Diane M. Harper, MD, MPH

Women experience discomfort during treatment for cervical intraepithelial neoplasia (CIN). The discomfort from cryosurgery has been studied and is usually alleviated by the use of nonsteroidal anti-inflammatory drugs (NSAIDs) and mucosal blocks before the procedure.^1-4 Pain and cramping alleviation is cost-effective.⁵ The cryosurgical healing process includes malodorous hydrorrhea (watery discharge) that lasts 12 days on average, but can continue for an entire month.⁶ Specific populations of women who are potentially more bothered by the healing process include those who are obese, nulligravid, and younger. Each of these subsets can experience more dysmenorrhea than their clinical counterparts.^7,8

Obese women, in general, do not present for cervical cancer screenings as often as those who are not obese, because of lower self-esteem.⁹ All women’s experiences and those specific to these 3 groups have not previously been described for cryosurgical healing. Women’s perspectives and experiences with the healing process might influence their compliance with future cervical cancer screenings and treatments.

The purpose of our study was to describe women’s experiences after cryosurgery, particularly in relationship with obesity, gravidity, and age. We postulated that women who were obese, nulligravid, and younger would experience a more unpleasant healing process after cryosurgery than those who were nonobese, multigravid, and older. The experience following cryosurgery was compared with the experience of normal menses, and factors for women’s future treatment decisions were ranked in order of importance.

Methods

Survey Instrument

We designed a survey in 1995 to measure a woman’s experiences with the healing process of cryosurgery. The survey was developed from the results of a focus group of 8 women who had previously experienced cryosurgery. Validity and clarity were established by test-retest comparisons in a second group of women with cryosurgical experience. The survey consisted of 2 fixed-response questions, 8 open-ended questions, ¹⁰ dichotomous (yes/no) questions, and 16 5-point Likert-scaled questions. All items gauged the study participants’ experiences following cryosurgery and included questions regarding: the unpleasantness of the healing process, the bother of the hydrorrhea produced from the procedure, the frequency of pad protection required postprocedure, and the intensity of the malodorous hydrorrhea. Women were asked to compare their subjective experiences of menses with their postprocedure experiences in the following categories: use and frequency of pad protection, medication usage, and activity restriction due to hydrorrhea volume. The subjects were also asked to rank which factors were important to them in making their decision for future treatment. The respective institutional review boards or human subjects committees at each of the clinical sites approved the study.

Sample Population

All women who participated in our study had undergone a cryosurgical procedure for histologically proven CIN grade 1, 2, or 3 disease. All demographic information needed for analysis was collected at the time of cryosurgery. The power of our study was designed to detect a difference in experiences from cryosurgery compared with normal menses. Specifically, the study has a 95% power to detect a 20% difference in the proportion of women taking medications to alleviate symptoms and having activity restrictions from cryosurgery compared with normal menses at the P=.05 level of significance. Obesity and age subsets of the population were also powered to 80% to detect a 35% difference in the proportion of women taking medications and having activity restrictions from cryosurgery compared with normal menses at the P=.05 level of significance. The gravidity subset was powered to 80% to detect a 45% difference in the same outcome measures at the P=.05 level of significance.

Study Methods

All women who underwent cryosurgery were mailed a questionnaire and cover letter with instructions to return the survey in an enclosed self-addressed, stamped envelope. If the survey was not returned within 3 weeks the research assistant at each clinical site invited the woman to complete it when she presented for the next scheduled follow-up visit.

Data Analysis

Obesity, gravidity, and age were modeled as both continuous and dichotomous variables. Dichotomous definitions included obesity as a body mass index (BMI) of 26 kg/m² or greater,¹⁰ nulligravidity as no pregnancies, and young age as less than 26 years, as most CIN develops in college-aged or younger sexually active women.¹¹

All survey responses were coded and entered into Statistica software (Statsoft, Tulsa, Okla) for descriptive frequency analyses, chi-square testing of dichotomous variables, Likert scale means testing by the t test for independent variables, and Pearson correlation coefficients. Casewise deletion was not used to eliminate partial responses in the analysis.

Results

Of the 85 women who participated in the study, 72 completed the survey for a response rate of 84.7%. The mean time from the cryosurgical procedure to completion of the survey was 11.4 days (standard deviation [SD]=14.4), with a range of 1 to 57 days paralleling the cessation time for hydrorrhea. All women answered 27% of the questions, and 28% of women answered all of the questions. There was no pattern of nonresponse. [Table 1] shows the characteristics of the women who participated in the survey.

The cryosurgical healing process was unpleasant for 78.3% (54/69) of the women because of the pain and cramping following the procedure and the resulting hydrorrhea, odor, and necessity of wearing pads for protection. Of all the women, 8.7% felt neutral toward the experience, and 13% considered the experience positive. Even though unpleasant, only 53.5% (38/71) reported that the hydrorrhea was bothersome to them, and of those, 47.4% (18/38) quantified the hydrorrhea as very or extremely bothersome. Of all the women, 61.1% (44/72) responded affirmatively to the dichotomous question that wearing pads was bothersome, and of those, 34.1% (15/44) quantified the degree of inconvenience as very or extremely bothersome. Of all the subjects, 51.4% (37/72) stated that there was a foul to very foul odor associated with the hydrorrhea. Detailed frequencies and the mean Likert score intensities are displayed in [Table 2].

[Table 3] shows the comparisons of the cryosurgical healing process to normal menses. Of all the women, 66.7% (48/72) used pads for their menses. Of these, 61.7% ranked the use of the pads after cryosurgery as the same or less aggravating than those for their menses, and 51.1% (24/47) felt the frequency of pad changes required was more or much more than with normal menses. Of all the women, 52.8% (38/72) ranked the volume of hydrorrhea after cryosurgery as more or much more than with their menses.

Women who experienced light menstrual volumes perceived significantly more hydrorrhea from cryosurgery, while women who experienced heavy menstrual flow experienced significantly less hydrorrhea from cryosurgery. Of all the women, 56.3% felt that their experience with cryosurgery restricted their activities more than their normal menses. The restrictions were described through open-ended questions for at least one of 5 reasons: (1) social embarrassment due to overflowing and malodorous hydrorrhea; (2) concern for impairment of the healing process if normal activities, such as lifting, were resumed; (3) the abdominal and pelvic discomfort that continued for days after the procedure; (4) the inability to sleep at night because of the overflow of hydrorrhea; and (5) the physician-imposed limitations of no vaginal intercourse.

Medications for menstrual cramps were taken by 26.8% of the women, while after cryosurgery 67.1% of women reported taking medication (chi-square=23.09; P <.0001). Only 16.9% of the women stated that they were restricted in their activities because of their menses, while 38.6% stated they were limited by the hydrorrhea from the cryosurgery (chi-square=8.27, P=.004).

[Table 4] has the mean of the experiences with the cryosurgical healing process from the 3 subsets of women. For all 3 population subsets-those with obesity, younger age, and nulligravidity-the cryosurgical healing process results in significantly more medications being taken and activities restricted significantly more than for menses (obese: P=.0246; nonobese: P=.0043; multigravid: P=.0061; young: P=.0014; old: P=.001), an association seen for the general population. Activity restrictions were greater for the healing process than for menses for each of these respective groups of women (obese: P=.0018; nonobese: P=.0037; multigravid: P=.0084; young: P=.0500; old: P=.0419).

Obese women whose BMI was greater than 26 kg/m² were significantly more bothered by wearing pads after cryosurgery than those with a lesser BMI (t=2.33, P=.0246). Multigravid women were more likely to be bothered or aggravated by wearing pads than nulligravid women (t=2.88, P=.0061). Similarly, women older than 26 years were more likely to be bothered by pad use than younger women (t=2.14, P=.0383). In the group of women aged 26 years or younger we found that those aged 15 to 18 years were significantly less bothered about the hydrorrhea than those in the 19 to 22 years cohort (1.0 vs 3.4, t=3.35, P=.0122), considered the frequency of pad changes to be less aggravating than menses than the 19 to 22 years cohort (2.67 vs 4.0, t=3.65, P=.0020), but considered the hydrorrhea more malodorous than those aged 19 to 22 years (4.3 vs 3.2, t=2.33, P=.0325).

More women ranked the number of days experiencing pain and cramping during the cryosurgery procedure as the most important factor in their decision to undergo future treatment (42.9%). It was not significantly more important than the amount of hydrorrhea subsequent to the procedure (37.1%) or the cost of the procedure (20.0%). All 3 factors-pain and cramping, hydrorrhea, and cost-were considered equally important by 7.9% in their decision for future treatment, while 22.2% felt that only the pain and cramping and the volume of hydrorrhea were important to consider for future treatment.

Discussion

Physicians have traditionally focused on relieving the pain and cramping of the cryosurgical procedure itself^1-5 and have paid less attention to the healing process. Among all aspects of the healing process, women care most about the pain and cramping but are also were bothered by the resulting hydrorrhea, odor, and necessity of wearing pads for protection. Few women were extremely bothered by the healing process; most ranked it as moderately bothersome, requiring more medications, and limiting activities more than normal menses. A small number of women found the procedure to be a positive experience. No similar study has been done for loop electrosurgery or laser surgery.

Our study documents that 16.9% of women were restricted in their daily activities by their menses. This proportion of our study population is slightly higher than Sundell’s report of 10% of 24-year-old women who were restricted in their activities because of dysmenorrhea.⁷ Menses causes significantly fewer days of activity restriction than the cryosurgical experience. Andersch and Milsom¹³ report that 38.1% of women use medications for dysmenorrhea, somewhat higher than our 26.8%. Both of these are clinically and statistically less than the almost 70% medication use for the cryosurgical healing process.

The 3 subsets of the population we examined were obese, nulligravid, and young. Obese women were stratified in the analysis because they are screened less often for cervical cancer,^9,14-21 experience more dysmenorrhea cyclically,⁷ and take more medications for dysmenorrhea than nonobese women.⁸ Unpleasant experiences from cryosurgery could exacerbate the pattern of nonscreening in the future. Our study showed that obese women were more bothered by pad use than nonobese women but were not more restricted in their activities after cryosurgery. Previous work has shown that obese women produce more hydrorrhea quantitatively postprocedure than nonobese women.⁶ Our work shows that the obese women are not bothered by the hydrorrhea itself but by the necessity of wearing pads for protection.

Young and nulligravid subsets of the population have been found to experience more dysmenorrhea than older and multigravid women.⁷ These subsets of women, if sexually active, are also at high risk for human papillomavirus infection and subsequent CIN development, possibly requiring treatment. Surprisingly, in our study the youngest teens (15-18 years) were only bothered by the malodorous hy-drorrhea more than their counterparts aged 19 to 22 years and were less bothered by the hydrorrhea itself and the frequency of pad changes. Our study showed that older and multigravid woman rank the inconvenience of pad use after the cryosurgical procedure as worse than their clinical counterparts, potentially because these women had more daily responsibilities that were interrupted by the necessary pad changes.

The importance of our study is twofold. First, cryosurgery is a valuable treatment modality for all grades of CIN with lesions that meet the specific requirements. To set the patient’s expectations about the healing process following cryosurgery, patient education and informed consent should include, in addition to the description of the procedure, its necessity, and the standard Papanicolaou test follow-up, the comparison of cryosurgery with the woman’s menses, covering the points established by our study: (1) the volume of hydrorrhea will be perceived inversely to the volume of menses; (2) more activity restrictions occur; and (3) more medications are needed to alleviate cramping. Additionally, obese, older, and multigravid women experienced more aggravation from the pad use than others, and the youngest teens were more bothered by the malodorous hydrorrhea. Second, many physicians will treat CIN 1 lesions without allowing the lesion to undergo natural regression.²² By being this aggressive, the physician must weigh the quicker time that would have occurred without treatment to lesion regression caused by the cryosurgery with the risks of a bad cryosurgery experience that may affect future screening practices.

Decisions to undergo future CIN treatment were most influenced by the pain and cramping and the hydrorrhea of cryosurgery. It is unknown whether or when women will return for yearly preventive screening after experiencing cryosurgery. Winkler²³ reported that women who underwent bilateral tubal ligations who later developed cervical cancer had more than a 6-year time lapse before returning for cervical cancer screening, longer than the 4 years for those women without tubal ligations. Future work will explore the influence of the cryosurgical experience on compliance with future screenings and will include formal disutility measurements due to cryosurgical treatment.

Acknowledgments

Our work was supported in part by the Robert Wood Johnson Foundation (D.M.H).

