ACS Surgery News

For women with advanced epithelial ovarian cancer, aggressive cytoreductive surgery improves survival only if complete resection of disease is achieved. Aggressive debulking that achieves anything less than complete resection (R0) – even if the residual tumor is minimal (< 1 cm) – will not improve survival, according to a report published online Feb. 9 in Journal of Clinical Oncology.

“Over the last decade, there has been a growing trend toward more aggressive primary debulking surgery for women with epithelial ovarian cancer,” even though the impact of this approach on survival “has been unclear.” To examine the issue, researchers analyzed data from the multicenter Gynecologic Oncology Group-182 cohort, which they described as the largest clinical trial of ovarian cancer to date. They assessed survival outcomes in 2,655 patients who underwent aggressive cytoreductive surgery before receiving chemotherapy. The resection was complete (R0), in 32.4% of the women; it left minimal residual tumor (< 1 cm) in the remaining 67.6%, said Dr. Neil S. Horowitz of Brigham and Women’s Hospital, Boston, and his associates.

Both overall survival and progression-free survival were significantly improved when R0 was achieved, but not when there was minimal residual tumor. In the literature, as many as 25% of women who undergo aggressive surgical cytoreduction experience significant postoperative morbidity, and up to 2% fail to survive the procedure. These findings therefore “suggest that complex surgical procedures should be selectively used in patients with significant disease distribution and limited to those where only microscopic residual can be achieved,” the investigators said (J. Clin. Oncol. 2015 Feb. 9 [doi: 10.1200/JCO.2014.56.3106]).

“We suggest a potential paradigm shift, in which, if R0 is difficult to attain at primary cytoreduction, use of neoadjuvant chemotherapy with interval debulking to allow for R0 may be superior to primary surgery after which the patient is left with gross residual disease,” Dr. Horowitz and his associates added.

For women with advanced epithelial ovarian cancer, aggressive cytoreductive surgery improves survival only if complete resection of disease is achieved. Aggressive debulking that achieves anything less than complete resection (R0) – even if the residual tumor is minimal (< 1 cm) – will not improve survival, according to a report published online Feb. 9 in Journal of Clinical Oncology.

“Over the last decade, there has been a growing trend toward more aggressive primary debulking surgery for women with epithelial ovarian cancer,” even though the impact of this approach on survival “has been unclear.” To examine the issue, researchers analyzed data from the multicenter Gynecologic Oncology Group-182 cohort, which they described as the largest clinical trial of ovarian cancer to date. They assessed survival outcomes in 2,655 patients who underwent aggressive cytoreductive surgery before receiving chemotherapy. The resection was complete (R0), in 32.4% of the women; it left minimal residual tumor (< 1 cm) in the remaining 67.6%, said Dr. Neil S. Horowitz of Brigham and Women’s Hospital, Boston, and his associates.

Both overall survival and progression-free survival were significantly improved when R0 was achieved, but not when there was minimal residual tumor. In the literature, as many as 25% of women who undergo aggressive surgical cytoreduction experience significant postoperative morbidity, and up to 2% fail to survive the procedure. These findings therefore “suggest that complex surgical procedures should be selectively used in patients with significant disease distribution and limited to those where only microscopic residual can be achieved,” the investigators said (J. Clin. Oncol. 2015 Feb. 9 [doi: 10.1200/JCO.2014.56.3106]).

“We suggest a potential paradigm shift, in which, if R0 is difficult to attain at primary cytoreduction, use of neoadjuvant chemotherapy with interval debulking to allow for R0 may be superior to primary surgery after which the patient is left with gross residual disease,” Dr. Horowitz and his associates added.

For women with advanced epithelial ovarian cancer, aggressive cytoreductive surgery improves survival only if complete resection of disease is achieved. Aggressive debulking that achieves anything less than complete resection (R0) – even if the residual tumor is minimal (< 1 cm) – will not improve survival, according to a report published online Feb. 9 in Journal of Clinical Oncology.

“Over the last decade, there has been a growing trend toward more aggressive primary debulking surgery for women with epithelial ovarian cancer,” even though the impact of this approach on survival “has been unclear.” To examine the issue, researchers analyzed data from the multicenter Gynecologic Oncology Group-182 cohort, which they described as the largest clinical trial of ovarian cancer to date. They assessed survival outcomes in 2,655 patients who underwent aggressive cytoreductive surgery before receiving chemotherapy. The resection was complete (R0), in 32.4% of the women; it left minimal residual tumor (< 1 cm) in the remaining 67.6%, said Dr. Neil S. Horowitz of Brigham and Women’s Hospital, Boston, and his associates.

Both overall survival and progression-free survival were significantly improved when R0 was achieved, but not when there was minimal residual tumor. In the literature, as many as 25% of women who undergo aggressive surgical cytoreduction experience significant postoperative morbidity, and up to 2% fail to survive the procedure. These findings therefore “suggest that complex surgical procedures should be selectively used in patients with significant disease distribution and limited to those where only microscopic residual can be achieved,” the investigators said (J. Clin. Oncol. 2015 Feb. 9 [doi: 10.1200/JCO.2014.56.3106]).

“We suggest a potential paradigm shift, in which, if R0 is difficult to attain at primary cytoreduction, use of neoadjuvant chemotherapy with interval debulking to allow for R0 may be superior to primary surgery after which the patient is left with gross residual disease,” Dr. Horowitz and his associates added.

WASHINGTON – The transition to the ICD-10 coding set should take place as planned on Oct. 1, witnesses testified at a hearing of the House Energy and Commerce Committee’s Subcommittee on Health.

The message was welcome to committee leadership, who invited testimony almost solely from experts who support that position.

©Brian Jackson/iStockphoto.com

Subcommittee members from both sides of the aisle expressed a desire to not delay the implementation any further, though some at the Feb. 11 hearing questioned whether the Centers for Medicare & Medicaid Services was ready for the transition.

Subcommittee member Rep. Michael Burgess (R-Texas), an ob.gyn., said he had no questions about the readiness of Medicare contractors and insurance companies for the transition, but “all roads eventually lead to the Centers for Medicare & Medicaid Services. And if you will pardon me, that does appear to be a weak link in the chain because from HealthCare.gov to the Sunshine Act reporting website, when CMS flips a switch, something breaks.”

While no representative from the CMS testified, a recent report from the Government Accountability Office suggested that the agency is positioned to make the transition to ICD-10 by the Oct. 1 deadline, although continued testing is warranted. That report was commissioned by the Senate Finance Committee, which also expressed support for an Oct. 1 start date for ICD-10.

Kristi Matus, chief financial and administrative officer for Athenahealth, testified to the general readiness of the health IT community to make the switch to ICD-10. The government should either “maintain the current date for ICD-10 implementation or cancel it once and for all. Pull the trigger or pull the plug,” Ms. Matus said.

Dr. William J. Terry Sr., a urologist from Mobile, Ala., testified on behalf of the American Urological Association and expressed concern that not all physicians are ready. He suggested that a transition period might allow physicians and other providers to run ICD-9 and ICD-10 simultaneously to ensure that physicians do not inadvertently lose any payments because of coding errors that might occur as they learn the new system.

[email protected]

WASHINGTON – The transition to the ICD-10 coding set should take place as planned on Oct. 1, witnesses testified at a hearing of the House Energy and Commerce Committee’s Subcommittee on Health.

The message was welcome to committee leadership, who invited testimony almost solely from experts who support that position.

©Brian Jackson/iStockphoto.com

Subcommittee members from both sides of the aisle expressed a desire to not delay the implementation any further, though some at the Feb. 11 hearing questioned whether the Centers for Medicare & Medicaid Services was ready for the transition.

