191) had tumor margins between 1 and 9 mm; one-third (n = 765) had tumor margins of 10 mm or more. One in 10 patients (n = 245) had positive tumor margins, while the remaining 7% (n = 160) had negative tumor margins of 0.9 mm or less.

The study cohort was followed for a median 55 months; a significant relationship between margin width and survival emerged, with all negative margins widths being associated with significantly longer overall survival than the survival curve for those with positive margins (P < .01). This was true even for the narrowest margin widths. Factors associated with submillimeter tumor margins included tumor ablation, having more than three tumors, or tumor size over 5 cm.

Survival differences seen with submillimeter differences in tumor margin are likely attributable to currently unknown tumor growth properties, rather than actual margin width, Dr. D’Angelica said. In response to a question from Dr. Jean-Nicolas Vauthey of MD Anderson Cancer Center, Houston, Dr. D’Angelica speculated that the future of treating MCRC may rely on microscopic determination of tumor growth patterns, as well as better understanding of underlying gene patterns.

“Negative histologic margins, at all widths, including submillimeter margins, are independently associated with improved overall survival,” said Dr. D’Angelica. A significant difference was seen between patients with positive margins and any negative margin width, and between patients with submillimeter vs. 1 mm or greater margins. Beyond 1 mm, however, increasing margins widths were not associated with increased survival benefit.

Dr. D’Angelica noted that surgeons should not fear that a surgery with anticipated close margins would not benefit the patient, since any amount of clear margin confers a survival benefit. Wide margins, however, should be attempted when the approach is safe and feasible because it is the best-known technical approach to ensure a negative tumor margin. Very narrow margins, he noted, are probably a marker for an unknown biological factor rather than a true reflection of surgical technique.

The authors reported no disclosures.

The complete manuscript of this study and its presentation at the American Surgical Association’s 135th Annual Meeting, April 2015, in San Diego, California, are anticipated to be published in the Annals of Surgery pending editorial review.

SAN DIEGO – A combination of bowel cleansing and oral antibiotics nearly halved the risk of common and troublesome complications in colorectal surgery. Infections, leaks, and postsurgical ileus were all significantly less likely with the combined regime, according to a study reported at the annual meeting of the American Surgical Association.

Patients preparing for colorectal surgery routinely received mechanical bowel preparation in combination with oral antibiotics in the 1970s. However, since then, the availability of IV antibiotics combined with concerns about complications from bowel preparation have contributed to a decline in use of the regime. Consensus is lacking about best practices for preparation for colorectal surgery.

Dr. P. Ravi Kiran, chief and program director of Columbia University Medical Center’s division of colorectal surgery, presented findings from a large retrospective study that addressed whether oral antibiotics and mechanical bowel preparation reduced the risk of complications from colorectal surgery. Drawing from targeted colectomy data, available from 2012 onward through the large American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database, Dr. Kiran and associates compared three groups of patients undergoing elective colectomy. Of the total 8,644 patients, 2,498 (28.9%) received no preparation, 3,822 (44.2%) received mechanical bowel preparation alone, and 2,324 (26.9%) received both oral antibiotics and mechanical bowel preparation.

Primary outcome measures included the presence of anastomotic leak from the surgery, surgical site infections, ileus, and all-cause mortality. The patients were well matched by age and gender, and surgery type; case complexity and degree of resident physician involvement in the surgical procedures were also similar between arms.

On multivariable analysis, patients who received mechanical bowel preparation and oral antibiotics were significantly less likely to have surgical site infections (odds ratio, 0.43), to sustain ileus (OR, 0.71), or to have anastomotic leak (OR, 0.56). Postoperatively, those who had received no bowel preparation were also significantly more likely to have pneumonia, to require reintubation, and to fail to wean from the ventilator. They also were more likely to have deep vein thrombosis and sepsis. All-cause 30-day mortality was also significantly less likely in the group receiving both bowel preparation and oral antibiotics.

Dr. Kiran noted that investigators were not able to determine the type of mechanical bowel preparation patients received, and likely could not control for all confounders.

Discussant Dr. Heidi Nelson of the Mayo Clinic, Rochester, Minn., noted that despite the study’s strengths, including its large size and the real-world nature of the investigation, she doubts that the study will be considered definitive. Limitations that critics might point out, she noted, are the retrospective nature of the study and the possibility that the three groups studied were not really comparable because of subtle selection biases on the part of the treating surgeons. Dr. Kiran conceded that though multivariable analysis attempted to account and control for as many between-group differences as they could identify, differences probably did persist.

Dr. Hiram Polk of the University of Louisville (Ky.) commented that studies such as these using massive databases, though they may show what is true, may not always point to what is clinically relevant. Overall, it’s been shown that about one in four patients given systemic antibiotics are given the wrong drug, he said; further, “the only place you can truly sterilize a colon is in an autoclave.” Dr. Kiran did note that the combined oral preparation regime was successful in reducing the incidence of the most common complications by about 50%.

Following with more real-world observations, Dr. Mary Otterson of the Medical College of Wisconsin, Milwaukee, commented that the effective dose of preoperative erythromycin is very close to doses that cause significant nausea and vomiting. In her experience, “If we went any higher, they vomited. We also had unplanned admits with electrolyte abnormalities.” The best-tolerated and most effective regime, she said, should be identified by a prospective, randomized, controlled trial.

The authors reported no conflicts of interest.

The complete manuscript of this study and its presentation at the American Surgical Association’s 135th Annual Meeting, April 2015, in San Diego, California, are anticipated to be published in the Annals of Surgery pending editorial review.

SAN DIEGO – A combination of bowel cleansing and oral antibiotics nearly halved the risk of common and troublesome complications in colorectal surgery. Infections, leaks, and postsurgical ileus were all significantly less likely with the combined regime, according to a study reported at the annual meeting of the American Surgical Association.

Patients preparing for colorectal surgery routinely received mechanical bowel preparation in combination with oral antibiotics in the 1970s. However, since then, the availability of IV antibiotics combined with concerns about complications from bowel preparation have contributed to a decline in use of the regime. Consensus is lacking about best practices for preparation for colorectal surgery.

Dr. P. Ravi Kiran, chief and program director of Columbia University Medical Center’s division of colorectal surgery, presented findings from a large retrospective study that addressed whether oral antibiotics and mechanical bowel preparation reduced the risk of complications from colorectal surgery. Drawing from targeted colectomy data, available from 2012 onward through the large American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database, Dr. Kiran and associates compared three groups of patients undergoing elective colectomy. Of the total 8,644 patients, 2,498 (28.9%) received no preparation, 3,822 (44.2%) received mechanical bowel preparation alone, and 2,324 (26.9%) received both oral antibiotics and mechanical bowel preparation.

Primary outcome measures included the presence of anastomotic leak from the surgery, surgical site infections, ileus, and all-cause mortality. The patients were well matched by age and gender, and surgery type; case complexity and degree of resident physician involvement in the surgical procedures were also similar between arms.

On multivariable analysis, patients who received mechanical bowel preparation and oral antibiotics were significantly less likely to have surgical site infections (odds ratio, 0.43), to sustain ileus (OR, 0.71), or to have anastomotic leak (OR, 0.56). Postoperatively, those who had received no bowel preparation were also significantly more likely to have pneumonia, to require reintubation, and to fail to wean from the ventilator. They also were more likely to have deep vein thrombosis and sepsis. All-cause 30-day mortality was also significantly less likely in the group receiving both bowel preparation and oral antibiotics.

Dr. Kiran noted that investigators were not able to determine the type of mechanical bowel preparation patients received, and likely could not control for all confounders.

Discussant Dr. Heidi Nelson of the Mayo Clinic, Rochester, Minn., noted that despite the study’s strengths, including its large size and the real-world nature of the investigation, she doubts that the study will be considered definitive. Limitations that critics might point out, she noted, are the retrospective nature of the study and the possibility that the three groups studied were not really comparable because of subtle selection biases on the part of the treating surgeons. Dr. Kiran conceded that though multivariable analysis attempted to account and control for as many between-group differences as they could identify, differences probably did persist.

Dr. Hiram Polk of the University of Louisville (Ky.) commented that studies such as these using massive databases, though they may show what is true, may not always point to what is clinically relevant. Overall, it’s been shown that about one in four patients given systemic antibiotics are given the wrong drug, he said; further, “the only place you can truly sterilize a colon is in an autoclave.” Dr. Kiran did note that the combined oral preparation regime was successful in reducing the incidence of the most common complications by about 50%.

Following with more real-world observations, Dr. Mary Otterson of the Medical College of Wisconsin, Milwaukee, commented that the effective dose of preoperative erythromycin is very close to doses that cause significant nausea and vomiting. In her experience, “If we went any higher, they vomited. We also had unplanned admits with electrolyte abnormalities.” The best-tolerated and most effective regime, she said, should be identified by a prospective, randomized, controlled trial.

The authors reported no conflicts of interest.

The complete manuscript of this study and its presentation at the American Surgical Association’s 135th Annual Meeting, April 2015, in San Diego, California, are anticipated to be published in the Annals of Surgery pending editorial review.

SAN DIEGO – A combination of bowel cleansing and oral antibiotics nearly halved the risk of common and troublesome complications in colorectal surgery. Infections, leaks, and postsurgical ileus were all significantly less likely with the combined regime, according to a study reported at the annual meeting of the American Surgical Association.

Patients preparing for colorectal surgery routinely received mechanical bowel preparation in combination with oral antibiotics in the 1970s. However, since then, the availability of IV antibiotics combined with concerns about complications from bowel preparation have contributed to a decline in use of the regime. Consensus is lacking about best practices for preparation for colorectal surgery.

Dr. P. Ravi Kiran, chief and program director of Columbia University Medical Center’s division of colorectal surgery, presented findings from a large retrospective study that addressed whether oral antibiotics and mechanical bowel preparation reduced the risk of complications from colorectal surgery. Drawing from targeted colectomy data, available from 2012 onward through the large American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database, Dr. Kiran and associates compared three groups of patients undergoing elective colectomy. Of the total 8,644 patients, 2,498 (28.9%) received no preparation, 3,822 (44.2%) received mechanical bowel preparation alone, and 2,324 (26.9%) received both oral antibiotics and mechanical bowel preparation.

Primary outcome measures included the presence of anastomotic leak from the surgery, surgical site infections, ileus, and all-cause mortality. The patients were well matched by age and gender, and surgery type; case complexity and degree of resident physician involvement in the surgical procedures were also similar between arms.

On multivariable analysis, patients who received mechanical bowel preparation and oral antibiotics were significantly less likely to have surgical site infections (odds ratio, 0.43), to sustain ileus (OR, 0.71), or to have anastomotic leak (OR, 0.56). Postoperatively, those who had received no bowel preparation were also significantly more likely to have pneumonia, to require reintubation, and to fail to wean from the ventilator. They also were more likely to have deep vein thrombosis and sepsis. All-cause 30-day mortality was also significantly less likely in the group receiving both bowel preparation and oral antibiotics.

Dr. Kiran noted that investigators were not able to determine the type of mechanical bowel preparation patients received, and likely could not control for all confounders.

Discussant Dr. Heidi Nelson of the Mayo Clinic, Rochester, Minn., noted that despite the study’s strengths, including its large size and the real-world nature of the investigation, she doubts that the study will be considered definitive. Limitations that critics might point out, she noted, are the retrospective nature of the study and the possibility that the three groups studied were not really comparable because of subtle selection biases on the part of the treating surgeons. Dr. Kiran conceded that though multivariable analysis attempted to account and control for as many between-group differences as they could identify, differences probably did persist.

Dr. Hiram Polk of the University of Louisville (Ky.) commented that studies such as these using massive databases, though they may show what is true, may not always point to what is clinically relevant. Overall, it’s been shown that about one in four patients given systemic antibiotics are given the wrong drug, he said; further, “the only place you can truly sterilize a colon is in an autoclave.” Dr. Kiran did note that the combined oral preparation regime was successful in reducing the incidence of the most common complications by about 50%.

Following with more real-world observations, Dr. Mary Otterson of the Medical College of Wisconsin, Milwaukee, commented that the effective dose of preoperative erythromycin is very close to doses that cause significant nausea and vomiting. In her experience, “If we went any higher, they vomited. We also had unplanned admits with electrolyte abnormalities.” The best-tolerated and most effective regime, she said, should be identified by a prospective, randomized, controlled trial.