Women experience discomfort during treatment for cervical intraepithelial neoplasia (CIN). The discomfort from cryosurgery has been studied and is usually alleviated by the use of nonsteroidal anti-inflammatory drugs (NSAIDs) and mucosal blocks before the procedure.^1-4 Pain and cramping alleviation is cost-effective.⁵ The cryosurgical healing process includes malodorous hydrorrhea (watery discharge) that lasts 12 days on average, but can continue for an entire month.⁶ Specific populations of women who are potentially more bothered by the healing process include those who are obese, nulligravid, and younger. Each of these subsets can experience more dysmenorrhea than their clinical counterparts.^7,8

Obese women, in general, do not present for cervical cancer screenings as often as those who are not obese, because of lower self-esteem.⁹ All women’s experiences and those specific to these 3 groups have not previously been described for cryosurgical healing. Women’s perspectives and experiences with the healing process might influence their compliance with future cervical cancer screenings and treatments.

The purpose of our study was to describe women’s experiences after cryosurgery, particularly in relationship with obesity, gravidity, and age. We postulated that women who were obese, nulligravid, and younger would experience a more unpleasant healing process after cryosurgery than those who were nonobese, multigravid, and older. The experience following cryosurgery was compared with the experience of normal menses, and factors for women’s future treatment decisions were ranked in order of importance.

Methods

Survey Instrument

We designed a survey in 1995 to measure a woman’s experiences with the healing process of cryosurgery. The survey was developed from the results of a focus group of 8 women who had previously experienced cryosurgery. Validity and clarity were established by test-retest comparisons in a second group of women with cryosurgical experience. The survey consisted of 2 fixed-response questions, 8 open-ended questions, ¹⁰ dichotomous (yes/no) questions, and 16 5-point Likert-scaled questions. All items gauged the study participants’ experiences following cryosurgery and included questions regarding: the unpleasantness of the healing process, the bother of the hydrorrhea produced from the procedure, the frequency of pad protection required postprocedure, and the intensity of the malodorous hydrorrhea. Women were asked to compare their subjective experiences of menses with their postprocedure experiences in the following categories: use and frequency of pad protection, medication usage, and activity restriction due to hydrorrhea volume. The subjects were also asked to rank which factors were important to them in making their decision for future treatment. The respective institutional review boards or human subjects committees at each of the clinical sites approved the study.

Sample Population

All women who participated in our study had undergone a cryosurgical procedure for histologically proven CIN grade 1, 2, or 3 disease. All demographic information needed for analysis was collected at the time of cryosurgery. The power of our study was designed to detect a difference in experiences from cryosurgery compared with normal menses. Specifically, the study has a 95% power to detect a 20% difference in the proportion of women taking medications to alleviate symptoms and having activity restrictions from cryosurgery compared with normal menses at the P=.05 level of significance. Obesity and age subsets of the population were also powered to 80% to detect a 35% difference in the proportion of women taking medications and having activity restrictions from cryosurgery compared with normal menses at the P=.05 level of significance. The gravidity subset was powered to 80% to detect a 45% difference in the same outcome measures at the P=.05 level of significance.

Study Methods

All women who underwent cryosurgery were mailed a questionnaire and cover letter with instructions to return the survey in an enclosed self-addressed, stamped envelope. If the survey was not returned within 3 weeks the research assistant at each clinical site invited the woman to complete it when she presented for the next scheduled follow-up visit.

Data Analysis

Obesity, gravidity, and age were modeled as both continuous and dichotomous variables. Dichotomous definitions included obesity as a body mass index (BMI) of 26 kg/m² or greater,¹⁰ nulligravidity as no pregnancies, and young age as less than 26 years, as most CIN develops in college-aged or younger sexually active women.¹¹

All survey responses were coded and entered into Statistica software (Statsoft, Tulsa, Okla) for descriptive frequency analyses, chi-square testing of dichotomous variables, Likert scale means testing by the t test for independent variables, and Pearson correlation coefficients. Casewise deletion was not used to eliminate partial responses in the analysis.

Results

Of the 85 women who participated in the study, 72 completed the survey for a response rate of 84.7%. The mean time from the cryosurgical procedure to completion of the survey was 11.4 days (standard deviation [SD]=14.4), with a range of 1 to 57 days paralleling the cessation time for hydrorrhea. All women answered 27% of the questions, and 28% of women answered all of the questions. There was no pattern of nonresponse. [Table 1] shows the characteristics of the women who participated in the survey.

The cryosurgical healing process was unpleasant for 78.3% (54/69) of the women because of the pain and cramping following the procedure and the resulting hydrorrhea, odor, and necessity of wearing pads for protection. Of all the women, 8.7% felt neutral toward the experience, and 13% considered the experience positive. Even though unpleasant, only 53.5% (38/71) reported that the hydrorrhea was bothersome to them, and of those, 47.4% (18/38) quantified the hydrorrhea as very or extremely bothersome. Of all the women, 61.1% (44/72) responded affirmatively to the dichotomous question that wearing pads was bothersome, and of those, 34.1% (15/44) quantified the degree of inconvenience as very or extremely bothersome. Of all the subjects, 51.4% (37/72) stated that there was a foul to very foul odor associated with the hydrorrhea. Detailed frequencies and the mean Likert score intensities are displayed in [Table 2].

[Table 3] shows the comparisons of the cryosurgical healing process to normal menses. Of all the women, 66.7% (48/72) used pads for their menses. Of these, 61.7% ranked the use of the pads after cryosurgery as the same or less aggravating than those for their menses, and 51.1% (24/47) felt the frequency of pad changes required was more or much more than with normal menses. Of all the women, 52.8% (38/72) ranked the volume of hydrorrhea after cryosurgery as more or much more than with their menses.

Women who experienced light menstrual volumes perceived significantly more hydrorrhea from cryosurgery, while women who experienced heavy menstrual flow experienced significantly less hydrorrhea from cryosurgery. Of all the women, 56.3% felt that their experience with cryosurgery restricted their activities more than their normal menses. The restrictions were described through open-ended questions for at least one of 5 reasons: (1) social embarrassment due to overflowing and malodorous hydrorrhea; (2) concern for impairment of the healing process if normal activities, such as lifting, were resumed; (3) the abdominal and pelvic discomfort that continued for days after the procedure; (4) the inability to sleep at night because of the overflow of hydrorrhea; and (5) the physician-imposed limitations of no vaginal intercourse.

Medications for menstrual cramps were taken by 26.8% of the women, while after cryosurgery 67.1% of women reported taking medication (chi-square=23.09; P <.0001). Only 16.9% of the women stated that they were restricted in their activities because of their menses, while 38.6% stated they were limited by the hydrorrhea from the cryosurgery (chi-square=8.27, P=.004).

[Table 4] has the mean of the experiences with the cryosurgical healing process from the 3 subsets of women. For all 3 population subsets-those with obesity, younger age, and nulligravidity-the cryosurgical healing process results in significantly more medications being taken and activities restricted significantly more than for menses (obese: P=.0246; nonobese: P=.0043; multigravid: P=.0061; young: P=.0014; old: P=.001), an association seen for the general population. Activity restrictions were greater for the healing process than for menses for each of these respective groups of women (obese: P=.0018; nonobese: P=.0037; multigravid: P=.0084; young: P=.0500; old: P=.0419).

Obese women whose BMI was greater than 26 kg/m² were significantly more bothered by wearing pads after cryosurgery than those with a lesser BMI (t=2.33, P=.0246). Multigravid women were more likely to be bothered or aggravated by wearing pads than nulligravid women (t=2.88, P=.0061). Similarly, women older than 26 years were more likely to be bothered by pad use than younger women (t=2.14, P=.0383). In the group of women aged 26 years or younger we found that those aged 15 to 18 years were significantly less bothered about the hydrorrhea than those in the 19 to 22 years cohort (1.0 vs 3.4, t=3.35, P=.0122), considered the frequency of pad changes to be less aggravating than menses than the 19 to 22 years cohort (2.67 vs 4.0, t=3.65, P=.0020), but considered the hydrorrhea more malodorous than those aged 19 to 22 years (4.3 vs 3.2, t=2.33, P=.0325).

More women ranked the number of days experiencing pain and cramping during the cryosurgery procedure as the most important factor in their decision to undergo future treatment (42.9%). It was not significantly more important than the amount of hydrorrhea subsequent to the procedure (37.1%) or the cost of the procedure (20.0%). All 3 factors-pain and cramping, hydrorrhea, and cost-were considered equally important by 7.9% in their decision for future treatment, while 22.2% felt that only the pain and cramping and the volume of hydrorrhea were important to consider for future treatment.

Discussion

Physicians have traditionally focused on relieving the pain and cramping of the cryosurgical procedure itself^1-5 and have paid less attention to the healing process. Among all aspects of the healing process, women care most about the pain and cramping but are also were bothered by the resulting hydrorrhea, odor, and necessity of wearing pads for protection. Few women were extremely bothered by the healing process; most ranked it as moderately bothersome, requiring more medications, and limiting activities more than normal menses. A small number of women found the procedure to be a positive experience. No similar study has been done for loop electrosurgery or laser surgery.

Our study documents that 16.9% of women were restricted in their daily activities by their menses. This proportion of our study population is slightly higher than Sundell’s report of 10% of 24-year-old women who were restricted in their activities because of dysmenorrhea.⁷ Menses causes significantly fewer days of activity restriction than the cryosurgical experience. Andersch and Milsom¹³ report that 38.1% of women use medications for dysmenorrhea, somewhat higher than our 26.8%. Both of these are clinically and statistically less than the almost 70% medication use for the cryosurgical healing process.

The 3 subsets of the population we examined were obese, nulligravid, and young. Obese women were stratified in the analysis because they are screened less often for cervical cancer,^9,14-21 experience more dysmenorrhea cyclically,⁷ and take more medications for dysmenorrhea than nonobese women.⁸ Unpleasant experiences from cryosurgery could exacerbate the pattern of nonscreening in the future. Our study showed that obese women were more bothered by pad use than nonobese women but were not more restricted in their activities after cryosurgery. Previous work has shown that obese women produce more hydrorrhea quantitatively postprocedure than nonobese women.⁶ Our work shows that the obese women are not bothered by the hydrorrhea itself but by the necessity of wearing pads for protection.

Young and nulligravid subsets of the population have been found to experience more dysmenorrhea than older and multigravid women.⁷ These subsets of women, if sexually active, are also at high risk for human papillomavirus infection and subsequent CIN development, possibly requiring treatment. Surprisingly, in our study the youngest teens (15-18 years) were only bothered by the malodorous hy-drorrhea more than their counterparts aged 19 to 22 years and were less bothered by the hydrorrhea itself and the frequency of pad changes. Our study showed that older and multigravid woman rank the inconvenience of pad use after the cryosurgical procedure as worse than their clinical counterparts, potentially because these women had more daily responsibilities that were interrupted by the necessary pad changes.

The importance of our study is twofold. First, cryosurgery is a valuable treatment modality for all grades of CIN with lesions that meet the specific requirements. To set the patient’s expectations about the healing process following cryosurgery, patient education and informed consent should include, in addition to the description of the procedure, its necessity, and the standard Papanicolaou test follow-up, the comparison of cryosurgery with the woman’s menses, covering the points established by our study: (1) the volume of hydrorrhea will be perceived inversely to the volume of menses; (2) more activity restrictions occur; and (3) more medications are needed to alleviate cramping. Additionally, obese, older, and multigravid women experienced more aggravation from the pad use than others, and the youngest teens were more bothered by the malodorous hydrorrhea. Second, many physicians will treat CIN 1 lesions without allowing the lesion to undergo natural regression.²² By being this aggressive, the physician must weigh the quicker time that would have occurred without treatment to lesion regression caused by the cryosurgery with the risks of a bad cryosurgery experience that may affect future screening practices.

Decisions to undergo future CIN treatment were most influenced by the pain and cramping and the hydrorrhea of cryosurgery. It is unknown whether or when women will return for yearly preventive screening after experiencing cryosurgery. Winkler²³ reported that women who underwent bilateral tubal ligations who later developed cervical cancer had more than a 6-year time lapse before returning for cervical cancer screening, longer than the 4 years for those women without tubal ligations. Future work will explore the influence of the cryosurgical experience on compliance with future screenings and will include formal disutility measurements due to cryosurgical treatment.

Acknowledgments

Our work was supported in part by the Robert Wood Johnson Foundation (D.M.H).

Women experience discomfort during treatment for cervical intraepithelial neoplasia (CIN). The discomfort from cryosurgery has been studied and is usually alleviated by the use of nonsteroidal anti-inflammatory drugs (NSAIDs) and mucosal blocks before the procedure.^1-4 Pain and cramping alleviation is cost-effective.⁵ The cryosurgical healing process includes malodorous hydrorrhea (watery discharge) that lasts 12 days on average, but can continue for an entire month.⁶ Specific populations of women who are potentially more bothered by the healing process include those who are obese, nulligravid, and younger. Each of these subsets can experience more dysmenorrhea than their clinical counterparts.^7,8

Obese women, in general, do not present for cervical cancer screenings as often as those who are not obese, because of lower self-esteem.⁹ All women’s experiences and those specific to these 3 groups have not previously been described for cryosurgical healing. Women’s perspectives and experiences with the healing process might influence their compliance with future cervical cancer screenings and treatments.