Subcommittee member Rep. Michael Burgess (R-Texas), an ob.gyn., said he had no questions about the readiness of Medicare contractors and insurance companies for the transition, but “all roads eventually lead to the Centers for Medicare & Medicaid Services. And if you will pardon me, that does appear to be a weak link in the chain because from HealthCare.gov to the Sunshine Act reporting website, when CMS flips a switch, something breaks.”

While no representative from the CMS testified, a recent report from the Government Accountability Office suggested that the agency is positioned to make the transition to ICD-10 by the Oct. 1 deadline, although continued testing is warranted. That report was commissioned by the Senate Finance Committee, which also expressed support for an Oct. 1 start date for ICD-10.

Kristi Matus, chief financial and administrative officer for Athenahealth, testified to the general readiness of the health IT community to make the switch to ICD-10. The government should either “maintain the current date for ICD-10 implementation or cancel it once and for all. Pull the trigger or pull the plug,” Ms. Matus said.

Dr. William J. Terry Sr., a urologist from Mobile, Ala., testified on behalf of the American Urological Association and expressed concern that not all physicians are ready. He suggested that a transition period might allow physicians and other providers to run ICD-9 and ICD-10 simultaneously to ensure that physicians do not inadvertently lose any payments because of coding errors that might occur as they learn the new system.

[email protected]

WASHINGTON – The transition to the ICD-10 coding set should take place as planned on Oct. 1, witnesses testified at a hearing of the House Energy and Commerce Committee’s Subcommittee on Health.

The message was welcome to committee leadership, who invited testimony almost solely from experts who support that position.

©Brian Jackson/iStockphoto.com

Subcommittee members from both sides of the aisle expressed a desire to not delay the implementation any further, though some at the Feb. 11 hearing questioned whether the Centers for Medicare & Medicaid Services was ready for the transition.

Subcommittee member Rep. Michael Burgess (R-Texas), an ob.gyn., said he had no questions about the readiness of Medicare contractors and insurance companies for the transition, but “all roads eventually lead to the Centers for Medicare & Medicaid Services. And if you will pardon me, that does appear to be a weak link in the chain because from HealthCare.gov to the Sunshine Act reporting website, when CMS flips a switch, something breaks.”

While no representative from the CMS testified, a recent report from the Government Accountability Office suggested that the agency is positioned to make the transition to ICD-10 by the Oct. 1 deadline, although continued testing is warranted. That report was commissioned by the Senate Finance Committee, which also expressed support for an Oct. 1 start date for ICD-10.

Kristi Matus, chief financial and administrative officer for Athenahealth, testified to the general readiness of the health IT community to make the switch to ICD-10. The government should either “maintain the current date for ICD-10 implementation or cancel it once and for all. Pull the trigger or pull the plug,” Ms. Matus said.

Dr. William J. Terry Sr., a urologist from Mobile, Ala., testified on behalf of the American Urological Association and expressed concern that not all physicians are ready. He suggested that a transition period might allow physicians and other providers to run ICD-9 and ICD-10 simultaneously to ensure that physicians do not inadvertently lose any payments because of coding errors that might occur as they learn the new system.

[email protected]

A validated genomic classifier score based on 22 prespecified biomarkers is prognostic for the development of clinical metastasis after radical prostatectomy, and could help inform decision making about the timing of subsequent radiotherapy, according to a review of 188 patients who were treated with post–radical prostatectomy radiotherapy.

The findings suggest that patients with a low genomic classifier (GC) score are best treated with salvage radiotherapy (SRT), and those with a high score are best treated with adjuvant radiotherapy (ART), reported Dr. Robert B. Den of Thomas Jefferson University, Philadelphia, and his colleagues. The study was published online Feb. 9 in the Journal of Clinical Oncology.

The 5-year cumulative incidence of metastasis in the study subjects, who were identified from the GenomeDx prostate cancer genomic database, was 0%, 9%, and 29% in those with low (less than 0.4), average (0.4-0.6), and high (greater than 0.6) GC scores, respectively. On multivariable analysis, pre–radical prostatectomy prostate-specific antigen levels and GC were independent predictors of metastasis (hazard ratio, 2.12; hazard ratio, 1.90 for every 10% increase in GC score, respectively). No differences were seen in the cumulative incidence of metastasis when patients with GC scores less than 0.4 were compared based on whether they received ART or SRT, but among those with GC scores of 0.4 or higher, the cumulative incidence of metastasis at 5 years was 6% in those who received ART, and 23% in those who received SRT (J. Clin. Oncol. 2015 Feb. 9 [doi:10.1200/JCO.2014.59.0026]).

Use of the GC scoring model either alone or in combination with the Cancer of the Prostate Risk Assessment Postsurgical (CAPRA-S) scoring model was superior to other clinicopathological models for predicting metastasis, and had “a higher net benefit than clinical models across a wide range of decision threshold probabilities,” they noted.

The patients were men with pT3 or margin-positive prostate cancer who received radiotherapy after radical prostatectomy (post-RP RT) at either Thomas Jefferson University, Philadelphia, or the Mayo Clinic, Rochester, Minn., between 1990 and 2009. They were treated at a median dose of 66.6 Gy with conventional fractionation by either three-dimensional conformal RT or by intensity-modulated RT techniques, and followed for a median of 10 years after radical prostatectomy and 8 years after radiotherapy.

The findings have important implications for the treatment of contemporary prostate cancer patients who harbor adverse pathologic characteristics at the time of radical prostatectomy; these patients are often treated with postoperative radiotherapy alone or with hormonal therapy, but the optimal timing of post-RP RT has been unclear, the investigators explained.

“Advocates for adjuvant RT argue that this treatment modality might maximize cancer control outcomes. However, salvage RT can minimize overtreatment while offering acceptable oncologic outcomes,” they wrote, adding that trials comparing the two are underway, but because of the rarity of data in the field and the unresolved controversy about the best approach to treatment, they “sought to integrate a novel biomarker test to improve clinical decision making regarding post-RP RT.

“We demonstrate that the GC is highly prognostic in the setting of postprostatectomy RT and that the GC may be a predictive marker that can help determine which patient will benefit from ART as opposed to SRT. This supports the importance of local therapy in the setting of presumed occult metastatic disease,” they said, noting that the findings are “particularly intriguing and provide a unique, more individualized approach in the management of postprostatectomy patients with adverse pathologic findings.”

While a biomarker shouldn’t replace shared patient-physician decision making, the use of the GC could provide insight into the aggressiveness of disease and aid in decision making regarding postprostatectomy therapy, they said.

Intensification of therapy in men with a high GC score who are receiving salvage radiotherapy is currently being examined in the Radiation Therapy Oncology Group 9601 randomized, phase III trial comparing SRT with SRT plus high-dose bicalutamide, the noted.

“Given that this cohort consists of high-risk patients by clinicopathologic nomograms and the utilization of a GC allowed for significant downstaging, this study has major ramifications in terms of both potential for overtreatment and substantial cost savings to the U.S. health care system. Thus, the GC is a valuable tool to aid in management of men with prostate cancer undergoing prostatectomy,” they concluded.

Dr. Den and several coauthors disclosed ties with GenomeDx Biosciences, Janssen, Medivation, CE Outcomes, Photocure, Dendreon, Astellas, Celgene, Varian, Merck KGaA, Vertex, Glenview Consulting, Bayer, NRG Oncology, and Myriad Genetics.

A validated genomic classifier score based on 22 prespecified biomarkers is prognostic for the development of clinical metastasis after radical prostatectomy, and could help inform decision making about the timing of subsequent radiotherapy, according to a review of 188 patients who were treated with post–radical prostatectomy radiotherapy.

The findings suggest that patients with a low genomic classifier (GC) score are best treated with salvage radiotherapy (SRT), and those with a high score are best treated with adjuvant radiotherapy (ART), reported Dr. Robert B. Den of Thomas Jefferson University, Philadelphia, and his colleagues. The study was published online Feb. 9 in the Journal of Clinical Oncology.