The authors reported no conflicts of interest.

The complete manuscript of this study and its presentation at the American Surgical Association’s 135th Annual Meeting, April 2015, in San Diego, California, are anticipated to be published in the Annals of Surgery pending editorial review.

SAN DIEGO – Patients hoping to avoid a permanent stoma by having a salvage surgery to repair or replace a failing ileal pouch–anal anastomosis (IPAA) achieved good functional outcomes and quality of life in one institution’s long-term experience.

A large case series drawn from IPAA re-dos at the Cleveland Clinic over a 20-year span showed that the procedure was successful for four in five patients, and more than 90% were satisfied with their quality of life, despite some functional limitations. Dr. Feza Remzi, chairman of the department of colorectal surgery at the Cleveland Clinic, presented findings from 500 patients undergoing IPAA re-dos via the transabdominal approach. In this group, 80% (401) of transabdominally revised IPAAs were successful.

IPAA is a procedure indicated for patients with Crohn’s disease, ulcerative or indeterminate colitis, or familial adenomatous polyposis. The surgery preserves the capacity for anal defecation with intestinal continuity after proctocolectomy by fashioning a reservoir for stool from the small intestine. However, up to 15% of patients will have pouch failure, necessitating a permanent stoma unless the pouch is surgically revised, he said at  the annual meeting of the American Surgical Association.

To determine outcomes for patients having a re-do of a failed IPAA, Dr. Remzi and colleagues assessed 502 IPAA re-do patients (215, male; median age, 38 years) who received their procedure at the Cleveland Clinic from 1983 to 2014. Crohn’s disease was the primary diagnosis for 419 patients (84%); just over half (n = 263) had anastomotic leak or fistula as the cause of first pouch failure, followed by pouch-vaginal fistula in 85 women (17%) and obstruction in 116 patients (23%).

The primary endpoints of the study were surgery morbidity, how many patients had a functioning pouch after re-do, pouch function, and quality of life.

Surgeon discretion dictated whether the pouch was revised, as it was in 295 patients (59%), or whether a new pouch was created. Overall, just over half of patients (n = 270) had postoperative complications, though there were no short-term deaths. Ileus and pelvic sepsis were the most common short-term complications, occurring in 81 (16%) and 50 (10%) patients, respectively. All of the other complications occurred in less than 10% of patients. Patients stayed in the hospital a median of 7 days, and 63 (13%) were readmitted.

Over the duration of the study, 101 patients (20%) had failure of their redone IPAA pouches, and pelvis sepsis and anastomotic stricture each occurred in more than 10% of patients. Short-term postoperative morbidity and occurrence of pelvic sepsis at any point after re-do surgery were associated with failure of the redone IPAA based on a Cox regression model (P = .035 and P < .0001, respectively).

Patients were overall very satisfied with their quality of life after IPAA re-do surgery; 92% of the 261 respondents said they would undergo the surgery again, and 93% would recommend the surgery. This was true although patients reported a mean of six daytime bowel movements, about half of patients reported having stool seepage or requiring pad use, and a third of patients reported dietary restrictions related to their bowel function.

Study limitations included the lack of information regarding patients in whom the re-do attempt was abandoned, or for those referred for surgery who did not have an IPAA re-do. Another limitation was the relatively low number of patients who completed all items on the function and quality of life questionnaires; investigators decided that the most robust analysis would flow from including only data for those who had completed all forms.

Discussion focused on the real-world and technical aspects of lessons learned from this large single-institution data set. Dr. David Rothenberger, Jay Phillips Professor and Chair of the department of surgery at the University of Minnesota, Minneapolis, asked whether patients had been carefully selected for this salvage procedure. In his experience, he said, obese patients or those with a heavily muscled pelvis, as well as those with a significant history of prior pelvic infections, would not necessarily be good candidates for a re-do. He suggested that an intention-to-treat analysis might give a truer denominator, and might even change the conclusion that the salvage surgery has a high likelihood of success. Dr. Remzi agreed that obesity or a high body mass index in a patient “is a very good reason not to do the surgery.”

Dr. Neil Hyman, codirector of the digestive diseases center at the University of Chicago Medicine, asked whether Dr. Remzi preferred to do an S pouch rather than a J pouch. In response, Dr. Remzi said, “We have to think about what the patient will give us. Throughout the years, I’ve learned that I like to divert the patient for 6 months before surgery. This gets them and their family engaged in the process. … It also elongates the mesentery to give you that reach. But I don’t necessarily do an intentional S pouch if the J pouch gives me what I need for the health of that patient.”

The authors reported no relevant financial disclosures.

SAN DIEGO – Patients hoping to avoid a permanent stoma by having a salvage surgery to repair or replace a failing ileal pouch–anal anastomosis (IPAA) achieved good functional outcomes and quality of life in one institution’s long-term experience.

A large case series drawn from IPAA re-dos at the Cleveland Clinic over a 20-year span showed that the procedure was successful for four in five patients, and more than 90% were satisfied with their quality of life, despite some functional limitations. Dr. Feza Remzi, chairman of the department of colorectal surgery at the Cleveland Clinic, presented findings from 500 patients undergoing IPAA re-dos via the transabdominal approach. In this group, 80% (401) of transabdominally revised IPAAs were successful.

IPAA is a procedure indicated for patients with Crohn’s disease, ulcerative or indeterminate colitis, or familial adenomatous polyposis. The surgery preserves the capacity for anal defecation with intestinal continuity after proctocolectomy by fashioning a reservoir for stool from the small intestine. However, up to 15% of patients will have pouch failure, necessitating a permanent stoma unless the pouch is surgically revised, he said at  the annual meeting of the American Surgical Association.

To determine outcomes for patients having a re-do of a failed IPAA, Dr. Remzi and colleagues assessed 502 IPAA re-do patients (215, male; median age, 38 years) who received their procedure at the Cleveland Clinic from 1983 to 2014. Crohn’s disease was the primary diagnosis for 419 patients (84%); just over half (n = 263) had anastomotic leak or fistula as the cause of first pouch failure, followed by pouch-vaginal fistula in 85 women (17%) and obstruction in 116 patients (23%).

The primary endpoints of the study were surgery morbidity, how many patients had a functioning pouch after re-do, pouch function, and quality of life.

Surgeon discretion dictated whether the pouch was revised, as it was in 295 patients (59%), or whether a new pouch was created. Overall, just over half of patients (n = 270) had postoperative complications, though there were no short-term deaths. Ileus and pelvic sepsis were the most common short-term complications, occurring in 81 (16%) and 50 (10%) patients, respectively. All of the other complications occurred in less than 10% of patients. Patients stayed in the hospital a median of 7 days, and 63 (13%) were readmitted.

Over the duration of the study, 101 patients (20%) had failure of their redone IPAA pouches, and pelvis sepsis and anastomotic stricture each occurred in more than 10% of patients. Short-term postoperative morbidity and occurrence of pelvic sepsis at any point after re-do surgery were associated with failure of the redone IPAA based on a Cox regression model (P = .035 and P < .0001, respectively).

Patients were overall very satisfied with their quality of life after IPAA re-do surgery; 92% of the 261 respondents said they would undergo the surgery again, and 93% would recommend the surgery. This was true although patients reported a mean of six daytime bowel movements, about half of patients reported having stool seepage or requiring pad use, and a third of patients reported dietary restrictions related to their bowel function.

Study limitations included the lack of information regarding patients in whom the re-do attempt was abandoned, or for those referred for surgery who did not have an IPAA re-do. Another limitation was the relatively low number of patients who completed all items on the function and quality of life questionnaires; investigators decided that the most robust analysis would flow from including only data for those who had completed all forms.

Discussion focused on the real-world and technical aspects of lessons learned from this large single-institution data set. Dr. David Rothenberger, Jay Phillips Professor and Chair of the department of surgery at the University of Minnesota, Minneapolis, asked whether patients had been carefully selected for this salvage procedure. In his experience, he said, obese patients or those with a heavily muscled pelvis, as well as those with a significant history of prior pelvic infections, would not necessarily be good candidates for a re-do. He suggested that an intention-to-treat analysis might give a truer denominator, and might even change the conclusion that the salvage surgery has a high likelihood of success. Dr. Remzi agreed that obesity or a high body mass index in a patient “is a very good reason not to do the surgery.”

Dr. Neil Hyman, codirector of the digestive diseases center at the University of Chicago Medicine, asked whether Dr. Remzi preferred to do an S pouch rather than a J pouch. In response, Dr. Remzi said, “We have to think about what the patient will give us. Throughout the years, I’ve learned that I like to divert the patient for 6 months before surgery. This gets them and their family engaged in the process. … It also elongates the mesentery to give you that reach. But I don’t necessarily do an intentional S pouch if the J pouch gives me what I need for the health of that patient.”

The authors reported no relevant financial disclosures.

SAN DIEGO – Patients hoping to avoid a permanent stoma by having a salvage surgery to repair or replace a failing ileal pouch–anal anastomosis (IPAA) achieved good functional outcomes and quality of life in one institution’s long-term experience.

A large case series drawn from IPAA re-dos at the Cleveland Clinic over a 20-year span showed that the procedure was successful for four in five patients, and more than 90% were satisfied with their quality of life, despite some functional limitations. Dr. Feza Remzi, chairman of the department of colorectal surgery at the Cleveland Clinic, presented findings from 500 patients undergoing IPAA re-dos via the transabdominal approach. In this group, 80% (401) of transabdominally revised IPAAs were successful.

IPAA is a procedure indicated for patients with Crohn’s disease, ulcerative or indeterminate colitis, or familial adenomatous polyposis. The surgery preserves the capacity for anal defecation with intestinal continuity after proctocolectomy by fashioning a reservoir for stool from the small intestine. However, up to 15% of patients will have pouch failure, necessitating a permanent stoma unless the pouch is surgically revised, he said at  the annual meeting of the American Surgical Association.

To determine outcomes for patients having a re-do of a failed IPAA, Dr. Remzi and colleagues assessed 502 IPAA re-do patients (215, male; median age, 38 years) who received their procedure at the Cleveland Clinic from 1983 to 2014. Crohn’s disease was the primary diagnosis for 419 patients (84%); just over half (n = 263) had anastomotic leak or fistula as the cause of first pouch failure, followed by pouch-vaginal fistula in 85 women (17%) and obstruction in 116 patients (23%).

The primary endpoints of the study were surgery morbidity, how many patients had a functioning pouch after re-do, pouch function, and quality of life.

Surgeon discretion dictated whether the pouch was revised, as it was in 295 patients (59%), or whether a new pouch was created. Overall, just over half of patients (n = 270) had postoperative complications, though there were no short-term deaths. Ileus and pelvic sepsis were the most common short-term complications, occurring in 81 (16%) and 50 (10%) patients, respectively. All of the other complications occurred in less than 10% of patients. Patients stayed in the hospital a median of 7 days, and 63 (13%) were readmitted.

Over the duration of the study, 101 patients (20%) had failure of their redone IPAA pouches, and pelvis sepsis and anastomotic stricture each occurred in more than 10% of patients. Short-term postoperative morbidity and occurrence of pelvic sepsis at any point after re-do surgery were associated with failure of the redone IPAA based on a Cox regression model (P = .035 and P < .0001, respectively).

Patients were overall very satisfied with their quality of life after IPAA re-do surgery; 92% of the 261 respondents said they would undergo the surgery again, and 93% would recommend the surgery. This was true although patients reported a mean of six daytime bowel movements, about half of patients reported having stool seepage or requiring pad use, and a third of patients reported dietary restrictions related to their bowel function.

Study limitations included the lack of information regarding patients in whom the re-do attempt was abandoned, or for those referred for surgery who did not have an IPAA re-do. Another limitation was the relatively low number of patients who completed all items on the function and quality of life questionnaires; investigators decided that the most robust analysis would flow from including only data for those who had completed all forms.