The purpose of our study was to describe women’s experiences after cryosurgery, particularly in relationship with obesity, gravidity, and age. We postulated that women who were obese, nulligravid, and younger would experience a more unpleasant healing process after cryosurgery than those who were nonobese, multigravid, and older. The experience following cryosurgery was compared with the experience of normal menses, and factors for women’s future treatment decisions were ranked in order of importance.

Methods

Survey Instrument

We designed a survey in 1995 to measure a woman’s experiences with the healing process of cryosurgery. The survey was developed from the results of a focus group of 8 women who had previously experienced cryosurgery. Validity and clarity were established by test-retest comparisons in a second group of women with cryosurgical experience. The survey consisted of 2 fixed-response questions, 8 open-ended questions, ¹⁰ dichotomous (yes/no) questions, and 16 5-point Likert-scaled questions. All items gauged the study participants’ experiences following cryosurgery and included questions regarding: the unpleasantness of the healing process, the bother of the hydrorrhea produced from the procedure, the frequency of pad protection required postprocedure, and the intensity of the malodorous hydrorrhea. Women were asked to compare their subjective experiences of menses with their postprocedure experiences in the following categories: use and frequency of pad protection, medication usage, and activity restriction due to hydrorrhea volume. The subjects were also asked to rank which factors were important to them in making their decision for future treatment. The respective institutional review boards or human subjects committees at each of the clinical sites approved the study.

Sample Population

All women who participated in our study had undergone a cryosurgical procedure for histologically proven CIN grade 1, 2, or 3 disease. All demographic information needed for analysis was collected at the time of cryosurgery. The power of our study was designed to detect a difference in experiences from cryosurgery compared with normal menses. Specifically, the study has a 95% power to detect a 20% difference in the proportion of women taking medications to alleviate symptoms and having activity restrictions from cryosurgery compared with normal menses at the P=.05 level of significance. Obesity and age subsets of the population were also powered to 80% to detect a 35% difference in the proportion of women taking medications and having activity restrictions from cryosurgery compared with normal menses at the P=.05 level of significance. The gravidity subset was powered to 80% to detect a 45% difference in the same outcome measures at the P=.05 level of significance.

Study Methods

All women who underwent cryosurgery were mailed a questionnaire and cover letter with instructions to return the survey in an enclosed self-addressed, stamped envelope. If the survey was not returned within 3 weeks the research assistant at each clinical site invited the woman to complete it when she presented for the next scheduled follow-up visit.

Data Analysis

Obesity, gravidity, and age were modeled as both continuous and dichotomous variables. Dichotomous definitions included obesity as a body mass index (BMI) of 26 kg/m² or greater,¹⁰ nulligravidity as no pregnancies, and young age as less than 26 years, as most CIN develops in college-aged or younger sexually active women.¹¹

All survey responses were coded and entered into Statistica software (Statsoft, Tulsa, Okla) for descriptive frequency analyses, chi-square testing of dichotomous variables, Likert scale means testing by the t test for independent variables, and Pearson correlation coefficients. Casewise deletion was not used to eliminate partial responses in the analysis.

Results

Of the 85 women who participated in the study, 72 completed the survey for a response rate of 84.7%. The mean time from the cryosurgical procedure to completion of the survey was 11.4 days (standard deviation [SD]=14.4), with a range of 1 to 57 days paralleling the cessation time for hydrorrhea. All women answered 27% of the questions, and 28% of women answered all of the questions. There was no pattern of nonresponse. [Table 1] shows the characteristics of the women who participated in the survey.

The cryosurgical healing process was unpleasant for 78.3% (54/69) of the women because of the pain and cramping following the procedure and the resulting hydrorrhea, odor, and necessity of wearing pads for protection. Of all the women, 8.7% felt neutral toward the experience, and 13% considered the experience positive. Even though unpleasant, only 53.5% (38/71) reported that the hydrorrhea was bothersome to them, and of those, 47.4% (18/38) quantified the hydrorrhea as very or extremely bothersome. Of all the women, 61.1% (44/72) responded affirmatively to the dichotomous question that wearing pads was bothersome, and of those, 34.1% (15/44) quantified the degree of inconvenience as very or extremely bothersome. Of all the subjects, 51.4% (37/72) stated that there was a foul to very foul odor associated with the hydrorrhea. Detailed frequencies and the mean Likert score intensities are displayed in [Table 2].

[Table 3] shows the comparisons of the cryosurgical healing process to normal menses. Of all the women, 66.7% (48/72) used pads for their menses. Of these, 61.7% ranked the use of the pads after cryosurgery as the same or less aggravating than those for their menses, and 51.1% (24/47) felt the frequency of pad changes required was more or much more than with normal menses. Of all the women, 52.8% (38/72) ranked the volume of hydrorrhea after cryosurgery as more or much more than with their menses.

Women who experienced light menstrual volumes perceived significantly more hydrorrhea from cryosurgery, while women who experienced heavy menstrual flow experienced significantly less hydrorrhea from cryosurgery. Of all the women, 56.3% felt that their experience with cryosurgery restricted their activities more than their normal menses. The restrictions were described through open-ended questions for at least one of 5 reasons: (1) social embarrassment due to overflowing and malodorous hydrorrhea; (2) concern for impairment of the healing process if normal activities, such as lifting, were resumed; (3) the abdominal and pelvic discomfort that continued for days after the procedure; (4) the inability to sleep at night because of the overflow of hydrorrhea; and (5) the physician-imposed limitations of no vaginal intercourse.

Medications for menstrual cramps were taken by 26.8% of the women, while after cryosurgery 67.1% of women reported taking medication (chi-square=23.09; P <.0001). Only 16.9% of the women stated that they were restricted in their activities because of their menses, while 38.6% stated they were limited by the hydrorrhea from the cryosurgery (chi-square=8.27, P=.004).

[Table 4] has the mean of the experiences with the cryosurgical healing process from the 3 subsets of women. For all 3 population subsets-those with obesity, younger age, and nulligravidity-the cryosurgical healing process results in significantly more medications being taken and activities restricted significantly more than for menses (obese: P=.0246; nonobese: P=.0043; multigravid: P=.0061; young: P=.0014; old: P=.001), an association seen for the general population. Activity restrictions were greater for the healing process than for menses for each of these respective groups of women (obese: P=.0018; nonobese: P=.0037; multigravid: P=.0084; young: P=.0500; old: P=.0419).

Obese women whose BMI was greater than 26 kg/m² were significantly more bothered by wearing pads after cryosurgery than those with a lesser BMI (t=2.33, P=.0246). Multigravid women were more likely to be bothered or aggravated by wearing pads than nulligravid women (t=2.88, P=.0061). Similarly, women older than 26 years were more likely to be bothered by pad use than younger women (t=2.14, P=.0383). In the group of women aged 26 years or younger we found that those aged 15 to 18 years were significantly less bothered about the hydrorrhea than those in the 19 to 22 years cohort (1.0 vs 3.4, t=3.35, P=.0122), considered the frequency of pad changes to be less aggravating than menses than the 19 to 22 years cohort (2.67 vs 4.0, t=3.65, P=.0020), but considered the hydrorrhea more malodorous than those aged 19 to 22 years (4.3 vs 3.2, t=2.33, P=.0325).

More women ranked the number of days experiencing pain and cramping during the cryosurgery procedure as the most important factor in their decision to undergo future treatment (42.9%). It was not significantly more important than the amount of hydrorrhea subsequent to the procedure (37.1%) or the cost of the procedure (20.0%). All 3 factors-pain and cramping, hydrorrhea, and cost-were considered equally important by 7.9% in their decision for future treatment, while 22.2% felt that only the pain and cramping and the volume of hydrorrhea were important to consider for future treatment.

Discussion

Physicians have traditionally focused on relieving the pain and cramping of the cryosurgical procedure itself^1-5 and have paid less attention to the healing process. Among all aspects of the healing process, women care most about the pain and cramping but are also were bothered by the resulting hydrorrhea, odor, and necessity of wearing pads for protection. Few women were extremely bothered by the healing process; most ranked it as moderately bothersome, requiring more medications, and limiting activities more than normal menses. A small number of women found the procedure to be a positive experience. No similar study has been done for loop electrosurgery or laser surgery.

Our study documents that 16.9% of women were restricted in their daily activities by their menses. This proportion of our study population is slightly higher than Sundell’s report of 10% of 24-year-old women who were restricted in their activities because of dysmenorrhea.⁷ Menses causes significantly fewer days of activity restriction than the cryosurgical experience. Andersch and Milsom¹³ report that 38.1% of women use medications for dysmenorrhea, somewhat higher than our 26.8%. Both of these are clinically and statistically less than the almost 70% medication use for the cryosurgical healing process.

The 3 subsets of the population we examined were obese, nulligravid, and young. Obese women were stratified in the analysis because they are screened less often for cervical cancer,^9,14-21 experience more dysmenorrhea cyclically,⁷ and take more medications for dysmenorrhea than nonobese women.⁸ Unpleasant experiences from cryosurgery could exacerbate the pattern of nonscreening in the future. Our study showed that obese women were more bothered by pad use than nonobese women but were not more restricted in their activities after cryosurgery. Previous work has shown that obese women produce more hydrorrhea quantitatively postprocedure than nonobese women.⁶ Our work shows that the obese women are not bothered by the hydrorrhea itself but by the necessity of wearing pads for protection.

Young and nulligravid subsets of the population have been found to experience more dysmenorrhea than older and multigravid women.⁷ These subsets of women, if sexually active, are also at high risk for human papillomavirus infection and subsequent CIN development, possibly requiring treatment. Surprisingly, in our study the youngest teens (15-18 years) were only bothered by the malodorous hy-drorrhea more than their counterparts aged 19 to 22 years and were less bothered by the hydrorrhea itself and the frequency of pad changes. Our study showed that older and multigravid woman rank the inconvenience of pad use after the cryosurgical procedure as worse than their clinical counterparts, potentially because these women had more daily responsibilities that were interrupted by the necessary pad changes.

The importance of our study is twofold. First, cryosurgery is a valuable treatment modality for all grades of CIN with lesions that meet the specific requirements. To set the patient’s expectations about the healing process following cryosurgery, patient education and informed consent should include, in addition to the description of the procedure, its necessity, and the standard Papanicolaou test follow-up, the comparison of cryosurgery with the woman’s menses, covering the points established by our study: (1) the volume of hydrorrhea will be perceived inversely to the volume of menses; (2) more activity restrictions occur; and (3) more medications are needed to alleviate cramping. Additionally, obese, older, and multigravid women experienced more aggravation from the pad use than others, and the youngest teens were more bothered by the malodorous hydrorrhea. Second, many physicians will treat CIN 1 lesions without allowing the lesion to undergo natural regression.²² By being this aggressive, the physician must weigh the quicker time that would have occurred without treatment to lesion regression caused by the cryosurgery with the risks of a bad cryosurgery experience that may affect future screening practices.

Decisions to undergo future CIN treatment were most influenced by the pain and cramping and the hydrorrhea of cryosurgery. It is unknown whether or when women will return for yearly preventive screening after experiencing cryosurgery. Winkler²³ reported that women who underwent bilateral tubal ligations who later developed cervical cancer had more than a 6-year time lapse before returning for cervical cancer screening, longer than the 4 years for those women without tubal ligations. Future work will explore the influence of the cryosurgical experience on compliance with future screenings and will include formal disutility measurements due to cryosurgical treatment.

Acknowledgments

Our work was supported in part by the Robert Wood Johnson Foundation (D.M.H).

Family physicians favor cryosurgery as a treatment method for cervical intraepithelial neoplasia (CIN), in part because it is inexpensive and requires the least technical training and skill. For treatment of ectocervical intraepithelial neoplasia that requires no histologic specimen, cryosurgery has been shown to produce tissue destruction between 8 and 12 mm deep, the depth needed to destroy potentially dysplastic deep gland clefts.^1,2 The healing process after cryosurgery is associated with a malodorous hydrorrhea (watery discharge),^3,4 in addition to pain and cramping. Obese and multigravid women are more bothered by a higher frequency of pad changes required for the hydrorrhea from cryosurgery,⁴ which suggests that these subpopulations may be at greater risk for increased malodorous hydrorrhea and other side effects from the procedure. Debridement of the cervical eschar after cryosurgery has been promoted as an anecdotal method for reducing the amount of malodorous hydrorrhea.⁵ By eliminating an exudate that breeds aerobic and anaerobic infection, a more rapid re-epithelialization may occur, and the malodor may be reduced.⁶ Despite these findings and although cervical cryosurgery has been used for more than 30 years, the natural history of the postprocedure process has never been quantitatively described.