The 5-year cumulative incidence of metastasis in the study subjects, who were identified from the GenomeDx prostate cancer genomic database, was 0%, 9%, and 29% in those with low (less than 0.4), average (0.4-0.6), and high (greater than 0.6) GC scores, respectively. On multivariable analysis, pre–radical prostatectomy prostate-specific antigen levels and GC were independent predictors of metastasis (hazard ratio, 2.12; hazard ratio, 1.90 for every 10% increase in GC score, respectively). No differences were seen in the cumulative incidence of metastasis when patients with GC scores less than 0.4 were compared based on whether they received ART or SRT, but among those with GC scores of 0.4 or higher, the cumulative incidence of metastasis at 5 years was 6% in those who received ART, and 23% in those who received SRT (J. Clin. Oncol. 2015 Feb. 9 [doi:10.1200/JCO.2014.59.0026]).

Use of the GC scoring model either alone or in combination with the Cancer of the Prostate Risk Assessment Postsurgical (CAPRA-S) scoring model was superior to other clinicopathological models for predicting metastasis, and had “a higher net benefit than clinical models across a wide range of decision threshold probabilities,” they noted.

The patients were men with pT3 or margin-positive prostate cancer who received radiotherapy after radical prostatectomy (post-RP RT) at either Thomas Jefferson University, Philadelphia, or the Mayo Clinic, Rochester, Minn., between 1990 and 2009. They were treated at a median dose of 66.6 Gy with conventional fractionation by either three-dimensional conformal RT or by intensity-modulated RT techniques, and followed for a median of 10 years after radical prostatectomy and 8 years after radiotherapy.

The findings have important implications for the treatment of contemporary prostate cancer patients who harbor adverse pathologic characteristics at the time of radical prostatectomy; these patients are often treated with postoperative radiotherapy alone or with hormonal therapy, but the optimal timing of post-RP RT has been unclear, the investigators explained.

“Advocates for adjuvant RT argue that this treatment modality might maximize cancer control outcomes. However, salvage RT can minimize overtreatment while offering acceptable oncologic outcomes,” they wrote, adding that trials comparing the two are underway, but because of the rarity of data in the field and the unresolved controversy about the best approach to treatment, they “sought to integrate a novel biomarker test to improve clinical decision making regarding post-RP RT.

“We demonstrate that the GC is highly prognostic in the setting of postprostatectomy RT and that the GC may be a predictive marker that can help determine which patient will benefit from ART as opposed to SRT. This supports the importance of local therapy in the setting of presumed occult metastatic disease,” they said, noting that the findings are “particularly intriguing and provide a unique, more individualized approach in the management of postprostatectomy patients with adverse pathologic findings.”

While a biomarker shouldn’t replace shared patient-physician decision making, the use of the GC could provide insight into the aggressiveness of disease and aid in decision making regarding postprostatectomy therapy, they said.

Intensification of therapy in men with a high GC score who are receiving salvage radiotherapy is currently being examined in the Radiation Therapy Oncology Group 9601 randomized, phase III trial comparing SRT with SRT plus high-dose bicalutamide, the noted.

“Given that this cohort consists of high-risk patients by clinicopathologic nomograms and the utilization of a GC allowed for significant downstaging, this study has major ramifications in terms of both potential for overtreatment and substantial cost savings to the U.S. health care system. Thus, the GC is a valuable tool to aid in management of men with prostate cancer undergoing prostatectomy,” they concluded.

Dr. Den and several coauthors disclosed ties with GenomeDx Biosciences, Janssen, Medivation, CE Outcomes, Photocure, Dendreon, Astellas, Celgene, Varian, Merck KGaA, Vertex, Glenview Consulting, Bayer, NRG Oncology, and Myriad Genetics.

A validated genomic classifier score based on 22 prespecified biomarkers is prognostic for the development of clinical metastasis after radical prostatectomy, and could help inform decision making about the timing of subsequent radiotherapy, according to a review of 188 patients who were treated with post–radical prostatectomy radiotherapy.

The findings suggest that patients with a low genomic classifier (GC) score are best treated with salvage radiotherapy (SRT), and those with a high score are best treated with adjuvant radiotherapy (ART), reported Dr. Robert B. Den of Thomas Jefferson University, Philadelphia, and his colleagues. The study was published online Feb. 9 in the Journal of Clinical Oncology.

The 5-year cumulative incidence of metastasis in the study subjects, who were identified from the GenomeDx prostate cancer genomic database, was 0%, 9%, and 29% in those with low (less than 0.4), average (0.4-0.6), and high (greater than 0.6) GC scores, respectively. On multivariable analysis, pre–radical prostatectomy prostate-specific antigen levels and GC were independent predictors of metastasis (hazard ratio, 2.12; hazard ratio, 1.90 for every 10% increase in GC score, respectively). No differences were seen in the cumulative incidence of metastasis when patients with GC scores less than 0.4 were compared based on whether they received ART or SRT, but among those with GC scores of 0.4 or higher, the cumulative incidence of metastasis at 5 years was 6% in those who received ART, and 23% in those who received SRT (J. Clin. Oncol. 2015 Feb. 9 [doi:10.1200/JCO.2014.59.0026]).

Use of the GC scoring model either alone or in combination with the Cancer of the Prostate Risk Assessment Postsurgical (CAPRA-S) scoring model was superior to other clinicopathological models for predicting metastasis, and had “a higher net benefit than clinical models across a wide range of decision threshold probabilities,” they noted.

The patients were men with pT3 or margin-positive prostate cancer who received radiotherapy after radical prostatectomy (post-RP RT) at either Thomas Jefferson University, Philadelphia, or the Mayo Clinic, Rochester, Minn., between 1990 and 2009. They were treated at a median dose of 66.6 Gy with conventional fractionation by either three-dimensional conformal RT or by intensity-modulated RT techniques, and followed for a median of 10 years after radical prostatectomy and 8 years after radiotherapy.

The findings have important implications for the treatment of contemporary prostate cancer patients who harbor adverse pathologic characteristics at the time of radical prostatectomy; these patients are often treated with postoperative radiotherapy alone or with hormonal therapy, but the optimal timing of post-RP RT has been unclear, the investigators explained.

“Advocates for adjuvant RT argue that this treatment modality might maximize cancer control outcomes. However, salvage RT can minimize overtreatment while offering acceptable oncologic outcomes,” they wrote, adding that trials comparing the two are underway, but because of the rarity of data in the field and the unresolved controversy about the best approach to treatment, they “sought to integrate a novel biomarker test to improve clinical decision making regarding post-RP RT.

“We demonstrate that the GC is highly prognostic in the setting of postprostatectomy RT and that the GC may be a predictive marker that can help determine which patient will benefit from ART as opposed to SRT. This supports the importance of local therapy in the setting of presumed occult metastatic disease,” they said, noting that the findings are “particularly intriguing and provide a unique, more individualized approach in the management of postprostatectomy patients with adverse pathologic findings.”

While a biomarker shouldn’t replace shared patient-physician decision making, the use of the GC could provide insight into the aggressiveness of disease and aid in decision making regarding postprostatectomy therapy, they said.

Intensification of therapy in men with a high GC score who are receiving salvage radiotherapy is currently being examined in the Radiation Therapy Oncology Group 9601 randomized, phase III trial comparing SRT with SRT plus high-dose bicalutamide, the noted.

“Given that this cohort consists of high-risk patients by clinicopathologic nomograms and the utilization of a GC allowed for significant downstaging, this study has major ramifications in terms of both potential for overtreatment and substantial cost savings to the U.S. health care system. Thus, the GC is a valuable tool to aid in management of men with prostate cancer undergoing prostatectomy,” they concluded.