Discussion focused on the real-world and technical aspects of lessons learned from this large single-institution data set. Dr. David Rothenberger, Jay Phillips Professor and Chair of the department of surgery at the University of Minnesota, Minneapolis, asked whether patients had been carefully selected for this salvage procedure. In his experience, he said, obese patients or those with a heavily muscled pelvis, as well as those with a significant history of prior pelvic infections, would not necessarily be good candidates for a re-do. He suggested that an intention-to-treat analysis might give a truer denominator, and might even change the conclusion that the salvage surgery has a high likelihood of success. Dr. Remzi agreed that obesity or a high body mass index in a patient “is a very good reason not to do the surgery.”

Dr. Neil Hyman, codirector of the digestive diseases center at the University of Chicago Medicine, asked whether Dr. Remzi preferred to do an S pouch rather than a J pouch. In response, Dr. Remzi said, “We have to think about what the patient will give us. Throughout the years, I’ve learned that I like to divert the patient for 6 months before surgery. This gets them and their family engaged in the process. … It also elongates the mesentery to give you that reach. But I don’t necessarily do an intentional S pouch if the J pouch gives me what I need for the health of that patient.”

The authors reported no relevant financial disclosures.

HOUSTON – Surgical-site infections occurring in patients who underwent curative resection for localized colon cancer were associated with worse overall survival in a large retrospective study.

Among nearly 10,000 patients with nonmetastatic colon cancer who underwent surgery with curative intent, surgical-site infections (SSIs) were associated with both worse overall survival and a reduced likelihood of receiving adjuvant chemotherapy, reported Dr. Gala Markia Barden, a surgical resident at Baylor College of Medicine, Houston.

Both SSIs and failure to receive adjuvant chemotherapy are independently associated with worse overall survival, she said at the annual Society of Surgical Oncology Cancer Symposium.

“Future studies and practice guidelines should focus on target areas for improving these potentially preventable problems, including active surveillance for and early recognition of surgical-site infections, as well as vigilant follow-up to ensure treatment completion and to improve the transition between the surgical and medical oncology teams to mitigate losses to follow-up,” she said.

Tapping into the merged Veterans Affairs Surgical Quality Improvement Program and VA Central Cancer Registry (VASQIP-VA) databases, the authors identified 9,946 patients aged 18 years and older who underwent radical resection for colon cancer from 1999 through 2009. Patients with rectal cancers or early postoperative deaths (within 90 days of surgery) were excluded.

The investigators examined the relationships between SSIs and both 5-year overall survival and receipt of adjuvant chemotherapy, which has been documented to improve survival in patients with stage III colon cancer. Delivery of adjuvant chemotherapy in these patients is considered to be a measure of the quality of cancer care, Dr. Barden noted.

Of the 9,946 patients included in the study, 1,340 (13.5%) developed SSIs. These patients were slightly but significantly younger (P < .001), had worse functional status (P = .002), and had higher American Society of Anesthesiologists (ASA) physical status scores (P < .001).

In univariate analysis, the investigators found that, in the entire cohort, SSIs were associated with worse overall survival (OS); in multivariate analysis controlling for sex, nutrition, functional status, ASA score, and number of lymph nodes resected, they saw that SSI was associated with a hazard ratio (HR) for worse overall survival of 1.35 (P < .0001).

When they looked at the association of SSI and OS stratified by cancer stage, however, they found that it was significant only for stage III disease. Patients with stage III who developed an SSI had a median OS of 29 months, compared with 33 months for those with no site infections (P< .001).

Dr. Barden and her associates also found that 42% of patients with infections did not receive adjuvant chemotherapy, compared with 34% of patients without SSIs (P = .002).

To see whether the worse survival among patients with SSI was primarily driven by the failure to deliver chemotherapy, they created a model adjusted for cancer risk factors, which showed that patients with stage III disease who developed an SSI and did not undergo adjuvant chemotherapy had an HR of worse overall survival of 1.59 (P < .0001).

They then added into the model those patients with SSIs who did receive adjuvant therapy but, contrary to their expectations, saw that the HR was only slightly reduced (1.56) and remained significant (P < .0001). The model also confirmed that failure to deliver chemotherapy was associated with worse survival (HR 1.52, P <.0001)

Dr. Barden acknowledged that the study was limited by the retrospective design, predominantly male VA cohort, and the lack of information in the databases about why patients did not receive adjuvant therapy.

The study was internally supported. Dr. Barden reported having no conflicts of interest.

HOUSTON – Surgical-site infections occurring in patients who underwent curative resection for localized colon cancer were associated with worse overall survival in a large retrospective study.

Among nearly 10,000 patients with nonmetastatic colon cancer who underwent surgery with curative intent, surgical-site infections (SSIs) were associated with both worse overall survival and a reduced likelihood of receiving adjuvant chemotherapy, reported Dr. Gala Markia Barden, a surgical resident at Baylor College of Medicine, Houston.

Both SSIs and failure to receive adjuvant chemotherapy are independently associated with worse overall survival, she said at the annual Society of Surgical Oncology Cancer Symposium.

“Future studies and practice guidelines should focus on target areas for improving these potentially preventable problems, including active surveillance for and early recognition of surgical-site infections, as well as vigilant follow-up to ensure treatment completion and to improve the transition between the surgical and medical oncology teams to mitigate losses to follow-up,” she said.

Tapping into the merged Veterans Affairs Surgical Quality Improvement Program and VA Central Cancer Registry (VASQIP-VA) databases, the authors identified 9,946 patients aged 18 years and older who underwent radical resection for colon cancer from 1999 through 2009. Patients with rectal cancers or early postoperative deaths (within 90 days of surgery) were excluded.

The investigators examined the relationships between SSIs and both 5-year overall survival and receipt of adjuvant chemotherapy, which has been documented to improve survival in patients with stage III colon cancer. Delivery of adjuvant chemotherapy in these patients is considered to be a measure of the quality of cancer care, Dr. Barden noted.

Of the 9,946 patients included in the study, 1,340 (13.5%) developed SSIs. These patients were slightly but significantly younger (P < .001), had worse functional status (P = .002), and had higher American Society of Anesthesiologists (ASA) physical status scores (P < .001).

In univariate analysis, the investigators found that, in the entire cohort, SSIs were associated with worse overall survival (OS); in multivariate analysis controlling for sex, nutrition, functional status, ASA score, and number of lymph nodes resected, they saw that SSI was associated with a hazard ratio (HR) for worse overall survival of 1.35 (P < .0001).

When they looked at the association of SSI and OS stratified by cancer stage, however, they found that it was significant only for stage III disease. Patients with stage III who developed an SSI had a median OS of 29 months, compared with 33 months for those with no site infections (P< .001).

Dr. Barden and her associates also found that 42% of patients with infections did not receive adjuvant chemotherapy, compared with 34% of patients without SSIs (P = .002).

To see whether the worse survival among patients with SSI was primarily driven by the failure to deliver chemotherapy, they created a model adjusted for cancer risk factors, which showed that patients with stage III disease who developed an SSI and did not undergo adjuvant chemotherapy had an HR of worse overall survival of 1.59 (P < .0001).

They then added into the model those patients with SSIs who did receive adjuvant therapy but, contrary to their expectations, saw that the HR was only slightly reduced (1.56) and remained significant (P < .0001). The model also confirmed that failure to deliver chemotherapy was associated with worse survival (HR 1.52, P <.0001)

Dr. Barden acknowledged that the study was limited by the retrospective design, predominantly male VA cohort, and the lack of information in the databases about why patients did not receive adjuvant therapy.

The study was internally supported. Dr. Barden reported having no conflicts of interest.

HOUSTON – Surgical-site infections occurring in patients who underwent curative resection for localized colon cancer were associated with worse overall survival in a large retrospective study.

Among nearly 10,000 patients with nonmetastatic colon cancer who underwent surgery with curative intent, surgical-site infections (SSIs) were associated with both worse overall survival and a reduced likelihood of receiving adjuvant chemotherapy, reported Dr. Gala Markia Barden, a surgical resident at Baylor College of Medicine, Houston.

Both SSIs and failure to receive adjuvant chemotherapy are independently associated with worse overall survival, she said at the annual Society of Surgical Oncology Cancer Symposium.

“Future studies and practice guidelines should focus on target areas for improving these potentially preventable problems, including active surveillance for and early recognition of surgical-site infections, as well as vigilant follow-up to ensure treatment completion and to improve the transition between the surgical and medical oncology teams to mitigate losses to follow-up,” she said.

Tapping into the merged Veterans Affairs Surgical Quality Improvement Program and VA Central Cancer Registry (VASQIP-VA) databases, the authors identified 9,946 patients aged 18 years and older who underwent radical resection for colon cancer from 1999 through 2009. Patients with rectal cancers or early postoperative deaths (within 90 days of surgery) were excluded.

The investigators examined the relationships between SSIs and both 5-year overall survival and receipt of adjuvant chemotherapy, which has been documented to improve survival in patients with stage III colon cancer. Delivery of adjuvant chemotherapy in these patients is considered to be a measure of the quality of cancer care, Dr. Barden noted.

Of the 9,946 patients included in the study, 1,340 (13.5%) developed SSIs. These patients were slightly but significantly younger (P < .001), had worse functional status (P = .002), and had higher American Society of Anesthesiologists (ASA) physical status scores (P < .001).

In univariate analysis, the investigators found that, in the entire cohort, SSIs were associated with worse overall survival (OS); in multivariate analysis controlling for sex, nutrition, functional status, ASA score, and number of lymph nodes resected, they saw that SSI was associated with a hazard ratio (HR) for worse overall survival of 1.35 (P < .0001).

When they looked at the association of SSI and OS stratified by cancer stage, however, they found that it was significant only for stage III disease. Patients with stage III who developed an SSI had a median OS of 29 months, compared with 33 months for those with no site infections (P< .001).

Dr. Barden and her associates also found that 42% of patients with infections did not receive adjuvant chemotherapy, compared with 34% of patients without SSIs (P = .002).

To see whether the worse survival among patients with SSI was primarily driven by the failure to deliver chemotherapy, they created a model adjusted for cancer risk factors, which showed that patients with stage III disease who developed an SSI and did not undergo adjuvant chemotherapy had an HR of worse overall survival of 1.59 (P < .0001).

They then added into the model those patients with SSIs who did receive adjuvant therapy but, contrary to their expectations, saw that the HR was only slightly reduced (1.56) and remained significant (P < .0001). The model also confirmed that failure to deliver chemotherapy was associated with worse survival (HR 1.52, P <.0001)

Dr. Barden acknowledged that the study was limited by the retrospective design, predominantly male VA cohort, and the lack of information in the databases about why patients did not receive adjuvant therapy.

The study was internally supported. Dr. Barden reported having no conflicts of interest.

HOUSTON – Patients who achieve complete clinical responses after neoadjuvant therapy for locally advanced rectal cancer may, in many cases, be safely spared the trauma and morbidity of total mesorectal excision.

That’s the opinion of investigators at Memorial Sloan Kettering Cancer Center, New York, who found that nearly two-thirds of patients followed with nonoperative management (NOM) had durable complete clinical remissions (cCR) for at least 4 years.

Disease-specific survival and overall survival rates among patients who had nonoperative management were similar to those seen in patients with pathologic complete responses (pCR), defined as no viable tumor cells in the resected specimen.

“We know that there is a very good overall and disease-free survival associated with a [pCR]. Clinical complete response is also associated with pathologic complete response. In that regard, this brings up the question: Is an operation always necessary in these patients?” Dr. Jesse Joshua Smith of the cancer center said at the annual Society of Surgical Oncology Cancer Symposium.

Dr. Smith and colleagues conducted a review of their center’s experience to date with NOM for patients with locally advanced rectal cancer, asking whether the data support the approach as oncologically safe and effective for organ preservation.

They identified 442 patients with rectal cancer treated with neoadjuvant chemotherapy from 2006 through 2014 and compared results for 73 who achieved a cCR and were followed with nonoperative management with those of 72 patients who had a pCR following total mesorectal excision.

Demographic and clinical characteristics between the groups were generally similar, although patients in the pCR group were significantly younger (58 years vs. 65 years, P = .01), had a greater tumor distance from the anal verge (median of 6 cm vs. 5.25 cm, P = .02), and higher proportions of clinical stage II (32% vs. 24%) and III (66% vs. 62%, P = .02).