The primary purpose of our study was to describe the natural history of the healing process after cervical cryosurgery. Six symptoms commonly experienced by women undergoing cryosurgery were used as markers of this process: the amount and duration of hydrorrhea, the number of pads used, the duration and intensity of the malodor associated with the hydrorrhea, and the duration of pain and cramping experienced. A second purpose was to determine the effect of mechanical debridement of the cervical eschar on these symptoms and to determine whether obesity and gravidity affected the 6 symptoms of healing. A greater understanding of the symptoms surrounding the postcryosurgery period may be beneficial during the procedure consent process, in addition to being used in cost-effectiveness analyses comparing cryosurgery with other treatment methods.

Methods

Study Population

We conducted a multicenter prospective randomized clinical trial from February 1995 through May 1996 at 4 diverse clinic sites: the gynecologic teaching clinics of Truman Medical Center-East at the University of Missouri-Kansas City and the family medicine clinics at the Medical College of Georgia, Louisiana State University, and the University of Kansas Medical Center. All women with a histologically documented CIN lesion that met the criteria for cryosurgery were recruited to participate at each clinic site. Inclusion criteria were that: (1) the woman was willing to participate; (2) the lesion extended less than 4 mm into the endocervical canal; (3) the surface extent of the cervical lesion occupied 2 quadrants or less; (4) the endocervical curettage, if necessary, was negative; (5) the colposcopic examination was satisfactory; and (6) there was no colposcopic, cytologic, or histologic evidence of cervical cancer. Exclusion criteria included any previous ablative or excisional cervical treatments, current vaginal infections as diagnosed by routine clinic procedure before cryosurgery, chronic hydrorrhea, cervical cancer, cryoglobulinemia, and pregnancy. The study protocol and consent form were approved by the local institutional review boards before the study. Pretrial work established that evaporative losses from pads were minimal.

Study Protocol

Of the 121 women invited to participate in the study, 90 agreed to be enrolled (74% participation rate). Forty-six women were randomized by even or odd medical record number to the debridement group before the cryosurgery and 38 to the nondebridement group. Six women who did not complete pad collection were dropped from the study. There was no significant difference between the debridement and nondebridement groups in demographic or gynecologic characteristics, indicating that randomization worked even though the group sizes were unequal [Table 1].

Medical record numbers were assigned at least 6 months before the procedure in a manner consistent with routine assignment at each clinic. Most women were pretreated with a nonsteroidal anti-inflammatory drug (NSAID) at least 30 minutes before the procedure and a cervical mucosal block immediately before the procedure. A 25-mm shallow nippled probe was used in the majority of the procedures. Women randomized to the debridement group returned between 48 and 60 hours after their cryosurgical procedure for mechanical debridement. A ringed forceps was used to gently peel back the cervical eschar from the most distal ectocervix toward the os in a radial manner.

All women were given a large selection of preweighed sanitary pads that were numbered and labeled in individual zip-lock bags for the duration of hydrorrhea or until menses started. Both groups were instructed to use the preweighed pads immediately after the cryosurgery procedure. To avoid frictional and evaporative losses, women were asked to use a minimum of 3 pads per 24-hour period, if continuous protection was needed. Each woman kept a diary of the numbered pads that were used each day she experienced hydrorrhea and noted the presence of an odor, pain or cramping, or menses. All pads were returned when the hydrorrhea ceased or menses started, and the pads were reweighed to determine the hydrorrhea amount. The patient was asked to keep the used pads at room temperature away from heat and cold sources during the collection process. At pad return, all women were asked to self-report whether they experienced any odor and if so, what the maximum intensity of malodor was on a 5-point Likert scale (1=no odor; 3=moderately smelly; 5=very smelly).

Statistical Analysis

We defined obesity as greater than 25 kg/m². The continuous demographic descriptors (age, height, weight, body mass index [BMI], gravidity, parity, and days from last menstrual period), the amount and duration of hydrorrhea, the duration and intensity of malodorous hydrorrhea, and the duration of the pain or cramping were compared using the Mann-Whitney U test. The categorical descriptors of race and histology were compared with chi-square testing. The comparisons of the healing symptoms between the cohorts whose hydrorrhea did and did not stop before menses and obese versus nonobese women were made with t tests for independent and dependent samples. Linear regression was used to determine whether BMI or gravidity predicted the 6 measures of the healing process. A 2-tailed a of 0.05 was considered significant. All statistics were computed with Statistica software (StatSoft, Tulsa, Okla).

There is an 80% power in our study to detect a difference of 120 g of total hydrorrhea between the debrided and nondebrided cohorts, a 50% power to detect a 5-day difference in the duration of the hydrorrhea, a 71% power to detect a 3-day difference in the duration of malodorous hydrorrhea, a 98% power to detect a 1.0-unit difference in Likert scale measurement of intensity of malodorous hydrorrhea, and a 75% power to detect a 2-day difference in the duration of pain or cramping after cryosurgery.

Results

The natural history of the healing process after cryosurgery was measured by the following proxies: the amount and duration of hydrorrhea, the number of pads used, the duration and intensity of malodor, and the level of pain or cramping. [Figure 1] depicts the pad usage and amount of hydrorrhea that was recorded after cryosurgery. The average total amount of hydrorrhea was 288 g (standard deviation [SD]=194), and the average daily amount of hydrorrhea was 24.9 g (SD=15.8). The average daily amount of hydrorrhea peaked on the second day after cryosurgery at 32.8 g (SD=20.2). The maximum daily hydrorrhea was 133 g on day 7 after cryosurgery, and the maximum total hydrorrhea experienced was 890 g. Women used, on average, a total of 41.3 pads of all sizes (SD=19.4) up to a maximum of 96 pads of all sizes for the hydrorrhea, changing pads a maximum of 10 times on day 11 after cryosurgery. The average number of pads used daily was 3.5 (SD=1.2).

The maximum duration of hydrorrhea was 29 days. None of the 20% of the study population who had menstrual cycles longer than 30 days, were using long-acting contraception, or were menopausal reported hydrorrhea for longer than 29 days. The average duration of hydrorrhea was 12.4 days (SD=5.5), and more than half of the total amount was discharged during the first 6 days after cryosurgery (mean=164.4 g; SD=91.4) versus 123.4 g (SD=133.4; P=.0024).

Women recorded malodor an average of 72.3% (SD=35.2%) of the time that they also experienced hydrorrhea, and the average duration of malodorous hydrorrhea was 8.9 days (SD=5.7) with a maximum of 23 days ([Figure 2]). Malodor was experienced by the greatest number of women on days 3 through 5 following cryosurgery, with 82.7% of women experiencing this on day 4 after cryosurgery. The intensity of the overall malodorous hydrorrhea was 3.4 (SD=1.2).

Women experienced pain and cramping following cryosurgery an average of 4.7 days (SD=3.5) with some reporting pain at 18 days. Pain and cramping were recorded 43.1% (SD=32.6%) of the days that there was also hydrorrhea; however, the duration of the pain and cramping was independent of the duration of the hydrorrhea.

Nearly one third of the study population (30.6%) ceased having hydrorrhea before their menses, which provided a subgroup to most accurately examine the postcryosurgery natural history. These women experienced an average total hydrorrhea amount of 365 g (SD=234), with an average daily hydrorrhea amount of 26.6 g (SD=15.7) and a discharge maximum of 803 g. This subset used an average of 46.0 pads (SD=21.1), changing pads a maximum of 10 times a day on day 11 after cryosurgery, and their average duration of hydrorrhea was 14.6 days (SD=5.8) with a maximum of 24 days of hydrorrhea. The total average amount of hydrorrhea and the average duration were significantly prolonged in this cohort of women compared with those whose pad collection stopped because of menses (average total of 365 g [SD=234] vs 261 g [SD=164], P=.0216; average duration of 14.6 days [SD=5.8] vs 11.5 days [SD 5.1], P=.0174).

Women whose hydrorrhea stopped before menses experienced more hydrorrhea during the first 7 days after cryosurgery than in the subsequent 17 days (217.5 g [SD=128.8] vs 147.3 g [SD=142.0], P=.0150). Because malodor is associated with the healing process, and the duration of pain or cramping after cryosurgery occurred most often in the early days of the healing process, these symptoms (malodor, pain and cramping) did not differ by reason for cessation of pad collection. The average duration of malodor for these women was 9.7 days (SD=6.9). In this group, 62.9% (SD=38.9%) acknowledged hydrorrhea associated with malodor, and 89.5% stated that this occurred on day 9 after cryosurgery. The mean intensity of the overall malodor was 3.2 (SD=1.1) on the 5-point Likert scale, more than moderately smelly. The average duration of the pain and cramping was 5.1 days (SD=4.4) which was present 41.5% (SD=36.6%) of the days that hydrorrhea was present.

There was no significant difference in the markers that we used to measure the healing process between the debrided and nondebrided cohorts [Table 2]. Debridement did not significantly reduce the amount of hydrorrhea, the number of pads used, the duration of hydrorrhea, the duration or the proportion of days with malodorous hydrorrhea, or the duration of pain or cramping that women experienced. In addition, these findings were consistent when we examined the subset of women whose hydrorrhea stopped before menses. One marker, however, the intensity of the malodorous hydrorrhea, was significantly less for women with eschar debridement than for those without debridement (3.1 [SD=1.1] vs 3.8 [SD=1.1], P=.0220).

We examined the influence of gravidity and obesity on the postcryosurgery course. Although gravidity was not predictive of our measures of the healing process, obesity as measured by a BMI greater than 25 kg/m² positively predicted the total amount of hydrorrhea (P=.0068). BMI was not, however, predictive of the daily amount of hydrorrhea, the number of pads needed, the duration of hydrorrhea, duration or intensity of malodor, and duration of pain and cramping. We examined the subset of obese women who completed their hydrorrhea before their menses (45.7% of the population had a BMI greater than 25 kg/², and 47.8% of these obese women completed their hydrorrhea before their menses). These women tended to have more hydrorrhea than the nonobese women in our study, (448 g [SD=247] vs 301 g [SD=182], P=.12). The average total number and the average daily number of pads used was significantly greater for obese women than nonobese women (63.3 [SD=19.0] vs 35.5 [SD=11.8], P=.0004, and 4.3 [SD=7.2] vs 2.9 [SD=0.5], P=.0450, respectively).

Obese women expelled more than half of their hydrorrhea within the first 8 days after cryosurgery when compared with the remaining time of hydrorrhea (218 g [SD=129] vs 147 g [SD=142], P=.0150). The most malodorous time of hydrorrhea was day 9 after cryosurgery, when 89.5% of obese women experienced malodor. Although both obese and nonobese women had hydrorrhea for the same total number of days, the time to expel half of the total hydrorrhea and the peak time of malodor lasted 2 to 5 days longer for obese women than for nonobese women (8 days to expel half of the hydrorrhea vs 6, peak malodor at 9 days vs 4, respectively). The average duration of pain or cramping for the obese women was 6.0 days (SD=5.6), occurring an average of 36.5% (SD=34.6%) of the days hydrorrhea was present, not statistically longer than for nonobese women.

Discussion

The natural history of the healing process after cryosurgery reveals a more prolonged, malodorous, and painful healing process than has been recognized by most clinicians. The women in our study who completed their hydrorrhea before the onset of their menses provide the clearest description of the natural history of cryosurgical healing independent of the potential confounder of the menstrual cycle. Our findings provide physicians with additional information to set appropriate expectations for cryosurgical healing and the post-treatment process at the time of consent. These findings are significant because women with an average body habitus and their treating physicians can expect the following: (1) an average of approximately 365 g (1.6 cups) of hydrorrhea postoperatively; (2) an average of 46 pads used for protection; (3) 7 days of heavy hydrorrhea out of the 2 to 4 weeks of expected hydrorrhea; (4) an average of 9 days of bad odor with the worst experienced on days 3 through 5; (5) noticeably bad odor for all women; and (6) pain and cramping following cryosurgery lasting an average of 5 days. Obese women have a more prolonged course of healing. The expectations for obese women are an average of approximately 450 g (2 cups) of hydrorrhea, an average of 65 pads used for protection, 8 days of heavy hydrorrhea, and the worst malodor on days 5 to 11 after cryosurgery.