Dr. Den and several coauthors disclosed ties with GenomeDx Biosciences, Janssen, Medivation, CE Outcomes, Photocure, Dendreon, Astellas, Celgene, Varian, Merck KGaA, Vertex, Glenview Consulting, Bayer, NRG Oncology, and Myriad Genetics.

LAKE BUENA VISTA, FLA. – Contrary to prior results, use of onabotulinumtoxinA did not improve primary fascial closure rates after damage control laparotomy in a multicenter, prospective study.

“Botox injections were safe, but they did not have any effect on our primary or secondary endpoints,” Dr. Martin D. Zielinski said at the annual scientific assembly of the Eastern Association for the Surgery of Trauma (EAST).

Patrice Wendling/Frontline Medical News

Dr. Zielinski and his colleagues at Mayo Clinic, Rochester, Minn., previously published retrospective data showing that use of Botox-induced paralysis of the abdominal wall musculature resulted in a primary fascial closure rate of 83% among 18 patients with open abdomen (OA) and 89% if injected within 24 hours of the initial OA procedure (Hernia 2013;17:101-7).

In contrast, the primary closure rate was just 66% in a prospective American Association for the Surgery of Trauma study involving 572 patients requiring OA management after damage control laparotomy (J. Trauma Acute Care Surg. 2013;74:113-20).

Though negative pressure dressings and use of patches have been shown to increase primary closure by facilitating the midline tension, up to 30% of patients will not achieve primary fascial closure. Botox injections block the release of acetylcholine, thereby preventing a rush of calcium to the abdomen and inducing flaccid paralysis of the lateral abdominal wall muscles, Dr. Zielinski explained.

To test their hypothesis that Botox would improve rates of primary fascial closure, decrease hospital stay, and enhance pain control, 46 patients who had undergone damage control laparotomy were randomly assigned to six separate injections of their external, oblique, internal oblique, and transverse abdominal muscles with 150 cc/injection of Botox A or sodium chloride 0.9%.

The two groups were well matched, with the exception of Botox patients having a significantly lower body mass index (BMI) than did controls (30 kg/m²vs. 26.3 kg/m²) and receiving more intraoperative packed red blood cells (8 units vs. 4.8 units).

Primary fascial closure rates were unexpectedly high, but did not differ between the Botox and control groups (96% vs. 93%; hazard ratio, 1.0), Dr. Zielinski said.

Secondary endpoints were also similar between the Botox and control groups including average time until closure (5 days vs. 2 days; P = .15), hospital stay (24 days vs. 19 days; P = .19), median ICU duration (8 days vs. 6 days; P = 32), and wound infection rate (8% vs. 0%; P > .99).

Given the potential pain effects of Botox, the investigators anticipated a difference in pain medication use, but morphine equivalents were actually slightly higher in the Botox group on postoperative day 1 (120 mg vs. 81.8 mg; P = .27) through day 5 (57.3 vs. 49.0 mg; P = .47), he said.

In trying to explain why the injections failed to prove beneficial, Dr. Zielinski said, “The question that crosses my mind is did we exclude the wrong patients?”

A total of 181 trauma or emergency general surgery patients, aged 18 years and older, with a damage-control laparotomy per the surgeon’s discretion were eligible for the double-blind study, but 87 were excluded because they had one or more exclusion criterion: a body mass index ≥ 50, hemodynamic instability, complicated chronic obstructive pulmonary disease, impaired neuromuscular transmission, aminoglycoside use, international normalized ratio < 1.5, trunk necrotizing fasciitis, metastatic malignancy, or were pregnant or a prisoner.

Patrice Wendling/Frontline Medical News

Discussant Michael Rotondo of the University of Rochester (New York) Medical Center, applauded the authors for presenting a negative study and called it “impeccably designed” and “a great piece of work.”

Dr. Rotondo went on to ask whether there was any relationship between degree of advancement, abdominal breach, or lateral diameter that predicts success with Botox.

Despite the use of surface wave elastography to measure abdominal tension in eight patients and use of a handheld durometer, Dr. Zielinski said they were unable to accurately measure degree of advancement. Future work may look at the relationship between these factors and will include long-term follow-up to evaluate hernia rates and quality of life. In the one patient with full elastography measurements, abdominal tension trended lower for 2 days after the Botox injection before increasing after primary closure, he said.abdominal tension trended lower for 2 days after the Botox injection before increasing after primary closure, he said.

The study was funded by the EAST Scholar program. Dr. Zielinski, his coauthors, and Dr. Rotondo reported having no financial disclosures.

[email protected]

LAKE BUENA VISTA, FLA. – Contrary to prior results, use of onabotulinumtoxinA did not improve primary fascial closure rates after damage control laparotomy in a multicenter, prospective study.

“Botox injections were safe, but they did not have any effect on our primary or secondary endpoints,” Dr. Martin D. Zielinski said at the annual scientific assembly of the Eastern Association for the Surgery of Trauma (EAST).

Patrice Wendling/Frontline Medical News

Dr. Zielinski and his colleagues at Mayo Clinic, Rochester, Minn., previously published retrospective data showing that use of Botox-induced paralysis of the abdominal wall musculature resulted in a primary fascial closure rate of 83% among 18 patients with open abdomen (OA) and 89% if injected within 24 hours of the initial OA procedure (Hernia 2013;17:101-7).

In contrast, the primary closure rate was just 66% in a prospective American Association for the Surgery of Trauma study involving 572 patients requiring OA management after damage control laparotomy (J. Trauma Acute Care Surg. 2013;74:113-20).

Though negative pressure dressings and use of patches have been shown to increase primary closure by facilitating the midline tension, up to 30% of patients will not achieve primary fascial closure. Botox injections block the release of acetylcholine, thereby preventing a rush of calcium to the abdomen and inducing flaccid paralysis of the lateral abdominal wall muscles, Dr. Zielinski explained.

To test their hypothesis that Botox would improve rates of primary fascial closure, decrease hospital stay, and enhance pain control, 46 patients who had undergone damage control laparotomy were randomly assigned to six separate injections of their external, oblique, internal oblique, and transverse abdominal muscles with 150 cc/injection of Botox A or sodium chloride 0.9%.

The two groups were well matched, with the exception of Botox patients having a significantly lower body mass index (BMI) than did controls (30 kg/m²vs. 26.3 kg/m²) and receiving more intraoperative packed red blood cells (8 units vs. 4.8 units).

Primary fascial closure rates were unexpectedly high, but did not differ between the Botox and control groups (96% vs. 93%; hazard ratio, 1.0), Dr. Zielinski said.

Secondary endpoints were also similar between the Botox and control groups including average time until closure (5 days vs. 2 days; P = .15), hospital stay (24 days vs. 19 days; P = .19), median ICU duration (8 days vs. 6 days; P = 32), and wound infection rate (8% vs. 0%; P > .99).

Given the potential pain effects of Botox, the investigators anticipated a difference in pain medication use, but morphine equivalents were actually slightly higher in the Botox group on postoperative day 1 (120 mg vs. 81.8 mg; P = .27) through day 5 (57.3 vs. 49.0 mg; P = .47), he said.

In trying to explain why the injections failed to prove beneficial, Dr. Zielinski said, “The question that crosses my mind is did we exclude the wrong patients?”

A total of 181 trauma or emergency general surgery patients, aged 18 years and older, with a damage-control laparotomy per the surgeon’s discretion were eligible for the double-blind study, but 87 were excluded because they had one or more exclusion criterion: a body mass index ≥ 50, hemodynamic instability, complicated chronic obstructive pulmonary disease, impaired neuromuscular transmission, aminoglycoside use, international normalized ratio < 1.5, trunk necrotizing fasciitis, metastatic malignancy, or were pregnant or a prisoner.

Patrice Wendling/Frontline Medical News

Discussant Michael Rotondo of the University of Rochester (New York) Medical Center, applauded the authors for presenting a negative study and called it “impeccably designed” and “a great piece of work.”