Among the 73 patients managed with NOM, 54 had durable cCR at 4 years. Of the remaining 19 with local tumor regrowth, 2 had local excisions with no further recurrence and 17 went on to have rectal resections. The total number of patients with rectal preservation in this group was 56 (77%).

Of the 19 patients in the conservatively managed group who had local regrowths, all but three of the recurrences were detected within 13 months.

As noted before, neither disease-specific survival nor overall survival were significantly different between patients managed with NOM or with total mesorectal excision.

There were numerically more distant recurrences at both 1 and 4 years among patients treated with NOM compared with total mesorectal excision (7% vs. 2%, and 17% vs. 9%, respectively), but the differences were not statistically significant, the authors found.

Dr. Smith noted that patients who are offered the option of NOM have a discussion with the surgeon emphasizing that the practice is nonstandard management, carries about a 25% risk of local regrowth, and requires increased endoscopic and radiographic surveillance. Patients also are informed about the risks of salvage abdominoperineal resection or extended resections, and about the potential risk of compromising cure.

The study was supported in part by the Berezuk Colorectal Cancer Fund. Dr. Smith reported having no disclosures.

HOUSTON – Patients who achieve complete clinical responses after neoadjuvant therapy for locally advanced rectal cancer may, in many cases, be safely spared the trauma and morbidity of total mesorectal excision.

That’s the opinion of investigators at Memorial Sloan Kettering Cancer Center, New York, who found that nearly two-thirds of patients followed with nonoperative management (NOM) had durable complete clinical remissions (cCR) for at least 4 years.

Disease-specific survival and overall survival rates among patients who had nonoperative management were similar to those seen in patients with pathologic complete responses (pCR), defined as no viable tumor cells in the resected specimen.

“We know that there is a very good overall and disease-free survival associated with a [pCR]. Clinical complete response is also associated with pathologic complete response. In that regard, this brings up the question: Is an operation always necessary in these patients?” Dr. Jesse Joshua Smith of the cancer center said at the annual Society of Surgical Oncology Cancer Symposium.

Dr. Smith and colleagues conducted a review of their center’s experience to date with NOM for patients with locally advanced rectal cancer, asking whether the data support the approach as oncologically safe and effective for organ preservation.

They identified 442 patients with rectal cancer treated with neoadjuvant chemotherapy from 2006 through 2014 and compared results for 73 who achieved a cCR and were followed with nonoperative management with those of 72 patients who had a pCR following total mesorectal excision.

Demographic and clinical characteristics between the groups were generally similar, although patients in the pCR group were significantly younger (58 years vs. 65 years, P = .01), had a greater tumor distance from the anal verge (median of 6 cm vs. 5.25 cm, P = .02), and higher proportions of clinical stage II (32% vs. 24%) and III (66% vs. 62%, P = .02).

Among the 73 patients managed with NOM, 54 had durable cCR at 4 years. Of the remaining 19 with local tumor regrowth, 2 had local excisions with no further recurrence and 17 went on to have rectal resections. The total number of patients with rectal preservation in this group was 56 (77%).

Of the 19 patients in the conservatively managed group who had local regrowths, all but three of the recurrences were detected within 13 months.

As noted before, neither disease-specific survival nor overall survival were significantly different between patients managed with NOM or with total mesorectal excision.

There were numerically more distant recurrences at both 1 and 4 years among patients treated with NOM compared with total mesorectal excision (7% vs. 2%, and 17% vs. 9%, respectively), but the differences were not statistically significant, the authors found.

Dr. Smith noted that patients who are offered the option of NOM have a discussion with the surgeon emphasizing that the practice is nonstandard management, carries about a 25% risk of local regrowth, and requires increased endoscopic and radiographic surveillance. Patients also are informed about the risks of salvage abdominoperineal resection or extended resections, and about the potential risk of compromising cure.

The study was supported in part by the Berezuk Colorectal Cancer Fund. Dr. Smith reported having no disclosures.

HOUSTON – Patients who achieve complete clinical responses after neoadjuvant therapy for locally advanced rectal cancer may, in many cases, be safely spared the trauma and morbidity of total mesorectal excision.

That’s the opinion of investigators at Memorial Sloan Kettering Cancer Center, New York, who found that nearly two-thirds of patients followed with nonoperative management (NOM) had durable complete clinical remissions (cCR) for at least 4 years.

Disease-specific survival and overall survival rates among patients who had nonoperative management were similar to those seen in patients with pathologic complete responses (pCR), defined as no viable tumor cells in the resected specimen.

“We know that there is a very good overall and disease-free survival associated with a [pCR]. Clinical complete response is also associated with pathologic complete response. In that regard, this brings up the question: Is an operation always necessary in these patients?” Dr. Jesse Joshua Smith of the cancer center said at the annual Society of Surgical Oncology Cancer Symposium.

Dr. Smith and colleagues conducted a review of their center’s experience to date with NOM for patients with locally advanced rectal cancer, asking whether the data support the approach as oncologically safe and effective for organ preservation.

They identified 442 patients with rectal cancer treated with neoadjuvant chemotherapy from 2006 through 2014 and compared results for 73 who achieved a cCR and were followed with nonoperative management with those of 72 patients who had a pCR following total mesorectal excision.

Demographic and clinical characteristics between the groups were generally similar, although patients in the pCR group were significantly younger (58 years vs. 65 years, P = .01), had a greater tumor distance from the anal verge (median of 6 cm vs. 5.25 cm, P = .02), and higher proportions of clinical stage II (32% vs. 24%) and III (66% vs. 62%, P = .02).

Among the 73 patients managed with NOM, 54 had durable cCR at 4 years. Of the remaining 19 with local tumor regrowth, 2 had local excisions with no further recurrence and 17 went on to have rectal resections. The total number of patients with rectal preservation in this group was 56 (77%).

Of the 19 patients in the conservatively managed group who had local regrowths, all but three of the recurrences were detected within 13 months.

As noted before, neither disease-specific survival nor overall survival were significantly different between patients managed with NOM or with total mesorectal excision.

There were numerically more distant recurrences at both 1 and 4 years among patients treated with NOM compared with total mesorectal excision (7% vs. 2%, and 17% vs. 9%, respectively), but the differences were not statistically significant, the authors found.

Dr. Smith noted that patients who are offered the option of NOM have a discussion with the surgeon emphasizing that the practice is nonstandard management, carries about a 25% risk of local regrowth, and requires increased endoscopic and radiographic surveillance. Patients also are informed about the risks of salvage abdominoperineal resection or extended resections, and about the potential risk of compromising cure.

The study was supported in part by the Berezuk Colorectal Cancer Fund. Dr. Smith reported having no disclosures.

HOUSTON – A simple preoperative scale can accurately predict a patient’s risk for near-term death following surgery for gastric cancer, investigators say.

The scale accounts for both patient and hospital factors, and is useful as a clinical tool for preoperative counseling of patients, reported Dr. Cristina Harnsberger of the University of California San Diego.

“Male gender, increasing age, and comorbid disease increase risk of in-hospital mortality for patients who undergo gastric resection for malignancy. Additionally, low hospital volume was an independent risk factor,” she said at the annual Society of Surgical Oncology Cancer Symposium.

The scale was able to accurately classify patients as being at low or high risk, and the observed and expected mortality rates for each risk score were well correlated, she said.

Weighing risks

Perioperative mortality rates following resection for gastric malignancies range from 0.6% to 15%. Risk scales and nomograms are intended to help clinicians predict risks for individual patients, but most incorporate postoperative data rather than preoperative or hospital data, Dr. Harnsberger said.

She and her colleagues conducted a study to determine whether a simple preoperative scale based on patient and hospital factors could accurately predict risk for death following gastric resection for malignancy.

They drew on data from the Nationwide Inpatient Sample database to identify adult patients with a diagnosis of gastric cancer who underwent potentially curative partial or total gastrectomy from 1998 through 2011.

They identified a total 24,538 patients, based on International Classification of Diseases, Revision 9 (ICD-9) diagnosis and procedure codes.

They then created multivariate logistic regression models to identify independent predictors of mortality, create a predictive model, and construct a risk scale. The models controlled for sex, age, race, comorbidities, insurance status, hospital volume (less than 25 vs. 25 or more gastric resections for malignancy per year), laparoscopic vs. open approach, poverty level, alcohol abuse, tobacco use, diabetes mellitus, and year of procedure.

The mean length of stay for the patient sample was 11 days. The overall in-hospital mortality was 5.5%.

The models identified three patient-related factors and one hospital-related factor that were predictive of mortality and when combined in a risk scale proved to be accurate.

The patient factors were male sex, age 65 and older, and comorbid disease, specifically cardiovascular, pulmonary, renal, and/or hepatic.

The hospital factor, expressed as protective, was 25 or more gastric resections for cancer per year.

The maximum possible score is 13. Patients with scores lower than 6 are at low risk for perioperative mortality, while those with scores 6 and higher are at high risk. Among patients with a score of 0-5, the perioperative death rate ranged from 1.3% to 4.5%. In contrast, patients with higher scores had death rates ranging from 6.0% to 23.1%.

Clinical applications for the bedside risk scale include perioperative patient counseling, aiding in informed consent discussions, and as an adjunct to postoperative risk calculators, Dr. Harnsberger said.The study funding source was not disclosed. Dr. Harnsberger reported having no disclosures.

HOUSTON – A simple preoperative scale can accurately predict a patient’s risk for near-term death following surgery for gastric cancer, investigators say.

The scale accounts for both patient and hospital factors, and is useful as a clinical tool for preoperative counseling of patients, reported Dr. Cristina Harnsberger of the University of California San Diego.

“Male gender, increasing age, and comorbid disease increase risk of in-hospital mortality for patients who undergo gastric resection for malignancy. Additionally, low hospital volume was an independent risk factor,” she said at the annual Society of Surgical Oncology Cancer Symposium.

The scale was able to accurately classify patients as being at low or high risk, and the observed and expected mortality rates for each risk score were well correlated, she said.

Weighing risks

Perioperative mortality rates following resection for gastric malignancies range from 0.6% to 15%. Risk scales and nomograms are intended to help clinicians predict risks for individual patients, but most incorporate postoperative data rather than preoperative or hospital data, Dr. Harnsberger said.

She and her colleagues conducted a study to determine whether a simple preoperative scale based on patient and hospital factors could accurately predict risk for death following gastric resection for malignancy.

They drew on data from the Nationwide Inpatient Sample database to identify adult patients with a diagnosis of gastric cancer who underwent potentially curative partial or total gastrectomy from 1998 through 2011.

They identified a total 24,538 patients, based on International Classification of Diseases, Revision 9 (ICD-9) diagnosis and procedure codes.

They then created multivariate logistic regression models to identify independent predictors of mortality, create a predictive model, and construct a risk scale. The models controlled for sex, age, race, comorbidities, insurance status, hospital volume (less than 25 vs. 25 or more gastric resections for malignancy per year), laparoscopic vs. open approach, poverty level, alcohol abuse, tobacco use, diabetes mellitus, and year of procedure.

The mean length of stay for the patient sample was 11 days. The overall in-hospital mortality was 5.5%.

The models identified three patient-related factors and one hospital-related factor that were predictive of mortality and when combined in a risk scale proved to be accurate.

The patient factors were male sex, age 65 and older, and comorbid disease, specifically cardiovascular, pulmonary, renal, and/or hepatic.

The hospital factor, expressed as protective, was 25 or more gastric resections for cancer per year.

The maximum possible score is 13. Patients with scores lower than 6 are at low risk for perioperative mortality, while those with scores 6 and higher are at high risk. Among patients with a score of 0-5, the perioperative death rate ranged from 1.3% to 4.5%. In contrast, patients with higher scores had death rates ranging from 6.0% to 23.1%.

Clinical applications for the bedside risk scale include perioperative patient counseling, aiding in informed consent discussions, and as an adjunct to postoperative risk calculators, Dr. Harnsberger said.The study funding source was not disclosed. Dr. Harnsberger reported having no disclosures.

HOUSTON – A simple preoperative scale can accurately predict a patient’s risk for near-term death following surgery for gastric cancer, investigators say.

The scale accounts for both patient and hospital factors, and is useful as a clinical tool for preoperative counseling of patients, reported Dr. Cristina Harnsberger of the University of California San Diego.

