Cryotherapy: Evidence-Based Interventions and Informed Consent

Cryotherapy is an effective, affordable, and safe treatment for cervical dysplasia. Despite newer technologies such as laser and loop excision, cryotherapy continues to be commonly used when the colposcopy is satisfactory, the lesions are 2 or less quadrants of the cervix, no endocervical disease is present, and there is no suspicion of invasive cancer.

In this issue of the Journal, Harper and colleagues^1,2 have presented 2 studies of the natural history of side effects of cervical cryosurgery. They have documented several important points concerning the period immediately post-treatment that have clinical implications.Hydrorrhea is an expected finding after cryotherapy. These 2 papers document the long duration of hydrorrhea (mean=11.4 days, range=1 to 57 days) and its significant discomfort to patients. More than half of the women felt this side effect was bothersome, and 25% of the group characterized it as very or extremely so. Two thirds of the patients required medication in the postoperative period. The authors have also identified subgroups (obese, multiparous, and older patients) that are more likely to suffer from these complications.

These findings have clear-cut implications concerning informed consent before cryotherapy. Patients should be informed of the expected duration of the hydrorrhea and the postoperative analgesia that may be required. Obese, multiparous, and older women should be told that on average their postoperative course tends to be more severe. Some patients may request other treatment options. Those who choose cryotherapy as a treatment option may be reassured that their healing in the postoperative period is normal.

Future Research

The work by Harper and coworkers shows that quality of life is affected by cryosurgery treatment. Future research should be done to determine how diminished the quality-of-life utilities are. The decision to use cryosurgery versus an excisional method, such as the loop electrosurgical excision procedure, most likely hinges on the experience of the treatment procedure rather than the effectiveness of the procedure. Before any cost-effectiveness analysis of cervical dysplasia treatments can be completed, the quality-of-life measures for all treatment procedures must be delineated. Only then can the quality-adjusted effectiveness of the treatment procedures be compared. Implicit in the comparison of cryosurgery to loop excision is the assumption that both treatments are equally effective for the particular cervical lesion.

Cryosurgery is often used for treatment of cervical intraepithelial neoplasia grade 1 (CIN 1) lesions. We recognize that CIN 1 lesions are a manifestation of human papillomavirus infection and will regress to normal cervical tissue without intervention approximately 60% to 80% of the time. Using a destructive method for CIN 1 lesions that has significant sequelae should be studied in a cost-effective manner, taking into account the expressed quality of life. The cost-effectiveness analysis may show us that it is rational to conservatively manage women with CIN 1 for a year then treat with cryosurgery if the lesion is still present, or it may show that immediate treatment is most cost-effective. This important work is yet to be done.

In addition, it is anticipated that the compliance rate with future routine screening practices could be affected by the cervical treatment procedure chosen. If women do not return in a timely manner for rescreening after treatment because of the bad healing experience, the effectiveness of our cervical cancer screening strategy could be diminished.

I hope the authors will continue their study and compare the cryosurgical healing with that of loop excision. Reported complications are low for loop excision, but there have been no carefully done studies of patient-based experiences with it. It is important to establish the complete healing sequelae after loop excision and to measure patients’ disutilities in a similar fashion to the studies by Harper and colleagues.

The most important clinical observations from these 2 studies are the side effects of pain and cramping and protracted hydrorrhea. It is likely that these may influence future screening and treatment. If cryosurgery intervention for CIN 1 and its side effects limit future screening and treatment, more harm than good may be done by therapy. Clinicians need to consider the information Harper and coworkers have presented when choosing to recommend therapy.

Cryotherapy is an effective, affordable, and safe treatment for cervical dysplasia. Despite newer technologies such as laser and loop excision, cryotherapy continues to be commonly used when the colposcopy is satisfactory, the lesions are 2 or less quadrants of the cervix, no endocervical disease is present, and there is no suspicion of invasive cancer.

In this issue of the Journal, Harper and colleagues^1,2 have presented 2 studies of the natural history of side effects of cervical cryosurgery. They have documented several important points concerning the period immediately post-treatment that have clinical implications.Hydrorrhea is an expected finding after cryotherapy. These 2 papers document the long duration of hydrorrhea (mean=11.4 days, range=1 to 57 days) and its significant discomfort to patients. More than half of the women felt this side effect was bothersome, and 25% of the group characterized it as very or extremely so. Two thirds of the patients required medication in the postoperative period. The authors have also identified subgroups (obese, multiparous, and older patients) that are more likely to suffer from these complications.

These findings have clear-cut implications concerning informed consent before cryotherapy. Patients should be informed of the expected duration of the hydrorrhea and the postoperative analgesia that may be required. Obese, multiparous, and older women should be told that on average their postoperative course tends to be more severe. Some patients may request other treatment options. Those who choose cryotherapy as a treatment option may be reassured that their healing in the postoperative period is normal.

Future Research

The work by Harper and coworkers shows that quality of life is affected by cryosurgery treatment. Future research should be done to determine how diminished the quality-of-life utilities are. The decision to use cryosurgery versus an excisional method, such as the loop electrosurgical excision procedure, most likely hinges on the experience of the treatment procedure rather than the effectiveness of the procedure. Before any cost-effectiveness analysis of cervical dysplasia treatments can be completed, the quality-of-life measures for all treatment procedures must be delineated. Only then can the quality-adjusted effectiveness of the treatment procedures be compared. Implicit in the comparison of cryosurgery to loop excision is the assumption that both treatments are equally effective for the particular cervical lesion.