Dr. Rotondo went on to ask whether there was any relationship between degree of advancement, abdominal breach, or lateral diameter that predicts success with Botox.

Despite the use of surface wave elastography to measure abdominal tension in eight patients and use of a handheld durometer, Dr. Zielinski said they were unable to accurately measure degree of advancement. Future work may look at the relationship between these factors and will include long-term follow-up to evaluate hernia rates and quality of life. In the one patient with full elastography measurements, abdominal tension trended lower for 2 days after the Botox injection before increasing after primary closure, he said.abdominal tension trended lower for 2 days after the Botox injection before increasing after primary closure, he said.

The study was funded by the EAST Scholar program. Dr. Zielinski, his coauthors, and Dr. Rotondo reported having no financial disclosures.

[email protected]

LAKE BUENA VISTA, FLA. – Contrary to prior results, use of onabotulinumtoxinA did not improve primary fascial closure rates after damage control laparotomy in a multicenter, prospective study.

“Botox injections were safe, but they did not have any effect on our primary or secondary endpoints,” Dr. Martin D. Zielinski said at the annual scientific assembly of the Eastern Association for the Surgery of Trauma (EAST).

Patrice Wendling/Frontline Medical News

Dr. Zielinski and his colleagues at Mayo Clinic, Rochester, Minn., previously published retrospective data showing that use of Botox-induced paralysis of the abdominal wall musculature resulted in a primary fascial closure rate of 83% among 18 patients with open abdomen (OA) and 89% if injected within 24 hours of the initial OA procedure (Hernia 2013;17:101-7).

In contrast, the primary closure rate was just 66% in a prospective American Association for the Surgery of Trauma study involving 572 patients requiring OA management after damage control laparotomy (J. Trauma Acute Care Surg. 2013;74:113-20).

Though negative pressure dressings and use of patches have been shown to increase primary closure by facilitating the midline tension, up to 30% of patients will not achieve primary fascial closure. Botox injections block the release of acetylcholine, thereby preventing a rush of calcium to the abdomen and inducing flaccid paralysis of the lateral abdominal wall muscles, Dr. Zielinski explained.

To test their hypothesis that Botox would improve rates of primary fascial closure, decrease hospital stay, and enhance pain control, 46 patients who had undergone damage control laparotomy were randomly assigned to six separate injections of their external, oblique, internal oblique, and transverse abdominal muscles with 150 cc/injection of Botox A or sodium chloride 0.9%.

The two groups were well matched, with the exception of Botox patients having a significantly lower body mass index (BMI) than did controls (30 kg/m²vs. 26.3 kg/m²) and receiving more intraoperative packed red blood cells (8 units vs. 4.8 units).

Primary fascial closure rates were unexpectedly high, but did not differ between the Botox and control groups (96% vs. 93%; hazard ratio, 1.0), Dr. Zielinski said.

Secondary endpoints were also similar between the Botox and control groups including average time until closure (5 days vs. 2 days; P = .15), hospital stay (24 days vs. 19 days; P = .19), median ICU duration (8 days vs. 6 days; P = 32), and wound infection rate (8% vs. 0%; P > .99).

Given the potential pain effects of Botox, the investigators anticipated a difference in pain medication use, but morphine equivalents were actually slightly higher in the Botox group on postoperative day 1 (120 mg vs. 81.8 mg; P = .27) through day 5 (57.3 vs. 49.0 mg; P = .47), he said.

In trying to explain why the injections failed to prove beneficial, Dr. Zielinski said, “The question that crosses my mind is did we exclude the wrong patients?”

A total of 181 trauma or emergency general surgery patients, aged 18 years and older, with a damage-control laparotomy per the surgeon’s discretion were eligible for the double-blind study, but 87 were excluded because they had one or more exclusion criterion: a body mass index ≥ 50, hemodynamic instability, complicated chronic obstructive pulmonary disease, impaired neuromuscular transmission, aminoglycoside use, international normalized ratio < 1.5, trunk necrotizing fasciitis, metastatic malignancy, or were pregnant or a prisoner.

Patrice Wendling/Frontline Medical News

Discussant Michael Rotondo of the University of Rochester (New York) Medical Center, applauded the authors for presenting a negative study and called it “impeccably designed” and “a great piece of work.”

Dr. Rotondo went on to ask whether there was any relationship between degree of advancement, abdominal breach, or lateral diameter that predicts success with Botox.

Despite the use of surface wave elastography to measure abdominal tension in eight patients and use of a handheld durometer, Dr. Zielinski said they were unable to accurately measure degree of advancement. Future work may look at the relationship between these factors and will include long-term follow-up to evaluate hernia rates and quality of life. In the one patient with full elastography measurements, abdominal tension trended lower for 2 days after the Botox injection before increasing after primary closure, he said.abdominal tension trended lower for 2 days after the Botox injection before increasing after primary closure, he said.

The study was funded by the EAST Scholar program. Dr. Zielinski, his coauthors, and Dr. Rotondo reported having no financial disclosures.

[email protected]

The majority of patients undergoing pancreaticoduodenectomy will not develop pancreatic fistula and may safely have drains removed on the first postoperative day, a prospective cohort study has found.

Less than 1% of patients with drain amylase levels below 600 U/L on postoperative day 1 will develop pancreatic fistula (PF). This means that in this group – which represents about 60% of PD patients – early drain removal may be a safe management option.

For their research, published online in Annals of Surgery (2015 Jan. 12 [doi:10.1097/SLA.0000000000001038), Dr. Zhi Ven Fong and colleagues at Massachusetts General Hospital and Harvard Medical School, Boston, sought to find the threshold value for drain amylase that predicts fistula, with the goal of helping guide surgeons’ decisions on drain management.

Most surgeons place intraperitoneal drains during PD to control leakage in the event that anastomoses fail. However, some surgeons have abandoned drain placement after PD out of concerns that drains can introduce infection and cause other complications, with risks increasing the longer drains are in place. Drain placement followed by amylase measurement and early removal in low-risk patients “represents a middle ground between the two practices,” Dr. Fong and colleagues wrote.

The investigators evaluated results from two cohorts of consecutive patients undergoing pancreaticoduodenectomy at their surgical center, an initial training cohort (n = 126) and a validation cohort (n = 369). Closed-suction drains were used in all patients, and drain output and amylase levels were prospectively measured daily until drain removal or patient discharge.

Results from the first cohort showed that a drain amylase level of 612 U/L or higher showed the best accuracy (86%), sensitivity (93%), and specificity (79%) in predicting fistula, compared with other established variables.

In the larger validation cohort, the 140 patients with drain amylase values of 600 or higher on postoperative day 1 saw a PF rate of 31.4% (odds ratio = 52, P < .0001). Of the 229 patients with values lower than 600, a group comprising 62.1% of the cohort, fistula developed in only two cases (0.9%). An amylase value below 600 proved a stronger predictor of the absence of PF (OR = 0.0192, P < .0001) than pancreatic gland texture (OR = 0.193, P = .002) and duct diameter (OR = 0.861, P = .835).

“We believe that the debate [over] current intraperitoneal drain management after PD should not be ‘to drain or not to drain’ but rather ‘who and when can we stop draining,’ ” Dr. Fong and colleagues wrote.

“Risk of PF is less than 1% if POD [postoperative day] 1 drain amylase level is lower than 600 U/L. We propose that in this group, which comprises more than 60% of patients, intraperitoneal drains should be removed on PODs 1 and 2, and are currently validating this strategy in our practice,” they wrote.

The investigators cautioned, however, that theirs was a one-site study at an institution whose fistula rates after PD are low, compared with historic rates. “Utilizing POD 1 drain amylase of less than 600 U/L as an early stratification of patients to guide drain removal should not be assumed to be a universally safe practice,” they wrote, until data from larger multisite studies become available.