“Male gender, increasing age, and comorbid disease increase risk of in-hospital mortality for patients who undergo gastric resection for malignancy. Additionally, low hospital volume was an independent risk factor,” she said at the annual Society of Surgical Oncology Cancer Symposium.

The scale was able to accurately classify patients as being at low or high risk, and the observed and expected mortality rates for each risk score were well correlated, she said.

Weighing risks

Perioperative mortality rates following resection for gastric malignancies range from 0.6% to 15%. Risk scales and nomograms are intended to help clinicians predict risks for individual patients, but most incorporate postoperative data rather than preoperative or hospital data, Dr. Harnsberger said.

She and her colleagues conducted a study to determine whether a simple preoperative scale based on patient and hospital factors could accurately predict risk for death following gastric resection for malignancy.

They drew on data from the Nationwide Inpatient Sample database to identify adult patients with a diagnosis of gastric cancer who underwent potentially curative partial or total gastrectomy from 1998 through 2011.

They identified a total 24,538 patients, based on International Classification of Diseases, Revision 9 (ICD-9) diagnosis and procedure codes.

They then created multivariate logistic regression models to identify independent predictors of mortality, create a predictive model, and construct a risk scale. The models controlled for sex, age, race, comorbidities, insurance status, hospital volume (less than 25 vs. 25 or more gastric resections for malignancy per year), laparoscopic vs. open approach, poverty level, alcohol abuse, tobacco use, diabetes mellitus, and year of procedure.

The mean length of stay for the patient sample was 11 days. The overall in-hospital mortality was 5.5%.

The models identified three patient-related factors and one hospital-related factor that were predictive of mortality and when combined in a risk scale proved to be accurate.

The patient factors were male sex, age 65 and older, and comorbid disease, specifically cardiovascular, pulmonary, renal, and/or hepatic.

The hospital factor, expressed as protective, was 25 or more gastric resections for cancer per year.

The maximum possible score is 13. Patients with scores lower than 6 are at low risk for perioperative mortality, while those with scores 6 and higher are at high risk. Among patients with a score of 0-5, the perioperative death rate ranged from 1.3% to 4.5%. In contrast, patients with higher scores had death rates ranging from 6.0% to 23.1%.

Clinical applications for the bedside risk scale include perioperative patient counseling, aiding in informed consent discussions, and as an adjunct to postoperative risk calculators, Dr. Harnsberger said.The study funding source was not disclosed. Dr. Harnsberger reported having no disclosures.

Laparoscopic resection of rectal cancer is noninferior to open surgery in preventing locoregional recurrence and in improving overall and disease-free survival, according to a report published online April 1 in the New England Journal of Medicine.

The laparoscopic approach has increasingly replaced open surgery in recent years, primarily because it offers short-term advantages such as less pain, reduced blood loss, and a shorter recovery time. But no large randomized trials have established that long-term outcomes with laparoscopic resection, including survival, are at least noninferior to those with open surgery, said Dr. Hendrik Jaap Bonjer of VU University Medical Center, Amsterdam, and his associates.

They now report the 3-year outcomes of the Colorectal Cancer Laparoscopic or Open Resection (COLOR) II trial, an industry-sponsored noninferiority study performed at 30 medical centers in eight countries in Europe, North America, and Asia. The trial involved 1,044 patients who had solitary, noninvasive adenocarcinomas of the rectum within 15 cm of the anal verge. A total of 699 of the study participants were randomly assigned to laparoscopic and 345 to open surgery.

At 3-year follow-up, the rate of locoregional recurrence was identical between the two study groups, at 5% each. In addition, rates of disease-free survival slightly favored the laparoscopic approach (74.8%) over the open approach (70.8%), as did rates of overall survival (86.7% and 83.6%, respectively) and rates of distant metastases (19.1% and 22.1%, respectively). Patients with stage III disease appeared to benefit the most from laparoscopic surgery, with disease-free survival of 64.9% vs. 52.0%, the investigators said (N. Engl. J. Med. 2015 April 1 [doi:10.1056/NEJMoa1414882]). These findings support the idea that the reduced surgical trauma associated with laparoscopic techniques may decrease tumor recurrence, perhaps by attenuating stress responses and preserving immune function, they noted.

“In our study, laparoscopic surgery in patients with cancer in the lower third of the rectum was associated with a lower rate of involved circumferential resection margin and a lower locoregional recurrence rate than was open surgery. During laparoscopic surgery, narrow spaces such as the lower pelvis are better visualized than in open surgery, owing to the use of a laparoscope, which projects a magnified and well-illuminated image of the operative field on the monitors. A clear view is of paramount importance to accomplish a resection of the cancer with sufficient margins,” Dr. Bonjer and his associates added.

The trial was funded by Ethicon Endo-Surgery Europe, a subsidiary of Johnson & Johnson; the Swedish Cancer Society; the Health and Medical Care Committee of Region Vastra Gotaland; Sahlgrenska University Hospital; Erasmus University Medical Center; Dahousie University; and VU University Medical Center. Dr. Bonjer reported having no disclosures; two of his associates reported ties to AbbVie, Merck Sharp & Dohme, Takeda, Johnson & Johnson, Covidien, Olympus Medical, and Applied Medical.

Laparoscopic resection of rectal cancer is noninferior to open surgery in preventing locoregional recurrence and in improving overall and disease-free survival, according to a report published online April 1 in the New England Journal of Medicine.

The laparoscopic approach has increasingly replaced open surgery in recent years, primarily because it offers short-term advantages such as less pain, reduced blood loss, and a shorter recovery time. But no large randomized trials have established that long-term outcomes with laparoscopic resection, including survival, are at least noninferior to those with open surgery, said Dr. Hendrik Jaap Bonjer of VU University Medical Center, Amsterdam, and his associates.

They now report the 3-year outcomes of the Colorectal Cancer Laparoscopic or Open Resection (COLOR) II trial, an industry-sponsored noninferiority study performed at 30 medical centers in eight countries in Europe, North America, and Asia. The trial involved 1,044 patients who had solitary, noninvasive adenocarcinomas of the rectum within 15 cm of the anal verge. A total of 699 of the study participants were randomly assigned to laparoscopic and 345 to open surgery.

At 3-year follow-up, the rate of locoregional recurrence was identical between the two study groups, at 5% each. In addition, rates of disease-free survival slightly favored the laparoscopic approach (74.8%) over the open approach (70.8%), as did rates of overall survival (86.7% and 83.6%, respectively) and rates of distant metastases (19.1% and 22.1%, respectively). Patients with stage III disease appeared to benefit the most from laparoscopic surgery, with disease-free survival of 64.9% vs. 52.0%, the investigators said (N. Engl. J. Med. 2015 April 1 [doi:10.1056/NEJMoa1414882]). These findings support the idea that the reduced surgical trauma associated with laparoscopic techniques may decrease tumor recurrence, perhaps by attenuating stress responses and preserving immune function, they noted.

“In our study, laparoscopic surgery in patients with cancer in the lower third of the rectum was associated with a lower rate of involved circumferential resection margin and a lower locoregional recurrence rate than was open surgery. During laparoscopic surgery, narrow spaces such as the lower pelvis are better visualized than in open surgery, owing to the use of a laparoscope, which projects a magnified and well-illuminated image of the operative field on the monitors. A clear view is of paramount importance to accomplish a resection of the cancer with sufficient margins,” Dr. Bonjer and his associates added.

The trial was funded by Ethicon Endo-Surgery Europe, a subsidiary of Johnson & Johnson; the Swedish Cancer Society; the Health and Medical Care Committee of Region Vastra Gotaland; Sahlgrenska University Hospital; Erasmus University Medical Center; Dahousie University; and VU University Medical Center. Dr. Bonjer reported having no disclosures; two of his associates reported ties to AbbVie, Merck Sharp & Dohme, Takeda, Johnson & Johnson, Covidien, Olympus Medical, and Applied Medical.

Laparoscopic resection of rectal cancer is noninferior to open surgery in preventing locoregional recurrence and in improving overall and disease-free survival, according to a report published online April 1 in the New England Journal of Medicine.

The laparoscopic approach has increasingly replaced open surgery in recent years, primarily because it offers short-term advantages such as less pain, reduced blood loss, and a shorter recovery time. But no large randomized trials have established that long-term outcomes with laparoscopic resection, including survival, are at least noninferior to those with open surgery, said Dr. Hendrik Jaap Bonjer of VU University Medical Center, Amsterdam, and his associates.

They now report the 3-year outcomes of the Colorectal Cancer Laparoscopic or Open Resection (COLOR) II trial, an industry-sponsored noninferiority study performed at 30 medical centers in eight countries in Europe, North America, and Asia. The trial involved 1,044 patients who had solitary, noninvasive adenocarcinomas of the rectum within 15 cm of the anal verge. A total of 699 of the study participants were randomly assigned to laparoscopic and 345 to open surgery.

At 3-year follow-up, the rate of locoregional recurrence was identical between the two study groups, at 5% each. In addition, rates of disease-free survival slightly favored the laparoscopic approach (74.8%) over the open approach (70.8%), as did rates of overall survival (86.7% and 83.6%, respectively) and rates of distant metastases (19.1% and 22.1%, respectively). Patients with stage III disease appeared to benefit the most from laparoscopic surgery, with disease-free survival of 64.9% vs. 52.0%, the investigators said (N. Engl. J. Med. 2015 April 1 [doi:10.1056/NEJMoa1414882]). These findings support the idea that the reduced surgical trauma associated with laparoscopic techniques may decrease tumor recurrence, perhaps by attenuating stress responses and preserving immune function, they noted.

“In our study, laparoscopic surgery in patients with cancer in the lower third of the rectum was associated with a lower rate of involved circumferential resection margin and a lower locoregional recurrence rate than was open surgery. During laparoscopic surgery, narrow spaces such as the lower pelvis are better visualized than in open surgery, owing to the use of a laparoscope, which projects a magnified and well-illuminated image of the operative field on the monitors. A clear view is of paramount importance to accomplish a resection of the cancer with sufficient margins,” Dr. Bonjer and his associates added.

The trial was funded by Ethicon Endo-Surgery Europe, a subsidiary of Johnson & Johnson; the Swedish Cancer Society; the Health and Medical Care Committee of Region Vastra Gotaland; Sahlgrenska University Hospital; Erasmus University Medical Center; Dahousie University; and VU University Medical Center. Dr. Bonjer reported having no disclosures; two of his associates reported ties to AbbVie, Merck Sharp & Dohme, Takeda, Johnson & Johnson, Covidien, Olympus Medical, and Applied Medical.

A mixture of eight probiotic bacterial strains only somewhat outperformed placebo for preventing endoscopic recurrence after ileal resection in Crohn’s disease patients, according to a multicenter, randomized trial.

After 90 days of treatment, 9.3% of patients who received the probiotic mixture (VSL#3) had developed severe endoscopic recurrence, compared with 15.7% of the placebo group (P = .19), reported Dr. Richard Fedorak of the University of Alberta, Edmonton, and his associates.

The recurrence rate for the placebo group was about two-thirds lower than what the researchers had expected based on the sample size calculation, they noted. But the probiotic blend was linked to significantly significant decreases in colonic mucosal levels of proinflammatory cytokines, they reported (Clin. Gastroenterol. Hepatol. 2014 Nov. 6 [doi:10.1016/j.cgh.2014.10.031]).

Investigators have tested probiotics as a preventive therapy for Crohn’s disease because patients with active disease have less diverse intestinal microbiota, compared with those with quiescent disease or healthy controls. Past studies of single-strain probiotics have shown them to be no better than placebo for preventing endoscopic recurrence.

But in one small study, rifampin followed by VSL#3 outperformed mesalamine at 1 year (Gastroenterology 2000;118:A781), the researchers noted. “This mixture could confer protective effects where single-strain or lactobacillus-only formulations had failed,” they hypothesized.

To test that theory, the investigators randomized 120 patients with Crohn’s disease who had undergone ileal resection and ileocolonic anastomosis to twice-daily VSL#3 or placebo. Treatment began within 30 days after surgery and continued for 90 days, after which all patients received open-label VSL#3 for another 9 months.