Menses provide a useful gauge to compare the cryosurgical post-treatment and healing process. Menstrual hydrorrhea is composed of both blood and endometrial exudate,^7-9 while cryosurgical hydrorrhea is purely cervical exudate. The average menstrual hydrorrhea is reported between 35 and 60 mL per cycle,^10-13 while we found that the average total cryosurgical hydrorrhea may be up to 10 times that amount and can be an entire “menses-worth” in 1 day. Maximally, a woman can experience up to 30 times her menstrual volume in the month following cryosurgery. Ninety-two percent of the blood loss occurring during menses has occurred by the third day,¹⁴ while we showed that 90% of the total hydrorrhea has occurred by the 20th day. The severity of dysmenorrhea is correlated to the duration of menses.¹⁵ Women experience dysmenorrhea approximately 50% of the duration of their bleeding, 2 out of the 4 days;¹⁶ similarly, we have shown that women experience postcryosurgical pain and cramping approximately 42% of the time they have hydrorrhea.

Our study suggests that debridement after cryosurgery offers no advantages in comparison with the natural healing process. It does not decrease the amount or duration of hydrorrhea, the duration of malodorous hydrorrhea, or the duration of pain or cramping after the procedure. Debridement may reduce the overall intensity of malodor, but this small benefit must be weighed against the time and cost it takes an office to have women routinely return for debridement. In addition, only a fifth of the women who underwent debridement indicated they would return for future debridement, indicating low patient acceptance of this procedure even with its small benefit of diminishing the malodor. Nahhas and colleagues¹⁷ evaluated mechanical debridement of the cervical eschar 72 hours after cryosurgery, using the duration of hydrorrhea as a surrogate measure for the amount of hydrorrhea. Although inadequate power prevented significant conclusions about the effect of debridement on the duration of hydrorrhea in his study, he could not show any diminished hydrorrhea with debridement. Other reports of the effect of cervical debridement are anecdotal.⁵

Many postoperative complications and wound healing impairments are more common in obese than nonobese people.^18,19 This is the first report that obese women have a greater amount of hydrorrhea after cryosurgery and use significantly more pads but produce the hydrorrhea in the same number of days as nonobese women. This corroborates the finding that obese women are more bothered by pad changes than nonobese women.⁴ One reason obese women do not experience any more pain or cramping after cryosurgery than nonobese women is that they self-medicate more often than nonobese women,⁴ a medication pattern also seen by obese women for dysmenorrhea.¹⁶

The reduced quality of life that women experience after cryosurgery may potentially influence the cost-effectiveness of the procedure. Many interventions have been tested to decrease the symptoms of the healing process and to improve the tolerability of this post-treatment experience. To decrease the amount of hydrorrhea, some have tried a sugar solution applied to the vagina to alter the vaginal flora, thus promoting faster re-epithelialization and decreasing the hydrorrhea.²⁰ Others have tested the effect of systemic steroids for minimizing the immunologic reaction of inflammatory edema to the cervical tissue after the cryosurgical trauma.²¹ However, the risk of these nonstandard treatments outweighs the possible benefits of reduced hydrorrhea. Although there is scant literature on effective methods for decreasing the malodor of hydrorrhea, the pain and cramping that women experience after cryosurgery can be addressed directly by giving them permission to use NSAIDs or similar agents for the expected discomfort.

This work and its companion paper⁴ have described the symptoms women experience after cryosurgery and have advocated a better preprocedural informed consent process. We have also asked physicians to question their practice of treating women with CIN grade 1 human papillmavirus (CIN 1/HPV) lesions immediately with cryosurgery. Since CIN 1/HPV lesions regress to normal almost 80% of the time, the use of cryosurgery could be held for those recalcitrant lesions that do not regress, thus sparing women the experience of cryosurgery. These studies also provided the necessary data to explore how women experiencing the symptoms of healing after cryosurgery will comply with future cytology screenings. Future work will address this compliance.

Acknowledgments

This study was supported by the Wallach Surgical Devices, Orange, Conn (DGF) and by the Robert Wood Johnson Foundation (DMH).

We wish to thank all who helped with the pad distribution and weighing, especially Melissa Martinez-Fordham, who participated most fully in the process, exhibiting dedication, precision, and pleasant attitude throughout all pad weighing sessions, and Roberta O’Kelly and Rita Pruitt for their consistent clinical help.

Family physicians favor cryosurgery as a treatment method for cervical intraepithelial neoplasia (CIN), in part because it is inexpensive and requires the least technical training and skill. For treatment of ectocervical intraepithelial neoplasia that requires no histologic specimen, cryosurgery has been shown to produce tissue destruction between 8 and 12 mm deep, the depth needed to destroy potentially dysplastic deep gland clefts.^1,2 The healing process after cryosurgery is associated with a malodorous hydrorrhea (watery discharge),^3,4 in addition to pain and cramping. Obese and multigravid women are more bothered by a higher frequency of pad changes required for the hydrorrhea from cryosurgery,⁴ which suggests that these subpopulations may be at greater risk for increased malodorous hydrorrhea and other side effects from the procedure. Debridement of the cervical eschar after cryosurgery has been promoted as an anecdotal method for reducing the amount of malodorous hydrorrhea.⁵ By eliminating an exudate that breeds aerobic and anaerobic infection, a more rapid re-epithelialization may occur, and the malodor may be reduced.⁶ Despite these findings and although cervical cryosurgery has been used for more than 30 years, the natural history of the postprocedure process has never been quantitatively described.

The primary purpose of our study was to describe the natural history of the healing process after cervical cryosurgery. Six symptoms commonly experienced by women undergoing cryosurgery were used as markers of this process: the amount and duration of hydrorrhea, the number of pads used, the duration and intensity of the malodor associated with the hydrorrhea, and the duration of pain and cramping experienced. A second purpose was to determine the effect of mechanical debridement of the cervical eschar on these symptoms and to determine whether obesity and gravidity affected the 6 symptoms of healing. A greater understanding of the symptoms surrounding the postcryosurgery period may be beneficial during the procedure consent process, in addition to being used in cost-effectiveness analyses comparing cryosurgery with other treatment methods.

Methods

Study Population

We conducted a multicenter prospective randomized clinical trial from February 1995 through May 1996 at 4 diverse clinic sites: the gynecologic teaching clinics of Truman Medical Center-East at the University of Missouri-Kansas City and the family medicine clinics at the Medical College of Georgia, Louisiana State University, and the University of Kansas Medical Center. All women with a histologically documented CIN lesion that met the criteria for cryosurgery were recruited to participate at each clinic site. Inclusion criteria were that: (1) the woman was willing to participate; (2) the lesion extended less than 4 mm into the endocervical canal; (3) the surface extent of the cervical lesion occupied 2 quadrants or less; (4) the endocervical curettage, if necessary, was negative; (5) the colposcopic examination was satisfactory; and (6) there was no colposcopic, cytologic, or histologic evidence of cervical cancer. Exclusion criteria included any previous ablative or excisional cervical treatments, current vaginal infections as diagnosed by routine clinic procedure before cryosurgery, chronic hydrorrhea, cervical cancer, cryoglobulinemia, and pregnancy. The study protocol and consent form were approved by the local institutional review boards before the study. Pretrial work established that evaporative losses from pads were minimal.

Study Protocol

Of the 121 women invited to participate in the study, 90 agreed to be enrolled (74% participation rate). Forty-six women were randomized by even or odd medical record number to the debridement group before the cryosurgery and 38 to the nondebridement group. Six women who did not complete pad collection were dropped from the study. There was no significant difference between the debridement and nondebridement groups in demographic or gynecologic characteristics, indicating that randomization worked even though the group sizes were unequal [Table 1].

Medical record numbers were assigned at least 6 months before the procedure in a manner consistent with routine assignment at each clinic. Most women were pretreated with a nonsteroidal anti-inflammatory drug (NSAID) at least 30 minutes before the procedure and a cervical mucosal block immediately before the procedure. A 25-mm shallow nippled probe was used in the majority of the procedures. Women randomized to the debridement group returned between 48 and 60 hours after their cryosurgical procedure for mechanical debridement. A ringed forceps was used to gently peel back the cervical eschar from the most distal ectocervix toward the os in a radial manner.

All women were given a large selection of preweighed sanitary pads that were numbered and labeled in individual zip-lock bags for the duration of hydrorrhea or until menses started. Both groups were instructed to use the preweighed pads immediately after the cryosurgery procedure. To avoid frictional and evaporative losses, women were asked to use a minimum of 3 pads per 24-hour period, if continuous protection was needed. Each woman kept a diary of the numbered pads that were used each day she experienced hydrorrhea and noted the presence of an odor, pain or cramping, or menses. All pads were returned when the hydrorrhea ceased or menses started, and the pads were reweighed to determine the hydrorrhea amount. The patient was asked to keep the used pads at room temperature away from heat and cold sources during the collection process. At pad return, all women were asked to self-report whether they experienced any odor and if so, what the maximum intensity of malodor was on a 5-point Likert scale (1=no odor; 3=moderately smelly; 5=very smelly).

Statistical Analysis

We defined obesity as greater than 25 kg/m². The continuous demographic descriptors (age, height, weight, body mass index [BMI], gravidity, parity, and days from last menstrual period), the amount and duration of hydrorrhea, the duration and intensity of malodorous hydrorrhea, and the duration of the pain or cramping were compared using the Mann-Whitney U test. The categorical descriptors of race and histology were compared with chi-square testing. The comparisons of the healing symptoms between the cohorts whose hydrorrhea did and did not stop before menses and obese versus nonobese women were made with t tests for independent and dependent samples. Linear regression was used to determine whether BMI or gravidity predicted the 6 measures of the healing process. A 2-tailed a of 0.05 was considered significant. All statistics were computed with Statistica software (StatSoft, Tulsa, Okla).

There is an 80% power in our study to detect a difference of 120 g of total hydrorrhea between the debrided and nondebrided cohorts, a 50% power to detect a 5-day difference in the duration of the hydrorrhea, a 71% power to detect a 3-day difference in the duration of malodorous hydrorrhea, a 98% power to detect a 1.0-unit difference in Likert scale measurement of intensity of malodorous hydrorrhea, and a 75% power to detect a 2-day difference in the duration of pain or cramping after cryosurgery.

Results

The natural history of the healing process after cryosurgery was measured by the following proxies: the amount and duration of hydrorrhea, the number of pads used, the duration and intensity of malodor, and the level of pain or cramping. [Figure 1] depicts the pad usage and amount of hydrorrhea that was recorded after cryosurgery. The average total amount of hydrorrhea was 288 g (standard deviation [SD]=194), and the average daily amount of hydrorrhea was 24.9 g (SD=15.8). The average daily amount of hydrorrhea peaked on the second day after cryosurgery at 32.8 g (SD=20.2). The maximum daily hydrorrhea was 133 g on day 7 after cryosurgery, and the maximum total hydrorrhea experienced was 890 g. Women used, on average, a total of 41.3 pads of all sizes (SD=19.4) up to a maximum of 96 pads of all sizes for the hydrorrhea, changing pads a maximum of 10 times on day 11 after cryosurgery. The average number of pads used daily was 3.5 (SD=1.2).

The maximum duration of hydrorrhea was 29 days. None of the 20% of the study population who had menstrual cycles longer than 30 days, were using long-acting contraception, or were menopausal reported hydrorrhea for longer than 29 days. The average duration of hydrorrhea was 12.4 days (SD=5.5), and more than half of the total amount was discharged during the first 6 days after cryosurgery (mean=164.4 g; SD=91.4) versus 123.4 g (SD=133.4; P=.0024).

Women recorded malodor an average of 72.3% (SD=35.2%) of the time that they also experienced hydrorrhea, and the average duration of malodorous hydrorrhea was 8.9 days (SD=5.7) with a maximum of 23 days ([Figure 2]). Malodor was experienced by the greatest number of women on days 3 through 5 following cryosurgery, with 82.7% of women experiencing this on day 4 after cryosurgery. The intensity of the overall malodorous hydrorrhea was 3.4 (SD=1.2).

Women experienced pain and cramping following cryosurgery an average of 4.7 days (SD=3.5) with some reporting pain at 18 days. Pain and cramping were recorded 43.1% (SD=32.6%) of the days that there was also hydrorrhea; however, the duration of the pain and cramping was independent of the duration of the hydrorrhea.

Nearly one third of the study population (30.6%) ceased having hydrorrhea before their menses, which provided a subgroup to most accurately examine the postcryosurgery natural history. These women experienced an average total hydrorrhea amount of 365 g (SD=234), with an average daily hydrorrhea amount of 26.6 g (SD=15.7) and a discharge maximum of 803 g. This subset used an average of 46.0 pads (SD=21.1), changing pads a maximum of 10 times a day on day 11 after cryosurgery, and their average duration of hydrorrhea was 14.6 days (SD=5.8) with a maximum of 24 days of hydrorrhea. The total average amount of hydrorrhea and the average duration were significantly prolonged in this cohort of women compared with those whose pad collection stopped because of menses (average total of 365 g [SD=234] vs 261 g [SD=164], P=.0216; average duration of 14.6 days [SD=5.8] vs 11.5 days [SD 5.1], P=.0174).