Dr. Fong and colleagues disclosed no external funding or conflicts of interest.

The majority of patients undergoing pancreaticoduodenectomy will not develop pancreatic fistula and may safely have drains removed on the first postoperative day, a prospective cohort study has found.

Less than 1% of patients with drain amylase levels below 600 U/L on postoperative day 1 will develop pancreatic fistula (PF). This means that in this group – which represents about 60% of PD patients – early drain removal may be a safe management option.

For their research, published online in Annals of Surgery (2015 Jan. 12 [doi:10.1097/SLA.0000000000001038), Dr. Zhi Ven Fong and colleagues at Massachusetts General Hospital and Harvard Medical School, Boston, sought to find the threshold value for drain amylase that predicts fistula, with the goal of helping guide surgeons’ decisions on drain management.

Most surgeons place intraperitoneal drains during PD to control leakage in the event that anastomoses fail. However, some surgeons have abandoned drain placement after PD out of concerns that drains can introduce infection and cause other complications, with risks increasing the longer drains are in place. Drain placement followed by amylase measurement and early removal in low-risk patients “represents a middle ground between the two practices,” Dr. Fong and colleagues wrote.

The investigators evaluated results from two cohorts of consecutive patients undergoing pancreaticoduodenectomy at their surgical center, an initial training cohort (n = 126) and a validation cohort (n = 369). Closed-suction drains were used in all patients, and drain output and amylase levels were prospectively measured daily until drain removal or patient discharge.

Results from the first cohort showed that a drain amylase level of 612 U/L or higher showed the best accuracy (86%), sensitivity (93%), and specificity (79%) in predicting fistula, compared with other established variables.

In the larger validation cohort, the 140 patients with drain amylase values of 600 or higher on postoperative day 1 saw a PF rate of 31.4% (odds ratio = 52, P < .0001). Of the 229 patients with values lower than 600, a group comprising 62.1% of the cohort, fistula developed in only two cases (0.9%). An amylase value below 600 proved a stronger predictor of the absence of PF (OR = 0.0192, P < .0001) than pancreatic gland texture (OR = 0.193, P = .002) and duct diameter (OR = 0.861, P = .835).

“We believe that the debate [over] current intraperitoneal drain management after PD should not be ‘to drain or not to drain’ but rather ‘who and when can we stop draining,’ ” Dr. Fong and colleagues wrote.

“Risk of PF is less than 1% if POD [postoperative day] 1 drain amylase level is lower than 600 U/L. We propose that in this group, which comprises more than 60% of patients, intraperitoneal drains should be removed on PODs 1 and 2, and are currently validating this strategy in our practice,” they wrote.

The investigators cautioned, however, that theirs was a one-site study at an institution whose fistula rates after PD are low, compared with historic rates. “Utilizing POD 1 drain amylase of less than 600 U/L as an early stratification of patients to guide drain removal should not be assumed to be a universally safe practice,” they wrote, until data from larger multisite studies become available.

Dr. Fong and colleagues disclosed no external funding or conflicts of interest.

The majority of patients undergoing pancreaticoduodenectomy will not develop pancreatic fistula and may safely have drains removed on the first postoperative day, a prospective cohort study has found.

Less than 1% of patients with drain amylase levels below 600 U/L on postoperative day 1 will develop pancreatic fistula (PF). This means that in this group – which represents about 60% of PD patients – early drain removal may be a safe management option.

For their research, published online in Annals of Surgery (2015 Jan. 12 [doi:10.1097/SLA.0000000000001038), Dr. Zhi Ven Fong and colleagues at Massachusetts General Hospital and Harvard Medical School, Boston, sought to find the threshold value for drain amylase that predicts fistula, with the goal of helping guide surgeons’ decisions on drain management.

Most surgeons place intraperitoneal drains during PD to control leakage in the event that anastomoses fail. However, some surgeons have abandoned drain placement after PD out of concerns that drains can introduce infection and cause other complications, with risks increasing the longer drains are in place. Drain placement followed by amylase measurement and early removal in low-risk patients “represents a middle ground between the two practices,” Dr. Fong and colleagues wrote.

The investigators evaluated results from two cohorts of consecutive patients undergoing pancreaticoduodenectomy at their surgical center, an initial training cohort (n = 126) and a validation cohort (n = 369). Closed-suction drains were used in all patients, and drain output and amylase levels were prospectively measured daily until drain removal or patient discharge.

Results from the first cohort showed that a drain amylase level of 612 U/L or higher showed the best accuracy (86%), sensitivity (93%), and specificity (79%) in predicting fistula, compared with other established variables.

In the larger validation cohort, the 140 patients with drain amylase values of 600 or higher on postoperative day 1 saw a PF rate of 31.4% (odds ratio = 52, P < .0001). Of the 229 patients with values lower than 600, a group comprising 62.1% of the cohort, fistula developed in only two cases (0.9%). An amylase value below 600 proved a stronger predictor of the absence of PF (OR = 0.0192, P < .0001) than pancreatic gland texture (OR = 0.193, P = .002) and duct diameter (OR = 0.861, P = .835).

“We believe that the debate [over] current intraperitoneal drain management after PD should not be ‘to drain or not to drain’ but rather ‘who and when can we stop draining,’ ” Dr. Fong and colleagues wrote.

“Risk of PF is less than 1% if POD [postoperative day] 1 drain amylase level is lower than 600 U/L. We propose that in this group, which comprises more than 60% of patients, intraperitoneal drains should be removed on PODs 1 and 2, and are currently validating this strategy in our practice,” they wrote.

The investigators cautioned, however, that theirs was a one-site study at an institution whose fistula rates after PD are low, compared with historic rates. “Utilizing POD 1 drain amylase of less than 600 U/L as an early stratification of patients to guide drain removal should not be assumed to be a universally safe practice,” they wrote, until data from larger multisite studies become available.

Dr. Fong and colleagues disclosed no external funding or conflicts of interest.

No more extensions are expected on the ICD-10 implementation deadline, according to leadership of the Senate Finance Committee.

Based on information released in a Feb. 6 Government Accountability Office report, there is no reason to delay implementation any further, Sen. Orrin Hatch (R-Utah), Finance Committee chairman, and Sen. Ron Wyden (D-Ore.), the committee’s ranking member, said in a joint statement.

The GAO report examines efforts by the Centers for Medicare & Medicaid Services to prepare for the transition to ICD-10 and to address physician concerns about the transition. The GAO found that CMS has completed all ICD-10–related changes to its Medicare payment system, though work still needs to be done to prepare for the transition on the state level for the Medicaid program.

“As demonstrated by this report, the provider outreach and responsiveness to stakeholder concerns from CMS have kept the agency on track to upgrade to the next level of health care coding,” Sen. Hatch said.

“CMS has taken unprecedented actions to help providers prepare for this change,” Sen. Wyden added. “We will continue to monitor the testing CMS is conducting as we near the Oct. 1 implementation date.”

The House Energy & Commerce Committee’s Subcommittee on Health will hold a hearing Feb. 11 to review the ICD-10 transition readiness.

[email protected]

No more extensions are expected on the ICD-10 implementation deadline, according to leadership of the Senate Finance Committee.

Based on information released in a Feb. 6 Government Accountability Office report, there is no reason to delay implementation any further, Sen. Orrin Hatch (R-Utah), Finance Committee chairman, and Sen. Ron Wyden (D-Ore.), the committee’s ranking member, said in a joint statement.

The GAO report examines efforts by the Centers for Medicare & Medicaid Services to prepare for the transition to ICD-10 and to address physician concerns about the transition. The GAO found that CMS has completed all ICD-10–related changes to its Medicare payment system, though work still needs to be done to prepare for the transition on the state level for the Medicaid program.

“As demonstrated by this report, the provider outreach and responsiveness to stakeholder concerns from CMS have kept the agency on track to upgrade to the next level of health care coding,” Sen. Hatch said.