Among patients who had nonsevere endoscopic lesions at day 90, 1-year rates of severe endoscopic recurrence were 10% for the early VSL#3 group, compared with 26.7% for the late VSL#3 group (P = .09), said the researchers. Likewise, combined rates of severe recurrence on days 90 and 365 were not statistically different, they reported. However, the early VSL#3 group had lower mucosal levels of 13 pro-inflammatory cytokines, compared with patients who received placebo until day 90 (P < .05). Measures of Crohn’s disease activity and disease-related quality of life scores were similar for both groups.

“Early treatment with VSL#3 had a larger effect than late treatment,” concluded the investigators. “Future larger studies will be needed to confirm the effect of VSL#3 in prevention of postoperative recurrence.”

The study was funded by VSL Pharmaceuticals, the Canadian Institutes of Health Research, and Crohn’s and Colitis Foundation of Canada. Dr. Fedorak reported having served on a speakers bureau for VSL Pharmaceuticals. The other authors declared no relevant conflicts of interest.

A mixture of eight probiotic bacterial strains only somewhat outperformed placebo for preventing endoscopic recurrence after ileal resection in Crohn’s disease patients, according to a multicenter, randomized trial.

After 90 days of treatment, 9.3% of patients who received the probiotic mixture (VSL#3) had developed severe endoscopic recurrence, compared with 15.7% of the placebo group (P = .19), reported Dr. Richard Fedorak of the University of Alberta, Edmonton, and his associates.

The recurrence rate for the placebo group was about two-thirds lower than what the researchers had expected based on the sample size calculation, they noted. But the probiotic blend was linked to significantly significant decreases in colonic mucosal levels of proinflammatory cytokines, they reported (Clin. Gastroenterol. Hepatol. 2014 Nov. 6 [doi:10.1016/j.cgh.2014.10.031]).

Investigators have tested probiotics as a preventive therapy for Crohn’s disease because patients with active disease have less diverse intestinal microbiota, compared with those with quiescent disease or healthy controls. Past studies of single-strain probiotics have shown them to be no better than placebo for preventing endoscopic recurrence.

But in one small study, rifampin followed by VSL#3 outperformed mesalamine at 1 year (Gastroenterology 2000;118:A781), the researchers noted. “This mixture could confer protective effects where single-strain or lactobacillus-only formulations had failed,” they hypothesized.

To test that theory, the investigators randomized 120 patients with Crohn’s disease who had undergone ileal resection and ileocolonic anastomosis to twice-daily VSL#3 or placebo. Treatment began within 30 days after surgery and continued for 90 days, after which all patients received open-label VSL#3 for another 9 months.

Among patients who had nonsevere endoscopic lesions at day 90, 1-year rates of severe endoscopic recurrence were 10% for the early VSL#3 group, compared with 26.7% for the late VSL#3 group (P = .09), said the researchers. Likewise, combined rates of severe recurrence on days 90 and 365 were not statistically different, they reported. However, the early VSL#3 group had lower mucosal levels of 13 pro-inflammatory cytokines, compared with patients who received placebo until day 90 (P < .05). Measures of Crohn’s disease activity and disease-related quality of life scores were similar for both groups.

“Early treatment with VSL#3 had a larger effect than late treatment,” concluded the investigators. “Future larger studies will be needed to confirm the effect of VSL#3 in prevention of postoperative recurrence.”

The study was funded by VSL Pharmaceuticals, the Canadian Institutes of Health Research, and Crohn’s and Colitis Foundation of Canada. Dr. Fedorak reported having served on a speakers bureau for VSL Pharmaceuticals. The other authors declared no relevant conflicts of interest.

A mixture of eight probiotic bacterial strains only somewhat outperformed placebo for preventing endoscopic recurrence after ileal resection in Crohn’s disease patients, according to a multicenter, randomized trial.

After 90 days of treatment, 9.3% of patients who received the probiotic mixture (VSL#3) had developed severe endoscopic recurrence, compared with 15.7% of the placebo group (P = .19), reported Dr. Richard Fedorak of the University of Alberta, Edmonton, and his associates.

The recurrence rate for the placebo group was about two-thirds lower than what the researchers had expected based on the sample size calculation, they noted. But the probiotic blend was linked to significantly significant decreases in colonic mucosal levels of proinflammatory cytokines, they reported (Clin. Gastroenterol. Hepatol. 2014 Nov. 6 [doi:10.1016/j.cgh.2014.10.031]).

Investigators have tested probiotics as a preventive therapy for Crohn’s disease because patients with active disease have less diverse intestinal microbiota, compared with those with quiescent disease or healthy controls. Past studies of single-strain probiotics have shown them to be no better than placebo for preventing endoscopic recurrence.

But in one small study, rifampin followed by VSL#3 outperformed mesalamine at 1 year (Gastroenterology 2000;118:A781), the researchers noted. “This mixture could confer protective effects where single-strain or lactobacillus-only formulations had failed,” they hypothesized.

To test that theory, the investigators randomized 120 patients with Crohn’s disease who had undergone ileal resection and ileocolonic anastomosis to twice-daily VSL#3 or placebo. Treatment began within 30 days after surgery and continued for 90 days, after which all patients received open-label VSL#3 for another 9 months.

Among patients who had nonsevere endoscopic lesions at day 90, 1-year rates of severe endoscopic recurrence were 10% for the early VSL#3 group, compared with 26.7% for the late VSL#3 group (P = .09), said the researchers. Likewise, combined rates of severe recurrence on days 90 and 365 were not statistically different, they reported. However, the early VSL#3 group had lower mucosal levels of 13 pro-inflammatory cytokines, compared with patients who received placebo until day 90 (P < .05). Measures of Crohn’s disease activity and disease-related quality of life scores were similar for both groups.

“Early treatment with VSL#3 had a larger effect than late treatment,” concluded the investigators. “Future larger studies will be needed to confirm the effect of VSL#3 in prevention of postoperative recurrence.”

The study was funded by VSL Pharmaceuticals, the Canadian Institutes of Health Research, and Crohn’s and Colitis Foundation of Canada. Dr. Fedorak reported having served on a speakers bureau for VSL Pharmaceuticals. The other authors declared no relevant conflicts of interest.

CHICAGO – A nationwide analysis comparing straight versus hand-assisted laparoscopic colectomy appears to have resulted in a draw.

Despite being used more commonly in patients with higher body mass index and comorbidities, hand-assisted laparoscopic surgery (HALS) resulted in a significantly shorter operative time than did straight laparoscopic surgery (LAP) (171 minutes vs. 178.8 minutes; P < .001).

On the other hand, LAP was associated with a significantly shorter length of stay (5.9 days vs. 6.0 days; P < .001), fewer complications (15.9% vs. 18.2%; P = .006), fewer specifically superficial skin infections (4.1% vs. 5.4%; P = .007), and less prolonged postoperative ileus (7.5% vs. 9.1%; P = .01).

The differences were statistically significant likely because of the high volume of patients in each group, but are unlikely to be clinically significant in terms of patient care, senior study author Dr. I. Emre Gorgun said at the annual meeting of the Central Surgical Association.

Patrice Wendling/Frontline Medical News

CSA incoming president Dr. Scott A. Gruber, chief of staff at the John D. Dingell VA Medical Center in Detroit, agreed. “There were very, very small differences. I think they were trying to show that the two [approaches] are virtually equivalent,” he said in an interview. “Each has its advantages and disadvantages, but the HALS technique was used in more complex, more high-risk patients,” Dr. Gruber said.

HALS bridges the learning gap between open and straight laparoscopic surgery, which has been slow to gain adoption in colorectal surgery because it is technically demanding and has a steep learning curve, said Dr. Gorgun, a colorectal surgeon at the Cleveland Clinic. HALS allows surgeons to regain tactile sensation and manual retraction, enabling them to perform even more complex operations more effectively.

Studies also suggest that HALS reduces conversion rates and preserves the short-term benefits of LAP, though a nationwide comparison of short-term outcomes using the two techniques has been absent.

To fill this knowledge gap, the investigators used the 2012 colectomy-targeted American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP

Courtesy Applied Medical

At baseline, the HALS group was significantly older than the LAP group (61.5 years vs. 60 years), had a higher body mass index (28.6 kg/m2 vs. 28 kg/m2), was more likely to be hypertensive (49.8% vs. 45.1%), and to be American Society of Anesthesiologists class III (42% vs. 37.4%) and class IV (2.8% vs. 2.7%). Steroid use for inflammatory bowel disease was significantly higher in the LAP group (6.5% vs. 5.4%).

Mortality rates were similar in the LAP and HALS groups (0.52% vs. 0.50%; P = .94), Dr. Gorgun reported.

Multivariate logistic regression adjusted for comorbid conditions lessened the degree of differences between the two groups, but continued to favor HALS for shorter operative time (odds ratio, 0.94) and favor LAP for shorter hospital stays (OR, 1.05) and less superficial surgical site infections (OR, 1.31), less prolonged post-operative ileus (OR, 1.25), and overall morbidity (OR, 1.16).

“Both LAP and HALS approaches are used in minimally invasive colorectal surgery based on their respective contributions and complement each other,” Dr. Gorgun concluded. “Implementing the best approach to decrease postoperative complication rates and increase use of MIS [minimally invasive surgery] will play a role in improving patient care and overall quality of health care.”

Dr. Gorgun, his coauthors, and Dr. Gruber reported having no financial conflicts

[email protected]

CHICAGO – A nationwide analysis comparing straight versus hand-assisted laparoscopic colectomy appears to have resulted in a draw.

Despite being used more commonly in patients with higher body mass index and comorbidities, hand-assisted laparoscopic surgery (HALS) resulted in a significantly shorter operative time than did straight laparoscopic surgery (LAP) (171 minutes vs. 178.8 minutes; P < .001).

On the other hand, LAP was associated with a significantly shorter length of stay (5.9 days vs. 6.0 days; P < .001), fewer complications (15.9% vs. 18.2%; P = .006), fewer specifically superficial skin infections (4.1% vs. 5.4%; P = .007), and less prolonged postoperative ileus (7.5% vs. 9.1%; P = .01).

The differences were statistically significant likely because of the high volume of patients in each group, but are unlikely to be clinically significant in terms of patient care, senior study author Dr. I. Emre Gorgun said at the annual meeting of the Central Surgical Association.

Patrice Wendling/Frontline Medical News

CSA incoming president Dr. Scott A. Gruber, chief of staff at the John D. Dingell VA Medical Center in Detroit, agreed. “There were very, very small differences. I think they were trying to show that the two [approaches] are virtually equivalent,” he said in an interview. “Each has its advantages and disadvantages, but the HALS technique was used in more complex, more high-risk patients,” Dr. Gruber said.

HALS bridges the learning gap between open and straight laparoscopic surgery, which has been slow to gain adoption in colorectal surgery because it is technically demanding and has a steep learning curve, said Dr. Gorgun, a colorectal surgeon at the Cleveland Clinic. HALS allows surgeons to regain tactile sensation and manual retraction, enabling them to perform even more complex operations more effectively.

Studies also suggest that HALS reduces conversion rates and preserves the short-term benefits of LAP, though a nationwide comparison of short-term outcomes using the two techniques has been absent.

To fill this knowledge gap, the investigators used the 2012 colectomy-targeted American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP

Courtesy Applied Medical

At baseline, the HALS group was significantly older than the LAP group (61.5 years vs. 60 years), had a higher body mass index (28.6 kg/m2 vs. 28 kg/m2), was more likely to be hypertensive (49.8% vs. 45.1%), and to be American Society of Anesthesiologists class III (42% vs. 37.4%) and class IV (2.8% vs. 2.7%). Steroid use for inflammatory bowel disease was significantly higher in the LAP group (6.5% vs. 5.4%).

Mortality rates were similar in the LAP and HALS groups (0.52% vs. 0.50%; P = .94), Dr. Gorgun reported.

Multivariate logistic regression adjusted for comorbid conditions lessened the degree of differences between the two groups, but continued to favor HALS for shorter operative time (odds ratio, 0.94) and favor LAP for shorter hospital stays (OR, 1.05) and less superficial surgical site infections (OR, 1.31), less prolonged post-operative ileus (OR, 1.25), and overall morbidity (OR, 1.16).