Women whose hydrorrhea stopped before menses experienced more hydrorrhea during the first 7 days after cryosurgery than in the subsequent 17 days (217.5 g [SD=128.8] vs 147.3 g [SD=142.0], P=.0150). Because malodor is associated with the healing process, and the duration of pain or cramping after cryosurgery occurred most often in the early days of the healing process, these symptoms (malodor, pain and cramping) did not differ by reason for cessation of pad collection. The average duration of malodor for these women was 9.7 days (SD=6.9). In this group, 62.9% (SD=38.9%) acknowledged hydrorrhea associated with malodor, and 89.5% stated that this occurred on day 9 after cryosurgery. The mean intensity of the overall malodor was 3.2 (SD=1.1) on the 5-point Likert scale, more than moderately smelly. The average duration of the pain and cramping was 5.1 days (SD=4.4) which was present 41.5% (SD=36.6%) of the days that hydrorrhea was present.

There was no significant difference in the markers that we used to measure the healing process between the debrided and nondebrided cohorts [Table 2]. Debridement did not significantly reduce the amount of hydrorrhea, the number of pads used, the duration of hydrorrhea, the duration or the proportion of days with malodorous hydrorrhea, or the duration of pain or cramping that women experienced. In addition, these findings were consistent when we examined the subset of women whose hydrorrhea stopped before menses. One marker, however, the intensity of the malodorous hydrorrhea, was significantly less for women with eschar debridement than for those without debridement (3.1 [SD=1.1] vs 3.8 [SD=1.1], P=.0220).

We examined the influence of gravidity and obesity on the postcryosurgery course. Although gravidity was not predictive of our measures of the healing process, obesity as measured by a BMI greater than 25 kg/m² positively predicted the total amount of hydrorrhea (P=.0068). BMI was not, however, predictive of the daily amount of hydrorrhea, the number of pads needed, the duration of hydrorrhea, duration or intensity of malodor, and duration of pain and cramping. We examined the subset of obese women who completed their hydrorrhea before their menses (45.7% of the population had a BMI greater than 25 kg/², and 47.8% of these obese women completed their hydrorrhea before their menses). These women tended to have more hydrorrhea than the nonobese women in our study, (448 g [SD=247] vs 301 g [SD=182], P=.12). The average total number and the average daily number of pads used was significantly greater for obese women than nonobese women (63.3 [SD=19.0] vs 35.5 [SD=11.8], P=.0004, and 4.3 [SD=7.2] vs 2.9 [SD=0.5], P=.0450, respectively).

Obese women expelled more than half of their hydrorrhea within the first 8 days after cryosurgery when compared with the remaining time of hydrorrhea (218 g [SD=129] vs 147 g [SD=142], P=.0150). The most malodorous time of hydrorrhea was day 9 after cryosurgery, when 89.5% of obese women experienced malodor. Although both obese and nonobese women had hydrorrhea for the same total number of days, the time to expel half of the total hydrorrhea and the peak time of malodor lasted 2 to 5 days longer for obese women than for nonobese women (8 days to expel half of the hydrorrhea vs 6, peak malodor at 9 days vs 4, respectively). The average duration of pain or cramping for the obese women was 6.0 days (SD=5.6), occurring an average of 36.5% (SD=34.6%) of the days hydrorrhea was present, not statistically longer than for nonobese women.

Discussion

The natural history of the healing process after cryosurgery reveals a more prolonged, malodorous, and painful healing process than has been recognized by most clinicians. The women in our study who completed their hydrorrhea before the onset of their menses provide the clearest description of the natural history of cryosurgical healing independent of the potential confounder of the menstrual cycle. Our findings provide physicians with additional information to set appropriate expectations for cryosurgical healing and the post-treatment process at the time of consent. These findings are significant because women with an average body habitus and their treating physicians can expect the following: (1) an average of approximately 365 g (1.6 cups) of hydrorrhea postoperatively; (2) an average of 46 pads used for protection; (3) 7 days of heavy hydrorrhea out of the 2 to 4 weeks of expected hydrorrhea; (4) an average of 9 days of bad odor with the worst experienced on days 3 through 5; (5) noticeably bad odor for all women; and (6) pain and cramping following cryosurgery lasting an average of 5 days. Obese women have a more prolonged course of healing. The expectations for obese women are an average of approximately 450 g (2 cups) of hydrorrhea, an average of 65 pads used for protection, 8 days of heavy hydrorrhea, and the worst malodor on days 5 to 11 after cryosurgery.

Menses provide a useful gauge to compare the cryosurgical post-treatment and healing process. Menstrual hydrorrhea is composed of both blood and endometrial exudate,^7-9 while cryosurgical hydrorrhea is purely cervical exudate. The average menstrual hydrorrhea is reported between 35 and 60 mL per cycle,^10-13 while we found that the average total cryosurgical hydrorrhea may be up to 10 times that amount and can be an entire “menses-worth” in 1 day. Maximally, a woman can experience up to 30 times her menstrual volume in the month following cryosurgery. Ninety-two percent of the blood loss occurring during menses has occurred by the third day,¹⁴ while we showed that 90% of the total hydrorrhea has occurred by the 20th day. The severity of dysmenorrhea is correlated to the duration of menses.¹⁵ Women experience dysmenorrhea approximately 50% of the duration of their bleeding, 2 out of the 4 days;¹⁶ similarly, we have shown that women experience postcryosurgical pain and cramping approximately 42% of the time they have hydrorrhea.

Our study suggests that debridement after cryosurgery offers no advantages in comparison with the natural healing process. It does not decrease the amount or duration of hydrorrhea, the duration of malodorous hydrorrhea, or the duration of pain or cramping after the procedure. Debridement may reduce the overall intensity of malodor, but this small benefit must be weighed against the time and cost it takes an office to have women routinely return for debridement. In addition, only a fifth of the women who underwent debridement indicated they would return for future debridement, indicating low patient acceptance of this procedure even with its small benefit of diminishing the malodor. Nahhas and colleagues¹⁷ evaluated mechanical debridement of the cervical eschar 72 hours after cryosurgery, using the duration of hydrorrhea as a surrogate measure for the amount of hydrorrhea. Although inadequate power prevented significant conclusions about the effect of debridement on the duration of hydrorrhea in his study, he could not show any diminished hydrorrhea with debridement. Other reports of the effect of cervical debridement are anecdotal.⁵

Many postoperative complications and wound healing impairments are more common in obese than nonobese people.^18,19 This is the first report that obese women have a greater amount of hydrorrhea after cryosurgery and use significantly more pads but produce the hydrorrhea in the same number of days as nonobese women. This corroborates the finding that obese women are more bothered by pad changes than nonobese women.⁴ One reason obese women do not experience any more pain or cramping after cryosurgery than nonobese women is that they self-medicate more often than nonobese women,⁴ a medication pattern also seen by obese women for dysmenorrhea.¹⁶

The reduced quality of life that women experience after cryosurgery may potentially influence the cost-effectiveness of the procedure. Many interventions have been tested to decrease the symptoms of the healing process and to improve the tolerability of this post-treatment experience. To decrease the amount of hydrorrhea, some have tried a sugar solution applied to the vagina to alter the vaginal flora, thus promoting faster re-epithelialization and decreasing the hydrorrhea.²⁰ Others have tested the effect of systemic steroids for minimizing the immunologic reaction of inflammatory edema to the cervical tissue after the cryosurgical trauma.²¹ However, the risk of these nonstandard treatments outweighs the possible benefits of reduced hydrorrhea. Although there is scant literature on effective methods for decreasing the malodor of hydrorrhea, the pain and cramping that women experience after cryosurgery can be addressed directly by giving them permission to use NSAIDs or similar agents for the expected discomfort.

This work and its companion paper⁴ have described the symptoms women experience after cryosurgery and have advocated a better preprocedural informed consent process. We have also asked physicians to question their practice of treating women with CIN grade 1 human papillmavirus (CIN 1/HPV) lesions immediately with cryosurgery. Since CIN 1/HPV lesions regress to normal almost 80% of the time, the use of cryosurgery could be held for those recalcitrant lesions that do not regress, thus sparing women the experience of cryosurgery. These studies also provided the necessary data to explore how women experiencing the symptoms of healing after cryosurgery will comply with future cytology screenings. Future work will address this compliance.

Acknowledgments

This study was supported by the Wallach Surgical Devices, Orange, Conn (DGF) and by the Robert Wood Johnson Foundation (DMH).

We wish to thank all who helped with the pad distribution and weighing, especially Melissa Martinez-Fordham, who participated most fully in the process, exhibiting dedication, precision, and pleasant attitude throughout all pad weighing sessions, and Roberta O’Kelly and Rita Pruitt for their consistent clinical help.

Family physicians favor cryosurgery as a treatment method for cervical intraepithelial neoplasia (CIN), in part because it is inexpensive and requires the least technical training and skill. For treatment of ectocervical intraepithelial neoplasia that requires no histologic specimen, cryosurgery has been shown to produce tissue destruction between 8 and 12 mm deep, the depth needed to destroy potentially dysplastic deep gland clefts.^1,2 The healing process after cryosurgery is associated with a malodorous hydrorrhea (watery discharge),^3,4 in addition to pain and cramping. Obese and multigravid women are more bothered by a higher frequency of pad changes required for the hydrorrhea from cryosurgery,⁴ which suggests that these subpopulations may be at greater risk for increased malodorous hydrorrhea and other side effects from the procedure. Debridement of the cervical eschar after cryosurgery has been promoted as an anecdotal method for reducing the amount of malodorous hydrorrhea.⁵ By eliminating an exudate that breeds aerobic and anaerobic infection, a more rapid re-epithelialization may occur, and the malodor may be reduced.⁶ Despite these findings and although cervical cryosurgery has been used for more than 30 years, the natural history of the postprocedure process has never been quantitatively described.

The primary purpose of our study was to describe the natural history of the healing process after cervical cryosurgery. Six symptoms commonly experienced by women undergoing cryosurgery were used as markers of this process: the amount and duration of hydrorrhea, the number of pads used, the duration and intensity of the malodor associated with the hydrorrhea, and the duration of pain and cramping experienced. A second purpose was to determine the effect of mechanical debridement of the cervical eschar on these symptoms and to determine whether obesity and gravidity affected the 6 symptoms of healing. A greater understanding of the symptoms surrounding the postcryosurgery period may be beneficial during the procedure consent process, in addition to being used in cost-effectiveness analyses comparing cryosurgery with other treatment methods.

Methods

Study Population

We conducted a multicenter prospective randomized clinical trial from February 1995 through May 1996 at 4 diverse clinic sites: the gynecologic teaching clinics of Truman Medical Center-East at the University of Missouri-Kansas City and the family medicine clinics at the Medical College of Georgia, Louisiana State University, and the University of Kansas Medical Center. All women with a histologically documented CIN lesion that met the criteria for cryosurgery were recruited to participate at each clinic site. Inclusion criteria were that: (1) the woman was willing to participate; (2) the lesion extended less than 4 mm into the endocervical canal; (3) the surface extent of the cervical lesion occupied 2 quadrants or less; (4) the endocervical curettage, if necessary, was negative; (5) the colposcopic examination was satisfactory; and (6) there was no colposcopic, cytologic, or histologic evidence of cervical cancer. Exclusion criteria included any previous ablative or excisional cervical treatments, current vaginal infections as diagnosed by routine clinic procedure before cryosurgery, chronic hydrorrhea, cervical cancer, cryoglobulinemia, and pregnancy. The study protocol and consent form were approved by the local institutional review boards before the study. Pretrial work established that evaporative losses from pads were minimal.

Study Protocol

Of the 121 women invited to participate in the study, 90 agreed to be enrolled (74% participation rate). Forty-six women were randomized by even or odd medical record number to the debridement group before the cryosurgery and 38 to the nondebridement group. Six women who did not complete pad collection were dropped from the study. There was no significant difference between the debridement and nondebridement groups in demographic or gynecologic characteristics, indicating that randomization worked even though the group sizes were unequal [Table 1].

Medical record numbers were assigned at least 6 months before the procedure in a manner consistent with routine assignment at each clinic. Most women were pretreated with a nonsteroidal anti-inflammatory drug (NSAID) at least 30 minutes before the procedure and a cervical mucosal block immediately before the procedure. A 25-mm shallow nippled probe was used in the majority of the procedures. Women randomized to the debridement group returned between 48 and 60 hours after their cryosurgical procedure for mechanical debridement. A ringed forceps was used to gently peel back the cervical eschar from the most distal ectocervix toward the os in a radial manner.