“CMS has taken unprecedented actions to help providers prepare for this change,” Sen. Wyden added. “We will continue to monitor the testing CMS is conducting as we near the Oct. 1 implementation date.”

The House Energy & Commerce Committee’s Subcommittee on Health will hold a hearing Feb. 11 to review the ICD-10 transition readiness.

[email protected]

No more extensions are expected on the ICD-10 implementation deadline, according to leadership of the Senate Finance Committee.

Based on information released in a Feb. 6 Government Accountability Office report, there is no reason to delay implementation any further, Sen. Orrin Hatch (R-Utah), Finance Committee chairman, and Sen. Ron Wyden (D-Ore.), the committee’s ranking member, said in a joint statement.

The GAO report examines efforts by the Centers for Medicare & Medicaid Services to prepare for the transition to ICD-10 and to address physician concerns about the transition. The GAO found that CMS has completed all ICD-10–related changes to its Medicare payment system, though work still needs to be done to prepare for the transition on the state level for the Medicaid program.

“As demonstrated by this report, the provider outreach and responsiveness to stakeholder concerns from CMS have kept the agency on track to upgrade to the next level of health care coding,” Sen. Hatch said.

“CMS has taken unprecedented actions to help providers prepare for this change,” Sen. Wyden added. “We will continue to monitor the testing CMS is conducting as we near the Oct. 1 implementation date.”

The House Energy & Commerce Committee’s Subcommittee on Health will hold a hearing Feb. 11 to review the ICD-10 transition readiness.

[email protected]

Minimally invasive esophagectomy can be performed with low perioperative morbidity and mortality in patients with esophageal cancer, according to results from a study conducted at 17 surgical centers.

Single-site studies have shown mortality and morbidity associated with MIE to be low, compared with historic rates for open procedures; the new study, led Dr. James D. Luketich of the University of Pittsburgh, and published in advance of print in Annals of Surgery (2015 Jan. 8 [doi:10.1097/SLA.0000000000000993]), was the first to look at morbidity and mortality from minimally invasive esophagectomy (MIE) performed prospectively at multiple study sites.

Dr. Luketich and his colleagues recruited 104 patients with esophageal cancers or high-grade dysplasia and assigned them to MIE using video-assisted thorascopy and laparoscopy. Of the 95 patients who underwent the completely minimally invasive procedure as planned, 30-day mortality was 2.1%. For the broader study group, which included nine patients who received operations that differed from the study protocol, mortality was 2.9%.

Though single-site studies of MIE have seen mortality at below 2%, historic rates for open procedures have ranged from 8% to 23% in the United States, though mortality rates appear to be dropping. MIE has been shown in one randomized trial to be associated with significantly fewer pulmonary infections, compared with open procedures, and shorter hospital stays (Dig. Dis. Sci.2010;55:3031-40).

Patients in Dr. Luketich and colleagues’ study stayed a median of 2 days in intensive care and 9 days in the hospital. Serious adverse events included anastomotic leak (8.6%), acute respiratory distress syndrome (5.7%), pneumonitis (3.8%), and atrial fibrillation (2.9%).

Dr. Luketich and colleagues described the oncologic outcomes of their study as acceptable, compared with published results from open procedures. With a median follow-up of 35.8 months, estimated 3-year overall survival was 58.4% (95% confidence interval, 47.7%–67.6%), with locoregional recurrence seen in only seven patients (6.9%). This, the investigators reported, is comparable with survival results from open procedures.

“This study demonstrates the feasibility of this approach in a multicenter setting,” the investigators wrote in their analysis. “However, it should also be emphasized that the procedures were performed by credentialed surgeons with demonstrated experience in esophageal surgery and minimally invasive techniques.”

The minimally invasive approach can be adopted by other centers, Dr. Luketich and colleagues wrote, “provided that appropriate expertise with both open esophagectomy and minimally invasive techniques is available.”

The study was coordinated by the Eastern Cooperative Oncology Group and funded by grants from the National Cancer Institute, the National Institutes of Health, and the U.S. Department of Health & Human Services. Dr. Luketich and colleagues disclosed no conflicts of interest related to their research.

Minimally invasive esophagectomy can be performed with low perioperative morbidity and mortality in patients with esophageal cancer, according to results from a study conducted at 17 surgical centers.

Single-site studies have shown mortality and morbidity associated with MIE to be low, compared with historic rates for open procedures; the new study, led Dr. James D. Luketich of the University of Pittsburgh, and published in advance of print in Annals of Surgery (2015 Jan. 8 [doi:10.1097/SLA.0000000000000993]), was the first to look at morbidity and mortality from minimally invasive esophagectomy (MIE) performed prospectively at multiple study sites.

Dr. Luketich and his colleagues recruited 104 patients with esophageal cancers or high-grade dysplasia and assigned them to MIE using video-assisted thorascopy and laparoscopy. Of the 95 patients who underwent the completely minimally invasive procedure as planned, 30-day mortality was 2.1%. For the broader study group, which included nine patients who received operations that differed from the study protocol, mortality was 2.9%.

Though single-site studies of MIE have seen mortality at below 2%, historic rates for open procedures have ranged from 8% to 23% in the United States, though mortality rates appear to be dropping. MIE has been shown in one randomized trial to be associated with significantly fewer pulmonary infections, compared with open procedures, and shorter hospital stays (Dig. Dis. Sci.2010;55:3031-40).

Patients in Dr. Luketich and colleagues’ study stayed a median of 2 days in intensive care and 9 days in the hospital. Serious adverse events included anastomotic leak (8.6%), acute respiratory distress syndrome (5.7%), pneumonitis (3.8%), and atrial fibrillation (2.9%).

Dr. Luketich and colleagues described the oncologic outcomes of their study as acceptable, compared with published results from open procedures. With a median follow-up of 35.8 months, estimated 3-year overall survival was 58.4% (95% confidence interval, 47.7%–67.6%), with locoregional recurrence seen in only seven patients (6.9%). This, the investigators reported, is comparable with survival results from open procedures.

“This study demonstrates the feasibility of this approach in a multicenter setting,” the investigators wrote in their analysis. “However, it should also be emphasized that the procedures were performed by credentialed surgeons with demonstrated experience in esophageal surgery and minimally invasive techniques.”

The minimally invasive approach can be adopted by other centers, Dr. Luketich and colleagues wrote, “provided that appropriate expertise with both open esophagectomy and minimally invasive techniques is available.”

The study was coordinated by the Eastern Cooperative Oncology Group and funded by grants from the National Cancer Institute, the National Institutes of Health, and the U.S. Department of Health & Human Services. Dr. Luketich and colleagues disclosed no conflicts of interest related to their research.

Minimally invasive esophagectomy can be performed with low perioperative morbidity and mortality in patients with esophageal cancer, according to results from a study conducted at 17 surgical centers.

Single-site studies have shown mortality and morbidity associated with MIE to be low, compared with historic rates for open procedures; the new study, led Dr. James D. Luketich of the University of Pittsburgh, and published in advance of print in Annals of Surgery (2015 Jan. 8 [doi:10.1097/SLA.0000000000000993]), was the first to look at morbidity and mortality from minimally invasive esophagectomy (MIE) performed prospectively at multiple study sites.

Dr. Luketich and his colleagues recruited 104 patients with esophageal cancers or high-grade dysplasia and assigned them to MIE using video-assisted thorascopy and laparoscopy. Of the 95 patients who underwent the completely minimally invasive procedure as planned, 30-day mortality was 2.1%. For the broader study group, which included nine patients who received operations that differed from the study protocol, mortality was 2.9%.