“Both LAP and HALS approaches are used in minimally invasive colorectal surgery based on their respective contributions and complement each other,” Dr. Gorgun concluded. “Implementing the best approach to decrease postoperative complication rates and increase use of MIS [minimally invasive surgery] will play a role in improving patient care and overall quality of health care.”

Dr. Gorgun, his coauthors, and Dr. Gruber reported having no financial conflicts

[email protected]

CHICAGO – A nationwide analysis comparing straight versus hand-assisted laparoscopic colectomy appears to have resulted in a draw.

Despite being used more commonly in patients with higher body mass index and comorbidities, hand-assisted laparoscopic surgery (HALS) resulted in a significantly shorter operative time than did straight laparoscopic surgery (LAP) (171 minutes vs. 178.8 minutes; P < .001).

On the other hand, LAP was associated with a significantly shorter length of stay (5.9 days vs. 6.0 days; P < .001), fewer complications (15.9% vs. 18.2%; P = .006), fewer specifically superficial skin infections (4.1% vs. 5.4%; P = .007), and less prolonged postoperative ileus (7.5% vs. 9.1%; P = .01).

The differences were statistically significant likely because of the high volume of patients in each group, but are unlikely to be clinically significant in terms of patient care, senior study author Dr. I. Emre Gorgun said at the annual meeting of the Central Surgical Association.

Patrice Wendling/Frontline Medical News

CSA incoming president Dr. Scott A. Gruber, chief of staff at the John D. Dingell VA Medical Center in Detroit, agreed. “There were very, very small differences. I think they were trying to show that the two [approaches] are virtually equivalent,” he said in an interview. “Each has its advantages and disadvantages, but the HALS technique was used in more complex, more high-risk patients,” Dr. Gruber said.

HALS bridges the learning gap between open and straight laparoscopic surgery, which has been slow to gain adoption in colorectal surgery because it is technically demanding and has a steep learning curve, said Dr. Gorgun, a colorectal surgeon at the Cleveland Clinic. HALS allows surgeons to regain tactile sensation and manual retraction, enabling them to perform even more complex operations more effectively.

Studies also suggest that HALS reduces conversion rates and preserves the short-term benefits of LAP, though a nationwide comparison of short-term outcomes using the two techniques has been absent.

To fill this knowledge gap, the investigators used the 2012 colectomy-targeted American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP

Courtesy Applied Medical

At baseline, the HALS group was significantly older than the LAP group (61.5 years vs. 60 years), had a higher body mass index (28.6 kg/m2 vs. 28 kg/m2), was more likely to be hypertensive (49.8% vs. 45.1%), and to be American Society of Anesthesiologists class III (42% vs. 37.4%) and class IV (2.8% vs. 2.7%). Steroid use for inflammatory bowel disease was significantly higher in the LAP group (6.5% vs. 5.4%).

Mortality rates were similar in the LAP and HALS groups (0.52% vs. 0.50%; P = .94), Dr. Gorgun reported.

Multivariate logistic regression adjusted for comorbid conditions lessened the degree of differences between the two groups, but continued to favor HALS for shorter operative time (odds ratio, 0.94) and favor LAP for shorter hospital stays (OR, 1.05) and less superficial surgical site infections (OR, 1.31), less prolonged post-operative ileus (OR, 1.25), and overall morbidity (OR, 1.16).

“Both LAP and HALS approaches are used in minimally invasive colorectal surgery based on their respective contributions and complement each other,” Dr. Gorgun concluded. “Implementing the best approach to decrease postoperative complication rates and increase use of MIS [minimally invasive surgery] will play a role in improving patient care and overall quality of health care.”

Dr. Gorgun, his coauthors, and Dr. Gruber reported having no financial conflicts

[email protected]

According to the CDC, colorectal cancer (CRC) is largely preventable but remains the second leading cancer killer for men and women in the U.S. Screening for polyps (detection of abnormal growths) and surveillance (based on prior bowel preparation quality, findings, and personal and family histories) are key elements for CRC prevention and survival.¹ However, inadequate bowel preparation greatly reduces accuracy of its intended purpose: finding and removing precancerous polyps or lesions before they develop into a cancer, typically within a 10-year window. If preparation quality is not satisfactory, the ability of the endoscopist to meet national polyp detection rates is limited. These rates are currently 25% for men and 15% for women.² Compounding poor preparation, many veterans avoid CRC screening due to anxiety, shame, and fear of what could be found.

Related: Do I Need a Colonoscopy?

About 60% of veterans presenting for colonoscopy have inadequate bowel preparation.³ Colonoscopy remains the gold standard for detection of colorectal pathology and is available to veterans without insurance preauthorization, eliminating a significant barrier to screening.¹ Inadequate bowel preparation can result in missed polyps, cancelled procedures, and increased procedure time. Nonadherence to the liquid diet and high-volume, bowel-cleansing solution can lead to a repeated colonoscopy.

Two nurse practitioners (NPs) at the Philadelphia VAMC (PVAMC) gastroenterology (GE) section recognized that many veterans had poor bowel preparation in spite of preprocedure visits, written instructions, and no financial limitations. Repeated colonoscopies were impacting patient satisfaction, facility costs, and endoscopy staff morale. The NPs developed a study to examine bowel preparation outcomes after a group preprocedure class that provided comprehensive and multimedia education in comparison to standard mailed instructions. The study was approved by the Institutional Review Board. The hypothesis was that group patient education would result in better adherence to bowel preparation instructions than did mailed instructions and that better adherence would result in significantly improved colonoscopy outcomes.

Methods

This was a descriptive pilot study with a convenience sample of 200 veterans randomly selected between 2009 and 2011. The study measured 2 groups. The control group received only the mailed standard bowel preparation instructions, whereas the intervention group received the standard bowel preparation instructions and participated in a group intervention class. Eligible participants were aged 45 to 79 years and were enrolled as patients in a single center (PVAMC GE clinic).

Related: E-Consults in Gastroenterology: A Quality Improvement Project

After referral consults were initially selected for appropriate colonoscopy screening or surveillance, potential patient subjects were randomized into either the control or intervention groups by the coin toss method, followed by mailed letters inviting them to participate in the study. If subjects expressed interest, then consent was obtained. The colonoscopy procedure note was updated to reflect bowel preparation quality. All subjects were de-identified. There were about 8 endoscopists; all were board-certified gastroenterologists plus GE fellows who performed procedures at the time of the study. (Fellows rotated every 2 to 4 weeks in the GE clinic and were always accompanied by an attending gastroenterologist.)

All the endoscopists were instructed in the grading system adapted from the modified Aronchick scale (Table 1).⁴ This scale measures the quality of bowel preparation for the entire colon: excellent (> 95% visualization of bowel mucosa); good (> 90% of mucosa was visible); fair (some semisolid stool could be suctioned out, but > 90% of mucosa was visible), and poor (semisolid stool cannot be suctioned out and < 90% of mucosa was seen). The modified Aronchick scale also has an inadequate rating, but this was not used in the study. For this study, bowel preparation that was excellent or good received a 1, a fair preparation received a 2, and poor preparation received a 3. The Pearson correlation for the modified Aronchick scale coefficients was 0.62 (P < .001). The value for the kappa statistic was 0.77 (P < .001).⁵

Results

There were 77 men and 5 women enrolled in the study. The control group had 43 subjects, and the intervention group had 39 subjects. Only 28 subjects each from the control and intervention groups had the quality of bowel preparation rated by the endoscopists. In the control group, 53.6% were rated excellent or good, 42.9% were fair, and 3.5% were poor. In the intervention group, 42.9 % of preparations were excellent or good, 42.8% were fair, and 14.3% were poor (Table 2).

Preparation quality was not described in the procedure documentation for 34.9% and 28.2% of the subjects, respectively, for the control and intervention groups. There was no significant difference in no-show rates to procedures in either of the groups. Based on the data, a Fisher exact test for association was performed (P = .39), indicating there was no evidence of association between the intervention group and preparation quality.

The authors observed several recurrent themes during the group interventions. Fear of finding cancer and the perception of the procedure’s invasiveness were raised and addressed. Also misconceptions about CRC were debunked, such as the belief that a lack of bowel symptoms indicated no chance of having CRC or that only a family history indicated a risk factor. Patients discussed how much they learned about CRC, colon anatomy, and the importance of the bowel preparation. A multifaceted teaching approach was used to convey teaching points, such as flip charts, colonoscopy equipment, tours of procedure rooms, and visuals of various bowel preparation qualities. Throughout the educational intervention, humor, active listening, and reflection were woven into discussions to create a comfortable and relaxed learning environment.

Discussion and Limitations

The study results were unexpected. The authors had hypothesized that the group preprocedure educational intervention would have made a statistically significant difference in preparation quality, but it did not. In addition, the authors’ observations during the intervention led them to believe that the subjects had gained knowledge about how to correctly administer the bowel preparation.

Related: Do Age and Gender Matter in Colorectal Cancer?

A significant limitation of this pilot study was the difficulty in extrapolating meaningful data within the intervention group and between the intervention and control groups. After closely examining the raw data, the authors identified some key issues: There were only 28 subjects in each group who had bowel preparation quality described. This small sample size makes it difficult to draw meaningful conclusions. However, the education session in and of itself was clearly a positive experience for subjects, and the authors would recommend a future study with a larger sample size.

A prior power analysis would have helped this study determine a sufficient number of subjects that would be needed to determine whether the intervention had an effect. Furthermore, instead of tossing a coin to randomize the study groups, other types of randomization could have been used.

Other study limitations that came to light were:

Since the study, the authors have learned more about changes in national standards for bowel preparation administration and polyp surveillance. Preparation instructions need to be updated to reflect current recommendations for split-dose preparation administration in which the bowel preparation is taken in spaced doses, leading to better compliance and outcomes.⁶ Informally, patients and family have told staff that preparation instructions are difficult to understand. Following a Plan-Do-Study-Act cycle, feedback from patients should be obtained before revising and printing preparation instructions.⁷ This feedback could ensure that preparation instructions are written in patient-friendly, easily understood language.

Conclusion

Nursing professionals are likely to be effective in helping veterans achieve improved bowel preparation quality, because nurses have an established record as patient educators and advocates. Good bowel preparation quality is an important, achievable objective for veterans. As Mangnall reported, bowel preparation quality data are a strong nurse-sensitive quality measure that can be used to devise more effective interventions to obtain better bowel preparation results.⁸ As clinicians working on the frontline, nurses are well positioned to assess, intervene, and evaluate whether or not the modifications they have made to bowel preparation instructions are effective as they measure bowel preparation quality status post colonoscopy.

Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

According to the CDC, colorectal cancer (CRC) is largely preventable but remains the second leading cancer killer for men and women in the U.S. Screening for polyps (detection of abnormal growths) and surveillance (based on prior bowel preparation quality, findings, and personal and family histories) are key elements for CRC prevention and survival.¹ However, inadequate bowel preparation greatly reduces accuracy of its intended purpose: finding and removing precancerous polyps or lesions before they develop into a cancer, typically within a 10-year window. If preparation quality is not satisfactory, the ability of the endoscopist to meet national polyp detection rates is limited. These rates are currently 25% for men and 15% for women.² Compounding poor preparation, many veterans avoid CRC screening due to anxiety, shame, and fear of what could be found.

Related: Do I Need a Colonoscopy?

About 60% of veterans presenting for colonoscopy have inadequate bowel preparation.³ Colonoscopy remains the gold standard for detection of colorectal pathology and is available to veterans without insurance preauthorization, eliminating a significant barrier to screening.¹ Inadequate bowel preparation can result in missed polyps, cancelled procedures, and increased procedure time. Nonadherence to the liquid diet and high-volume, bowel-cleansing solution can lead to a repeated colonoscopy.

Two nurse practitioners (NPs) at the Philadelphia VAMC (PVAMC) gastroenterology (GE) section recognized that many veterans had poor bowel preparation in spite of preprocedure visits, written instructions, and no financial limitations. Repeated colonoscopies were impacting patient satisfaction, facility costs, and endoscopy staff morale. The NPs developed a study to examine bowel preparation outcomes after a group preprocedure class that provided comprehensive and multimedia education in comparison to standard mailed instructions. The study was approved by the Institutional Review Board. The hypothesis was that group patient education would result in better adherence to bowel preparation instructions than did mailed instructions and that better adherence would result in significantly improved colonoscopy outcomes.