Cryosurgery is often used for treatment of cervical intraepithelial neoplasia grade 1 (CIN 1) lesions. We recognize that CIN 1 lesions are a manifestation of human papillomavirus infection and will regress to normal cervical tissue without intervention approximately 60% to 80% of the time. Using a destructive method for CIN 1 lesions that has significant sequelae should be studied in a cost-effective manner, taking into account the expressed quality of life. The cost-effectiveness analysis may show us that it is rational to conservatively manage women with CIN 1 for a year then treat with cryosurgery if the lesion is still present, or it may show that immediate treatment is most cost-effective. This important work is yet to be done.

In addition, it is anticipated that the compliance rate with future routine screening practices could be affected by the cervical treatment procedure chosen. If women do not return in a timely manner for rescreening after treatment because of the bad healing experience, the effectiveness of our cervical cancer screening strategy could be diminished.

I hope the authors will continue their study and compare the cryosurgical healing with that of loop excision. Reported complications are low for loop excision, but there have been no carefully done studies of patient-based experiences with it. It is important to establish the complete healing sequelae after loop excision and to measure patients’ disutilities in a similar fashion to the studies by Harper and colleagues.

The most important clinical observations from these 2 studies are the side effects of pain and cramping and protracted hydrorrhea. It is likely that these may influence future screening and treatment. If cryosurgery intervention for CIN 1 and its side effects limit future screening and treatment, more harm than good may be done by therapy. Clinicians need to consider the information Harper and coworkers have presented when choosing to recommend therapy.

Cryotherapy is an effective, affordable, and safe treatment for cervical dysplasia. Despite newer technologies such as laser and loop excision, cryotherapy continues to be commonly used when the colposcopy is satisfactory, the lesions are 2 or less quadrants of the cervix, no endocervical disease is present, and there is no suspicion of invasive cancer.

In this issue of the Journal, Harper and colleagues^1,2 have presented 2 studies of the natural history of side effects of cervical cryosurgery. They have documented several important points concerning the period immediately post-treatment that have clinical implications.Hydrorrhea is an expected finding after cryotherapy. These 2 papers document the long duration of hydrorrhea (mean=11.4 days, range=1 to 57 days) and its significant discomfort to patients. More than half of the women felt this side effect was bothersome, and 25% of the group characterized it as very or extremely so. Two thirds of the patients required medication in the postoperative period. The authors have also identified subgroups (obese, multiparous, and older patients) that are more likely to suffer from these complications.

These findings have clear-cut implications concerning informed consent before cryotherapy. Patients should be informed of the expected duration of the hydrorrhea and the postoperative analgesia that may be required. Obese, multiparous, and older women should be told that on average their postoperative course tends to be more severe. Some patients may request other treatment options. Those who choose cryotherapy as a treatment option may be reassured that their healing in the postoperative period is normal.

Future Research

The work by Harper and coworkers shows that quality of life is affected by cryosurgery treatment. Future research should be done to determine how diminished the quality-of-life utilities are. The decision to use cryosurgery versus an excisional method, such as the loop electrosurgical excision procedure, most likely hinges on the experience of the treatment procedure rather than the effectiveness of the procedure. Before any cost-effectiveness analysis of cervical dysplasia treatments can be completed, the quality-of-life measures for all treatment procedures must be delineated. Only then can the quality-adjusted effectiveness of the treatment procedures be compared. Implicit in the comparison of cryosurgery to loop excision is the assumption that both treatments are equally effective for the particular cervical lesion.

Cryosurgery is often used for treatment of cervical intraepithelial neoplasia grade 1 (CIN 1) lesions. We recognize that CIN 1 lesions are a manifestation of human papillomavirus infection and will regress to normal cervical tissue without intervention approximately 60% to 80% of the time. Using a destructive method for CIN 1 lesions that has significant sequelae should be studied in a cost-effective manner, taking into account the expressed quality of life. The cost-effectiveness analysis may show us that it is rational to conservatively manage women with CIN 1 for a year then treat with cryosurgery if the lesion is still present, or it may show that immediate treatment is most cost-effective. This important work is yet to be done.

In addition, it is anticipated that the compliance rate with future routine screening practices could be affected by the cervical treatment procedure chosen. If women do not return in a timely manner for rescreening after treatment because of the bad healing experience, the effectiveness of our cervical cancer screening strategy could be diminished.

I hope the authors will continue their study and compare the cryosurgical healing with that of loop excision. Reported complications are low for loop excision, but there have been no carefully done studies of patient-based experiences with it. It is important to establish the complete healing sequelae after loop excision and to measure patients’ disutilities in a similar fashion to the studies by Harper and colleagues.

The most important clinical observations from these 2 studies are the side effects of pain and cramping and protracted hydrorrhea. It is likely that these may influence future screening and treatment. If cryosurgery intervention for CIN 1 and its side effects limit future screening and treatment, more harm than good may be done by therapy. Clinicians need to consider the information Harper and coworkers have presented when choosing to recommend therapy.