Though single-site studies of MIE have seen mortality at below 2%, historic rates for open procedures have ranged from 8% to 23% in the United States, though mortality rates appear to be dropping. MIE has been shown in one randomized trial to be associated with significantly fewer pulmonary infections, compared with open procedures, and shorter hospital stays (Dig. Dis. Sci.2010;55:3031-40).

Patients in Dr. Luketich and colleagues’ study stayed a median of 2 days in intensive care and 9 days in the hospital. Serious adverse events included anastomotic leak (8.6%), acute respiratory distress syndrome (5.7%), pneumonitis (3.8%), and atrial fibrillation (2.9%).

Dr. Luketich and colleagues described the oncologic outcomes of their study as acceptable, compared with published results from open procedures. With a median follow-up of 35.8 months, estimated 3-year overall survival was 58.4% (95% confidence interval, 47.7%–67.6%), with locoregional recurrence seen in only seven patients (6.9%). This, the investigators reported, is comparable with survival results from open procedures.

“This study demonstrates the feasibility of this approach in a multicenter setting,” the investigators wrote in their analysis. “However, it should also be emphasized that the procedures were performed by credentialed surgeons with demonstrated experience in esophageal surgery and minimally invasive techniques.”

The minimally invasive approach can be adopted by other centers, Dr. Luketich and colleagues wrote, “provided that appropriate expertise with both open esophagectomy and minimally invasive techniques is available.”

The study was coordinated by the Eastern Cooperative Oncology Group and funded by grants from the National Cancer Institute, the National Institutes of Health, and the U.S. Department of Health & Human Services. Dr. Luketich and colleagues disclosed no conflicts of interest related to their research.

The use of a large-pore polypropylene mesh in colorectal surgery can reduce incidence of incisional hernias without contributing to wound complication risk, according to results from a randomized controlled trial.

While prophylactic polypropylene meshes have been used successfully in other types of surgeries to prevent hernias, they have been little studied in series of patients undergoing colorectal surgeries, a group for which incidence of IH is high, and particularly so with emergency procedures.

STEFANOLUNARDI/thinkstockphotos.com

For their research, published ahead of print in Annals of Surgery (Ann. Surg.2015 Jan 8 [doi: 10.1097/SLA.0000000000001116]), Dr. Miguel Ángel García-Ureña of Henares University Hospital in Madrid, and his colleagues, recruited 107 patients with elective or emergency colorectal surgeries using a midline laparotomy approach.

Patients were randomized to either standard care (n = 54, 20 emergency) or the addition of an overlay large-pore polypropylene mesh after the closure of the abdominal wall (n = 53, 17 emergency). All operations took place at the same hospital, with 12 surgeons participating.

At 24 months’ follow-up, the control group saw 17 incisional hernias (31.5%), compared with 6 (11.3%) in the study group (P = .011). No statistically significant differences were seen for incidence of surgical site infection, seroma, evisceration, or systemic complications, and no mesh rejection was seen.

Dr. García-Ureña and colleagues used a very low-weight, large-pore polypropylene mesh after initial studies suggested large-pore meshes were better tolerated in contaminated fields, and that these could be salvaged even in the case of site infection.

The study “confirms the safe use of large-pore polypropylene meshes even in contaminated and emergency surgical procedures,” the investigators wrote in their analysis, adding that the use of mesh overlay “was cost-effective due to the number needed to treat obtained: 1 IH was prevented for every 5 prophylactic meshes that were used.”

Dr. García-Ureña and colleagues cited as limitations of their study the fact that deaths and reoperations occurred in 28% of patients before follow-up ended, the inclusion of both elective and emergency cases, and that wound length was not recorded. Further studies will be needed, they said, to determine the ideal positioning of the mesh and the best type of mesh for these procedures.

The study authors declared no conflicts of interest.

The use of a large-pore polypropylene mesh in colorectal surgery can reduce incidence of incisional hernias without contributing to wound complication risk, according to results from a randomized controlled trial.

While prophylactic polypropylene meshes have been used successfully in other types of surgeries to prevent hernias, they have been little studied in series of patients undergoing colorectal surgeries, a group for which incidence of IH is high, and particularly so with emergency procedures.

STEFANOLUNARDI/thinkstockphotos.com

For their research, published ahead of print in Annals of Surgery (Ann. Surg.2015 Jan 8 [doi: 10.1097/SLA.0000000000001116]), Dr. Miguel Ángel García-Ureña of Henares University Hospital in Madrid, and his colleagues, recruited 107 patients with elective or emergency colorectal surgeries using a midline laparotomy approach.

Patients were randomized to either standard care (n = 54, 20 emergency) or the addition of an overlay large-pore polypropylene mesh after the closure of the abdominal wall (n = 53, 17 emergency). All operations took place at the same hospital, with 12 surgeons participating.

At 24 months’ follow-up, the control group saw 17 incisional hernias (31.5%), compared with 6 (11.3%) in the study group (P = .011). No statistically significant differences were seen for incidence of surgical site infection, seroma, evisceration, or systemic complications, and no mesh rejection was seen.

Dr. García-Ureña and colleagues used a very low-weight, large-pore polypropylene mesh after initial studies suggested large-pore meshes were better tolerated in contaminated fields, and that these could be salvaged even in the case of site infection.

The study “confirms the safe use of large-pore polypropylene meshes even in contaminated and emergency surgical procedures,” the investigators wrote in their analysis, adding that the use of mesh overlay “was cost-effective due to the number needed to treat obtained: 1 IH was prevented for every 5 prophylactic meshes that were used.”

Dr. García-Ureña and colleagues cited as limitations of their study the fact that deaths and reoperations occurred in 28% of patients before follow-up ended, the inclusion of both elective and emergency cases, and that wound length was not recorded. Further studies will be needed, they said, to determine the ideal positioning of the mesh and the best type of mesh for these procedures.

The study authors declared no conflicts of interest.

The use of a large-pore polypropylene mesh in colorectal surgery can reduce incidence of incisional hernias without contributing to wound complication risk, according to results from a randomized controlled trial.

While prophylactic polypropylene meshes have been used successfully in other types of surgeries to prevent hernias, they have been little studied in series of patients undergoing colorectal surgeries, a group for which incidence of IH is high, and particularly so with emergency procedures.

STEFANOLUNARDI/thinkstockphotos.com

For their research, published ahead of print in Annals of Surgery (Ann. Surg.2015 Jan 8 [doi: 10.1097/SLA.0000000000001116]), Dr. Miguel Ángel García-Ureña of Henares University Hospital in Madrid, and his colleagues, recruited 107 patients with elective or emergency colorectal surgeries using a midline laparotomy approach.

Patients were randomized to either standard care (n = 54, 20 emergency) or the addition of an overlay large-pore polypropylene mesh after the closure of the abdominal wall (n = 53, 17 emergency). All operations took place at the same hospital, with 12 surgeons participating.

At 24 months’ follow-up, the control group saw 17 incisional hernias (31.5%), compared with 6 (11.3%) in the study group (P = .011). No statistically significant differences were seen for incidence of surgical site infection, seroma, evisceration, or systemic complications, and no mesh rejection was seen.

Dr. García-Ureña and colleagues used a very low-weight, large-pore polypropylene mesh after initial studies suggested large-pore meshes were better tolerated in contaminated fields, and that these could be salvaged even in the case of site infection.

The study “confirms the safe use of large-pore polypropylene meshes even in contaminated and emergency surgical procedures,” the investigators wrote in their analysis, adding that the use of mesh overlay “was cost-effective due to the number needed to treat obtained: 1 IH was prevented for every 5 prophylactic meshes that were used.”

Dr. García-Ureña and colleagues cited as limitations of their study the fact that deaths and reoperations occurred in 28% of patients before follow-up ended, the inclusion of both elective and emergency cases, and that wound length was not recorded. Further studies will be needed, they said, to determine the ideal positioning of the mesh and the best type of mesh for these procedures.

The study authors declared no conflicts of interest.