Methods

This was a descriptive pilot study with a convenience sample of 200 veterans randomly selected between 2009 and 2011. The study measured 2 groups. The control group received only the mailed standard bowel preparation instructions, whereas the intervention group received the standard bowel preparation instructions and participated in a group intervention class. Eligible participants were aged 45 to 79 years and were enrolled as patients in a single center (PVAMC GE clinic).

Related: E-Consults in Gastroenterology: A Quality Improvement Project

After referral consults were initially selected for appropriate colonoscopy screening or surveillance, potential patient subjects were randomized into either the control or intervention groups by the coin toss method, followed by mailed letters inviting them to participate in the study. If subjects expressed interest, then consent was obtained. The colonoscopy procedure note was updated to reflect bowel preparation quality. All subjects were de-identified. There were about 8 endoscopists; all were board-certified gastroenterologists plus GE fellows who performed procedures at the time of the study. (Fellows rotated every 2 to 4 weeks in the GE clinic and were always accompanied by an attending gastroenterologist.)

All the endoscopists were instructed in the grading system adapted from the modified Aronchick scale (Table 1).⁴ This scale measures the quality of bowel preparation for the entire colon: excellent (> 95% visualization of bowel mucosa); good (> 90% of mucosa was visible); fair (some semisolid stool could be suctioned out, but > 90% of mucosa was visible), and poor (semisolid stool cannot be suctioned out and < 90% of mucosa was seen). The modified Aronchick scale also has an inadequate rating, but this was not used in the study. For this study, bowel preparation that was excellent or good received a 1, a fair preparation received a 2, and poor preparation received a 3. The Pearson correlation for the modified Aronchick scale coefficients was 0.62 (P < .001). The value for the kappa statistic was 0.77 (P < .001).⁵

Results

There were 77 men and 5 women enrolled in the study. The control group had 43 subjects, and the intervention group had 39 subjects. Only 28 subjects each from the control and intervention groups had the quality of bowel preparation rated by the endoscopists. In the control group, 53.6% were rated excellent or good, 42.9% were fair, and 3.5% were poor. In the intervention group, 42.9 % of preparations were excellent or good, 42.8% were fair, and 14.3% were poor (Table 2).

Preparation quality was not described in the procedure documentation for 34.9% and 28.2% of the subjects, respectively, for the control and intervention groups. There was no significant difference in no-show rates to procedures in either of the groups. Based on the data, a Fisher exact test for association was performed (P = .39), indicating there was no evidence of association between the intervention group and preparation quality.

The authors observed several recurrent themes during the group interventions. Fear of finding cancer and the perception of the procedure’s invasiveness were raised and addressed. Also misconceptions about CRC were debunked, such as the belief that a lack of bowel symptoms indicated no chance of having CRC or that only a family history indicated a risk factor. Patients discussed how much they learned about CRC, colon anatomy, and the importance of the bowel preparation. A multifaceted teaching approach was used to convey teaching points, such as flip charts, colonoscopy equipment, tours of procedure rooms, and visuals of various bowel preparation qualities. Throughout the educational intervention, humor, active listening, and reflection were woven into discussions to create a comfortable and relaxed learning environment.

Discussion and Limitations

The study results were unexpected. The authors had hypothesized that the group preprocedure educational intervention would have made a statistically significant difference in preparation quality, but it did not. In addition, the authors’ observations during the intervention led them to believe that the subjects had gained knowledge about how to correctly administer the bowel preparation.

Related: Do Age and Gender Matter in Colorectal Cancer?

A significant limitation of this pilot study was the difficulty in extrapolating meaningful data within the intervention group and between the intervention and control groups. After closely examining the raw data, the authors identified some key issues: There were only 28 subjects in each group who had bowel preparation quality described. This small sample size makes it difficult to draw meaningful conclusions. However, the education session in and of itself was clearly a positive experience for subjects, and the authors would recommend a future study with a larger sample size.

A prior power analysis would have helped this study determine a sufficient number of subjects that would be needed to determine whether the intervention had an effect. Furthermore, instead of tossing a coin to randomize the study groups, other types of randomization could have been used.

Other study limitations that came to light were:

Since the study, the authors have learned more about changes in national standards for bowel preparation administration and polyp surveillance. Preparation instructions need to be updated to reflect current recommendations for split-dose preparation administration in which the bowel preparation is taken in spaced doses, leading to better compliance and outcomes.⁶ Informally, patients and family have told staff that preparation instructions are difficult to understand. Following a Plan-Do-Study-Act cycle, feedback from patients should be obtained before revising and printing preparation instructions.⁷ This feedback could ensure that preparation instructions are written in patient-friendly, easily understood language.

Conclusion

Nursing professionals are likely to be effective in helping veterans achieve improved bowel preparation quality, because nurses have an established record as patient educators and advocates. Good bowel preparation quality is an important, achievable objective for veterans. As Mangnall reported, bowel preparation quality data are a strong nurse-sensitive quality measure that can be used to devise more effective interventions to obtain better bowel preparation results.⁸ As clinicians working on the frontline, nurses are well positioned to assess, intervene, and evaluate whether or not the modifications they have made to bowel preparation instructions are effective as they measure bowel preparation quality status post colonoscopy.

Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

According to the CDC, colorectal cancer (CRC) is largely preventable but remains the second leading cancer killer for men and women in the U.S. Screening for polyps (detection of abnormal growths) and surveillance (based on prior bowel preparation quality, findings, and personal and family histories) are key elements for CRC prevention and survival.¹ However, inadequate bowel preparation greatly reduces accuracy of its intended purpose: finding and removing precancerous polyps or lesions before they develop into a cancer, typically within a 10-year window. If preparation quality is not satisfactory, the ability of the endoscopist to meet national polyp detection rates is limited. These rates are currently 25% for men and 15% for women.² Compounding poor preparation, many veterans avoid CRC screening due to anxiety, shame, and fear of what could be found.

Related: Do I Need a Colonoscopy?

About 60% of veterans presenting for colonoscopy have inadequate bowel preparation.³ Colonoscopy remains the gold standard for detection of colorectal pathology and is available to veterans without insurance preauthorization, eliminating a significant barrier to screening.¹ Inadequate bowel preparation can result in missed polyps, cancelled procedures, and increased procedure time. Nonadherence to the liquid diet and high-volume, bowel-cleansing solution can lead to a repeated colonoscopy.

Two nurse practitioners (NPs) at the Philadelphia VAMC (PVAMC) gastroenterology (GE) section recognized that many veterans had poor bowel preparation in spite of preprocedure visits, written instructions, and no financial limitations. Repeated colonoscopies were impacting patient satisfaction, facility costs, and endoscopy staff morale. The NPs developed a study to examine bowel preparation outcomes after a group preprocedure class that provided comprehensive and multimedia education in comparison to standard mailed instructions. The study was approved by the Institutional Review Board. The hypothesis was that group patient education would result in better adherence to bowel preparation instructions than did mailed instructions and that better adherence would result in significantly improved colonoscopy outcomes.

Methods

This was a descriptive pilot study with a convenience sample of 200 veterans randomly selected between 2009 and 2011. The study measured 2 groups. The control group received only the mailed standard bowel preparation instructions, whereas the intervention group received the standard bowel preparation instructions and participated in a group intervention class. Eligible participants were aged 45 to 79 years and were enrolled as patients in a single center (PVAMC GE clinic).

Related: E-Consults in Gastroenterology: A Quality Improvement Project

After referral consults were initially selected for appropriate colonoscopy screening or surveillance, potential patient subjects were randomized into either the control or intervention groups by the coin toss method, followed by mailed letters inviting them to participate in the study. If subjects expressed interest, then consent was obtained. The colonoscopy procedure note was updated to reflect bowel preparation quality. All subjects were de-identified. There were about 8 endoscopists; all were board-certified gastroenterologists plus GE fellows who performed procedures at the time of the study. (Fellows rotated every 2 to 4 weeks in the GE clinic and were always accompanied by an attending gastroenterologist.)

All the endoscopists were instructed in the grading system adapted from the modified Aronchick scale (Table 1).⁴ This scale measures the quality of bowel preparation for the entire colon: excellent (> 95% visualization of bowel mucosa); good (> 90% of mucosa was visible); fair (some semisolid stool could be suctioned out, but > 90% of mucosa was visible), and poor (semisolid stool cannot be suctioned out and < 90% of mucosa was seen). The modified Aronchick scale also has an inadequate rating, but this was not used in the study. For this study, bowel preparation that was excellent or good received a 1, a fair preparation received a 2, and poor preparation received a 3. The Pearson correlation for the modified Aronchick scale coefficients was 0.62 (P < .001). The value for the kappa statistic was 0.77 (P < .001).⁵

Results

There were 77 men and 5 women enrolled in the study. The control group had 43 subjects, and the intervention group had 39 subjects. Only 28 subjects each from the control and intervention groups had the quality of bowel preparation rated by the endoscopists. In the control group, 53.6% were rated excellent or good, 42.9% were fair, and 3.5% were poor. In the intervention group, 42.9 % of preparations were excellent or good, 42.8% were fair, and 14.3% were poor (Table 2).

Preparation quality was not described in the procedure documentation for 34.9% and 28.2% of the subjects, respectively, for the control and intervention groups. There was no significant difference in no-show rates to procedures in either of the groups. Based on the data, a Fisher exact test for association was performed (P = .39), indicating there was no evidence of association between the intervention group and preparation quality.

The authors observed several recurrent themes during the group interventions. Fear of finding cancer and the perception of the procedure’s invasiveness were raised and addressed. Also misconceptions about CRC were debunked, such as the belief that a lack of bowel symptoms indicated no chance of having CRC or that only a family history indicated a risk factor. Patients discussed how much they learned about CRC, colon anatomy, and the importance of the bowel preparation. A multifaceted teaching approach was used to convey teaching points, such as flip charts, colonoscopy equipment, tours of procedure rooms, and visuals of various bowel preparation qualities. Throughout the educational intervention, humor, active listening, and reflection were woven into discussions to create a comfortable and relaxed learning environment.

Discussion and Limitations

The study results were unexpected. The authors had hypothesized that the group preprocedure educational intervention would have made a statistically significant difference in preparation quality, but it did not. In addition, the authors’ observations during the intervention led them to believe that the subjects had gained knowledge about how to correctly administer the bowel preparation.

Related: Do Age and Gender Matter in Colorectal Cancer?

A significant limitation of this pilot study was the difficulty in extrapolating meaningful data within the intervention group and between the intervention and control groups. After closely examining the raw data, the authors identified some key issues: There were only 28 subjects in each group who had bowel preparation quality described. This small sample size makes it difficult to draw meaningful conclusions. However, the education session in and of itself was clearly a positive experience for subjects, and the authors would recommend a future study with a larger sample size.

A prior power analysis would have helped this study determine a sufficient number of subjects that would be needed to determine whether the intervention had an effect. Furthermore, instead of tossing a coin to randomize the study groups, other types of randomization could have been used.

Other study limitations that came to light were:

Since the study, the authors have learned more about changes in national standards for bowel preparation administration and polyp surveillance. Preparation instructions need to be updated to reflect current recommendations for split-dose preparation administration in which the bowel preparation is taken in spaced doses, leading to better compliance and outcomes.⁶ Informally, patients and family have told staff that preparation instructions are difficult to understand. Following a Plan-Do-Study-Act cycle, feedback from patients should be obtained before revising and printing preparation instructions.⁷ This feedback could ensure that preparation instructions are written in patient-friendly, easily understood language.

Conclusion

Nursing professionals are likely to be effective in helping veterans achieve improved bowel preparation quality, because nurses have an established record as patient educators and advocates. Good bowel preparation quality is an important, achievable objective for veterans. As Mangnall reported, bowel preparation quality data are a strong nurse-sensitive quality measure that can be used to devise more effective interventions to obtain better bowel preparation results.⁸ As clinicians working on the frontline, nurses are well positioned to assess, intervene, and evaluate whether or not the modifications they have made to bowel preparation instructions are effective as they measure bowel preparation quality status post colonoscopy.

Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.