All women were given a large selection of preweighed sanitary pads that were numbered and labeled in individual zip-lock bags for the duration of hydrorrhea or until menses started. Both groups were instructed to use the preweighed pads immediately after the cryosurgery procedure. To avoid frictional and evaporative losses, women were asked to use a minimum of 3 pads per 24-hour period, if continuous protection was needed. Each woman kept a diary of the numbered pads that were used each day she experienced hydrorrhea and noted the presence of an odor, pain or cramping, or menses. All pads were returned when the hydrorrhea ceased or menses started, and the pads were reweighed to determine the hydrorrhea amount. The patient was asked to keep the used pads at room temperature away from heat and cold sources during the collection process. At pad return, all women were asked to self-report whether they experienced any odor and if so, what the maximum intensity of malodor was on a 5-point Likert scale (1=no odor; 3=moderately smelly; 5=very smelly).

Statistical Analysis

We defined obesity as greater than 25 kg/m². The continuous demographic descriptors (age, height, weight, body mass index [BMI], gravidity, parity, and days from last menstrual period), the amount and duration of hydrorrhea, the duration and intensity of malodorous hydrorrhea, and the duration of the pain or cramping were compared using the Mann-Whitney U test. The categorical descriptors of race and histology were compared with chi-square testing. The comparisons of the healing symptoms between the cohorts whose hydrorrhea did and did not stop before menses and obese versus nonobese women were made with t tests for independent and dependent samples. Linear regression was used to determine whether BMI or gravidity predicted the 6 measures of the healing process. A 2-tailed a of 0.05 was considered significant. All statistics were computed with Statistica software (StatSoft, Tulsa, Okla).

There is an 80% power in our study to detect a difference of 120 g of total hydrorrhea between the debrided and nondebrided cohorts, a 50% power to detect a 5-day difference in the duration of the hydrorrhea, a 71% power to detect a 3-day difference in the duration of malodorous hydrorrhea, a 98% power to detect a 1.0-unit difference in Likert scale measurement of intensity of malodorous hydrorrhea, and a 75% power to detect a 2-day difference in the duration of pain or cramping after cryosurgery.

Results

The natural history of the healing process after cryosurgery was measured by the following proxies: the amount and duration of hydrorrhea, the number of pads used, the duration and intensity of malodor, and the level of pain or cramping. [Figure 1] depicts the pad usage and amount of hydrorrhea that was recorded after cryosurgery. The average total amount of hydrorrhea was 288 g (standard deviation [SD]=194), and the average daily amount of hydrorrhea was 24.9 g (SD=15.8). The average daily amount of hydrorrhea peaked on the second day after cryosurgery at 32.8 g (SD=20.2). The maximum daily hydrorrhea was 133 g on day 7 after cryosurgery, and the maximum total hydrorrhea experienced was 890 g. Women used, on average, a total of 41.3 pads of all sizes (SD=19.4) up to a maximum of 96 pads of all sizes for the hydrorrhea, changing pads a maximum of 10 times on day 11 after cryosurgery. The average number of pads used daily was 3.5 (SD=1.2).

The maximum duration of hydrorrhea was 29 days. None of the 20% of the study population who had menstrual cycles longer than 30 days, were using long-acting contraception, or were menopausal reported hydrorrhea for longer than 29 days. The average duration of hydrorrhea was 12.4 days (SD=5.5), and more than half of the total amount was discharged during the first 6 days after cryosurgery (mean=164.4 g; SD=91.4) versus 123.4 g (SD=133.4; P=.0024).

Women recorded malodor an average of 72.3% (SD=35.2%) of the time that they also experienced hydrorrhea, and the average duration of malodorous hydrorrhea was 8.9 days (SD=5.7) with a maximum of 23 days ([Figure 2]). Malodor was experienced by the greatest number of women on days 3 through 5 following cryosurgery, with 82.7% of women experiencing this on day 4 after cryosurgery. The intensity of the overall malodorous hydrorrhea was 3.4 (SD=1.2).

Women experienced pain and cramping following cryosurgery an average of 4.7 days (SD=3.5) with some reporting pain at 18 days. Pain and cramping were recorded 43.1% (SD=32.6%) of the days that there was also hydrorrhea; however, the duration of the pain and cramping was independent of the duration of the hydrorrhea.

Nearly one third of the study population (30.6%) ceased having hydrorrhea before their menses, which provided a subgroup to most accurately examine the postcryosurgery natural history. These women experienced an average total hydrorrhea amount of 365 g (SD=234), with an average daily hydrorrhea amount of 26.6 g (SD=15.7) and a discharge maximum of 803 g. This subset used an average of 46.0 pads (SD=21.1), changing pads a maximum of 10 times a day on day 11 after cryosurgery, and their average duration of hydrorrhea was 14.6 days (SD=5.8) with a maximum of 24 days of hydrorrhea. The total average amount of hydrorrhea and the average duration were significantly prolonged in this cohort of women compared with those whose pad collection stopped because of menses (average total of 365 g [SD=234] vs 261 g [SD=164], P=.0216; average duration of 14.6 days [SD=5.8] vs 11.5 days [SD 5.1], P=.0174).

Women whose hydrorrhea stopped before menses experienced more hydrorrhea during the first 7 days after cryosurgery than in the subsequent 17 days (217.5 g [SD=128.8] vs 147.3 g [SD=142.0], P=.0150). Because malodor is associated with the healing process, and the duration of pain or cramping after cryosurgery occurred most often in the early days of the healing process, these symptoms (malodor, pain and cramping) did not differ by reason for cessation of pad collection. The average duration of malodor for these women was 9.7 days (SD=6.9). In this group, 62.9% (SD=38.9%) acknowledged hydrorrhea associated with malodor, and 89.5% stated that this occurred on day 9 after cryosurgery. The mean intensity of the overall malodor was 3.2 (SD=1.1) on the 5-point Likert scale, more than moderately smelly. The average duration of the pain and cramping was 5.1 days (SD=4.4) which was present 41.5% (SD=36.6%) of the days that hydrorrhea was present.

There was no significant difference in the markers that we used to measure the healing process between the debrided and nondebrided cohorts [Table 2]. Debridement did not significantly reduce the amount of hydrorrhea, the number of pads used, the duration of hydrorrhea, the duration or the proportion of days with malodorous hydrorrhea, or the duration of pain or cramping that women experienced. In addition, these findings were consistent when we examined the subset of women whose hydrorrhea stopped before menses. One marker, however, the intensity of the malodorous hydrorrhea, was significantly less for women with eschar debridement than for those without debridement (3.1 [SD=1.1] vs 3.8 [SD=1.1], P=.0220).

We examined the influence of gravidity and obesity on the postcryosurgery course. Although gravidity was not predictive of our measures of the healing process, obesity as measured by a BMI greater than 25 kg/m² positively predicted the total amount of hydrorrhea (P=.0068). BMI was not, however, predictive of the daily amount of hydrorrhea, the number of pads needed, the duration of hydrorrhea, duration or intensity of malodor, and duration of pain and cramping. We examined the subset of obese women who completed their hydrorrhea before their menses (45.7% of the population had a BMI greater than 25 kg/², and 47.8% of these obese women completed their hydrorrhea before their menses). These women tended to have more hydrorrhea than the nonobese women in our study, (448 g [SD=247] vs 301 g [SD=182], P=.12). The average total number and the average daily number of pads used was significantly greater for obese women than nonobese women (63.3 [SD=19.0] vs 35.5 [SD=11.8], P=.0004, and 4.3 [SD=7.2] vs 2.9 [SD=0.5], P=.0450, respectively).

Obese women expelled more than half of their hydrorrhea within the first 8 days after cryosurgery when compared with the remaining time of hydrorrhea (218 g [SD=129] vs 147 g [SD=142], P=.0150). The most malodorous time of hydrorrhea was day 9 after cryosurgery, when 89.5% of obese women experienced malodor. Although both obese and nonobese women had hydrorrhea for the same total number of days, the time to expel half of the total hydrorrhea and the peak time of malodor lasted 2 to 5 days longer for obese women than for nonobese women (8 days to expel half of the hydrorrhea vs 6, peak malodor at 9 days vs 4, respectively). The average duration of pain or cramping for the obese women was 6.0 days (SD=5.6), occurring an average of 36.5% (SD=34.6%) of the days hydrorrhea was present, not statistically longer than for nonobese women.

Discussion

The natural history of the healing process after cryosurgery reveals a more prolonged, malodorous, and painful healing process than has been recognized by most clinicians. The women in our study who completed their hydrorrhea before the onset of their menses provide the clearest description of the natural history of cryosurgical healing independent of the potential confounder of the menstrual cycle. Our findings provide physicians with additional information to set appropriate expectations for cryosurgical healing and the post-treatment process at the time of consent. These findings are significant because women with an average body habitus and their treating physicians can expect the following: (1) an average of approximately 365 g (1.6 cups) of hydrorrhea postoperatively; (2) an average of 46 pads used for protection; (3) 7 days of heavy hydrorrhea out of the 2 to 4 weeks of expected hydrorrhea; (4) an average of 9 days of bad odor with the worst experienced on days 3 through 5; (5) noticeably bad odor for all women; and (6) pain and cramping following cryosurgery lasting an average of 5 days. Obese women have a more prolonged course of healing. The expectations for obese women are an average of approximately 450 g (2 cups) of hydrorrhea, an average of 65 pads used for protection, 8 days of heavy hydrorrhea, and the worst malodor on days 5 to 11 after cryosurgery.

Menses provide a useful gauge to compare the cryosurgical post-treatment and healing process. Menstrual hydrorrhea is composed of both blood and endometrial exudate,^7-9 while cryosurgical hydrorrhea is purely cervical exudate. The average menstrual hydrorrhea is reported between 35 and 60 mL per cycle,^10-13 while we found that the average total cryosurgical hydrorrhea may be up to 10 times that amount and can be an entire “menses-worth” in 1 day. Maximally, a woman can experience up to 30 times her menstrual volume in the month following cryosurgery. Ninety-two percent of the blood loss occurring during menses has occurred by the third day,¹⁴ while we showed that 90% of the total hydrorrhea has occurred by the 20th day. The severity of dysmenorrhea is correlated to the duration of menses.¹⁵ Women experience dysmenorrhea approximately 50% of the duration of their bleeding, 2 out of the 4 days;¹⁶ similarly, we have shown that women experience postcryosurgical pain and cramping approximately 42% of the time they have hydrorrhea.

Our study suggests that debridement after cryosurgery offers no advantages in comparison with the natural healing process. It does not decrease the amount or duration of hydrorrhea, the duration of malodorous hydrorrhea, or the duration of pain or cramping after the procedure. Debridement may reduce the overall intensity of malodor, but this small benefit must be weighed against the time and cost it takes an office to have women routinely return for debridement. In addition, only a fifth of the women who underwent debridement indicated they would return for future debridement, indicating low patient acceptance of this procedure even with its small benefit of diminishing the malodor. Nahhas and colleagues¹⁷ evaluated mechanical debridement of the cervical eschar 72 hours after cryosurgery, using the duration of hydrorrhea as a surrogate measure for the amount of hydrorrhea. Although inadequate power prevented significant conclusions about the effect of debridement on the duration of hydrorrhea in his study, he could not show any diminished hydrorrhea with debridement. Other reports of the effect of cervical debridement are anecdotal.⁵

Many postoperative complications and wound healing impairments are more common in obese than nonobese people.^18,19 This is the first report that obese women have a greater amount of hydrorrhea after cryosurgery and use significantly more pads but produce the hydrorrhea in the same number of days as nonobese women. This corroborates the finding that obese women are more bothered by pad changes than nonobese women.⁴ One reason obese women do not experience any more pain or cramping after cryosurgery than nonobese women is that they self-medicate more often than nonobese women,⁴ a medication pattern also seen by obese women for dysmenorrhea.¹⁶

The reduced quality of life that women experience after cryosurgery may potentially influence the cost-effectiveness of the procedure. Many interventions have been tested to decrease the symptoms of the healing process and to improve the tolerability of this post-treatment experience. To decrease the amount of hydrorrhea, some have tried a sugar solution applied to the vagina to alter the vaginal flora, thus promoting faster re-epithelialization and decreasing the hydrorrhea.²⁰ Others have tested the effect of systemic steroids for minimizing the immunologic reaction of inflammatory edema to the cervical tissue after the cryosurgical trauma.²¹ However, the risk of these nonstandard treatments outweighs the possible benefits of reduced hydrorrhea. Although there is scant literature on effective methods for decreasing the malodor of hydrorrhea, the pain and cramping that women experience after cryosurgery can be addressed directly by giving them permission to use NSAIDs or similar agents for the expected discomfort.

This work and its companion paper⁴ have described the symptoms women experience after cryosurgery and have advocated a better preprocedural informed consent process. We have also asked physicians to question their practice of treating women with CIN grade 1 human papillmavirus (CIN 1/HPV) lesions immediately with cryosurgery. Since CIN 1/HPV lesions regress to normal almost 80% of the time, the use of cryosurgery could be held for those recalcitrant lesions that do not regress, thus sparing women the experience of cryosurgery. These studies also provided the necessary data to explore how women experiencing the symptoms of healing after cryosurgery will comply with future cytology screenings. Future work will address this compliance.

Acknowledgments

This study was supported by the Wallach Surgical Devices, Orange, Conn (DGF) and by the Robert Wood Johnson Foundation (DMH).

We wish to thank all who helped with the pad distribution and weighing, especially Melissa Martinez-Fordham, who participated most fully in the process, exhibiting dedication, precision, and pleasant attitude throughout all pad weighing sessions, and Roberta O’Kelly and Rita Pruitt for their consistent clinical help.

The goal of colposcopy is to identify women with high-grade disease through appropriately targeted biopsy and to correlate the cytologic-colposcopic-histologic results into a cohesive and appropriate management strategy. Approximately 80% of gynecologists and 10% of family physicians in New Hampshire currently provide access to colposcopy. These physicians have a desire to network to improve their colposcopic accuracy.¹ Little work has been published either to define adequate access to colposcopy for any population of women or to improve colposcopic accuracy. Active maintenance and improvement of colposcopic skills are important, because they deteriorate after initial training. Several studies have reported lower than 50% sensitivity for detecting the quadrant of the cervix where the cervical intraepithelial neoplasia (CIN) is present.^2-4 “See and treat” electrosurgical loop excision procedures have resulted in up to 50% of the specimens being histologically normal.^5-9 These high rates of inaccuracy happen because of colposcopists’ inability to distinguish normal from abnormal cervical tissue. Without a dedicated desire to maintain and improve their skills, colposcopists may inadvertently overtreat women on the pretext of preventing cervical cancer.

One potential method for improving colposcopic recognition skills is the development of a network of telecolposcopists who share patient histories, colposcopic images, and histology correlations on a routine basis. Before determining whether this network would improve colposcopic care, it must first be shown that telecolposcopic images can be transmitted to and recognized accurately at the reception site.

Radiologists, dermatologists, pathologists, and psychiatrists^10-13 have accurately relayed image transmissions. The fields of otorhinolaryngology, ophthalmology, cardiology, pulmonology, and emergency medicine have also reported telemedicine capabilities during the past few years. Teleobstetrics has demonstrated the feasibility of remote fetal ultrasonography and home monitoring of uterine activity accurately portraying fetal anomalies and uterine contractility.^14-17 Colposcopy provides similar visual information about a woman’s gynecologic health. The parameters for successful telemedical image interpretation have been established for these other fields by studying the correlation between the telemedicine image and the conventional diagnostic modality.^11-13,18-23

The purpose of our project was to demonstrate the technical performance and clinical feasibility of a low-end telecolposcopic system in a rural mountainous environment. Our primary goal was to determine if the transmission of colposcopic images was technically feasible and would be accurately received in an environment where the ground terrain prohibits radio wave and some satellite transmissions. Our secondary goals were to determine whether the telecolposcopy system could be incorporated into a busy medical office with minimal disruption and to determine how it affects the woman’s perceptions of the colposcopic examination. We included several questions to determine how far each woman was willing to travel to see the expert in person rather than participate in telecolposcopy.

Methods

The Review and Remote Site Selection

The review site was based at the Dartmouth Hitchcock Medical Center (DHMC), where an experienced colposcopist reviewed all images. Two remote sites were chosen for this feasibility study: The first site was a single-physician practice located in rural New Hampshire; the second site was an urban residency training clinic remote from DHMC.*

The telecolposcopic system was designed to maximize the quality of digitized images viewed during the examination and deliver those images electronically to the review center. The computer system was installed by the computer support personnel at each remote site in less than 2 hours, and included a brief introduction to the software and 3 to 5 trial runs with mock patients. Computer support personnel visited both sites one additional time during the study to answer software, hardware, and transmission questions. Our study received approval from the Committee on Protection of Human Subjects from Dartmouth Medical School.

A provider survey was designed to document the learning curve of the computer-based digital colposcopic system in an office with limited computer support available (site 1). A 23-question patient satisfaction survey was administered in 2 parts to assess the acceptability of telecolposcopy to women undergoing a colposcopic examination.

Implementation of the Telecolposcopic System

Any woman 18 years or older and scheduled for colposcopy was eligible for enrollment in the study between October 1997 and May 1998. There were no other inclusion or exclusion criteria. After consent was obtained, the woman was given patient education materials to read and asked to complete the first part of the survey. The colposcopic examination was completed as usual, except that images were focused and captured throughout the examination to document the visualization of the entire squamocolumnar junction (SCJ), transformation zone, and any visible lesions in the anogenital area. The colposcopist entered a follow-up plan in the computerized patient record. The images and history were then printed for the patient’s chart. The patient was asked to complete the second part of the satisfaction questionnaire before dismissal, and the physician was asked to complete the provider satisfaction questionnaire. The woman’s cytology and histology results were processed and read by the site’s routine pathology laboratory and were entered into the study database. The review site colposcopist was blinded to the primary colposcopist’s impressions, the woman’s cytology and histology, and any information on the questionnaires.

Statistical Analysis

Our study has a 90% power to determine a statistically significant k correlation, at the 0.05 2-tailed level, between the remote and review site colposcopists’ identification of the SCJ and their impressions of lesion severity and between each colposcopist’s impression and pathology. We used k correlation, independent and paired t tests, and descriptive statistics in this study. All statistics were calculated with Statistica (StatSoft, Tulsa, Oklahoma).²⁴

Results

A total of 79 women participated in our study. Sites 1 and 2 captured images of 39 and 40 women, respectively, representing 100% of the women scheduled for colposcopy at each site during the study. All women were white and ranged in age from 18 to 57 years, with a mean age of 29.5 years (standard deviation=11.5). Thirty-five percent of the women received their colposcopy at their usual site of gynecologic health care; the others were referred from outside offices where colposcopy was not available. The [Table] shows the descriptive data of the women participating in the project: 79% had a history of previous abnormal anogenital lesions; 65% presented with either atypical squamous cells of undetermined significance or low-grade squamous intraepithelial lesion (LSIL) cytology, and approximately 20% had a CIN 2/3 lesion histologically.

Technical Feasibility

The number of images captured for each patient varied from 3 to 20, and the details of the patient’s gynecologic history varied from the current visit data to an extensive past medical and gynecologic history. The average time for transmission of one patient’s images was 6 minutes.

Technical feasibility was measured by the percentage of agreement between the review and both remote sites for colposcopic impressions and histology correlates. A k value greater than 0.75 denotes excellent agreement, between 0.4 and 0.75 is good agreement, and below 0.4 is marginal agreement.25 For all examinations, the physician at the remote sites attempted to capture the SCJ for transmission. The SCJ was noted as “completely visualized” or “not visualized.” There was 86% agreement in complete visualization of the SCJ between the review and the remote sites (k=.533; 95% confidence interval [CI], 0.276-0.791; P=.019).

Both remote and review site physicians classified the colposcopic cervical impression as normal, LSIL, or high-grade-squamous intraepithelial lesion (HSIL). The interobserver agreement for colposcopic impressions was 86% (k=.684; 95% CI, 0.544-0.825; P <.001), and 66% for colposcopic impressions with exact histology (k=.416; 95% CI, 0.323-0.509; P <.001). If agreement between colposcopic impression and histology was relaxed to within 1 degree of severity, there was an 86% interobserver correlation (k=0.78; 95% CI, 0.697-0.861; P <.001). The distinction between normal metaplastic epithelium and low-grade changes accounted for all the discrepancies.

In our study, the implementation of a telecolposcopy system within the current office structure was easily accomplished, and most women accepted the telecolposcopic examination.* A total of 90.5% of the women surveyed travel 25 miles or less to their usual site of general health care; 88.1% traveled 25 miles or less for their colposcopy appointment. When the women were asked to choose whether they would prefer to have a colposcopy done locally and have the images electronically sent to another physician to be reviewed or drive farther than usual to the nearest experienced colposcopist, 95.2% of the women stated that they would have their colposcopy locally with electronic submission if the experienced colposcopist were more than 25 miles away. For the 12% of women who traveled more than 25 miles for their scheduled colposcopy, all stated they would have colposcopy locally if the experienced colposcopist was farther away than their current colposcopist.

Discussion

The telecolposcopy system captured the SCJ extremely well. Our study had an interobserver correlation of SCJ visualization similar to that seen for comparisons between different readers of the same cervigram image.^26,27 To compare between review and remote sites, the colposcopist at site 1 determined the impression while at the colposcope, and the colposcopist at the review center used the same patient’s digital image. The interobserver agreement for our colposcopic image versus digital image colposcopic impressions (86%) was higher than that when both colposcopic impressions were read from colpophotographs.²⁸ Our interobserver correlations between the colposcopic impression and histology agreed with others’ correlations for exact histologic agreement^29,30 (66%) references and was within 1 degree of disease severity (86%) reference number.³¹ The difference in interobserver agreements for the colposcopic impression and histology correlates reflects the difficulty in determining normal metaplasia from low-grade disease, a more difficult distinction than that between normal and high-grade or cancer disease.^8,28

Implementation of any organizational change within a medical office can often be difficult. It is more easily accepted when the organizational change is part of a clinical study.³² Both remote sites adopted the full telecolposcopic system (patient history data and image collection) after our study, because the teaching system, consultation reports, and record documentation were superior to the previous systems. Our study initially gave them the support and structure to use the telecolposcopic system. Implicit in adopting a new computerized system is the availability of someone to troubleshoot software and hardware problems. A remote telecolposcopic system requires that the main technical support comes from the review center, with onsite local technical help available, if necessary. In our study, technical help provided by the review center successfully kept the remote telecolposcopy systems functional with minimal effort.

More than two thirds of the women in our study were referred from their usual site of gynecologic health care to the colposcopist, and most traveled 25 miles or less to keep the appointment. Other studies have shown that women will drive more than 200 miles to participate in health care screening activities.³³ We have shown that when given the choice of a local provider with telecolposcopy access or driving more than 25 miles for an experienced examination, 95% of the women preferred to receive their care from a local colposcopist. This implies that for women in rural communities, local access to colposcopy with telecolposcopic links is preferred to traveling to a distant center of colposcopic excellence. Future efforts at increasing access to colposcopy for women should be directed toward local telecolposcopic connections with a regional center of excellence for image referral.

Conclusions

We have demonstrated that telecolposcopy is feasible, can be implemented in mountainous rural office sites, and is acceptable to the women undergoing the examination. To move from a demonstration project to a regional telecolposcopic network, telemedicine standards established for all telespecialties must be followed, including appropriate licensure and encryption standards.³⁴ Following these standards, the telecolposcopic network has the potential to offer increased access to and improved accuracy of colposcopic services. In addition, as an educational tool telecolposcopic images can be used for medical student, resident, and continuing medical education instruction, as well as direct patient education. Colposcopic training within an obstetrics and gynecology or family medicine residency training program occupies a small proportion of the curriculum. Telecolposcopy can be used to assist residents and other health care providers located at remote sites by providing access to experienced faculty and a large database of patients to review. The digital cervical images, if focused correctly, can provide more detail than the current hand-drawn documentation, which may lead to better cytologic, colposcopic, and histologic correlation.⁹

Colposcopists who as individuals perform a small number of colposcopies can gain knowledge from communicating between practices with the other single colposcopists through this network. They can all then anonymously compare their diagnoses with the actual biopsy result as a voluntary quality assurance and improvement program. This benchmarking can provide the groundwork for national colposcopic standards, as has been done in other countries^35,36 and in the United States for mammographic image and histology correlations.³⁷ The telecolposcopic system could focus on increasing access to colposcopy and on improving colposcopic pattern recognition skills so that high-grade disease would be targeted for treatment, and the overtreatment of low-grade disease would be avoided.

Acknowledgments

The New Hampshire Health Care Transition Fund Grant 98136, the Koop Institute, the Robert Wood Johnson Foundation, and the Division of Gynecologic Oncology, Dartmouth Medical School, have supported this work.

The goal of colposcopy is to identify women with high-grade disease through appropriately targeted biopsy and to correlate the cytologic-colposcopic-histologic results into a cohesive and appropriate management strategy. Approximately 80% of gynecologists and 10% of family physicians in New Hampshire currently provide access to colposcopy. These physicians have a desire to network to improve their colposcopic accuracy.¹ Little work has been published either to define adequate access to colposcopy for any population of women or to improve colposcopic accuracy. Active maintenance and improvement of colposcopic skills are important, because they deteriorate after initial training. Several studies have reported lower than 50% sensitivity for detecting the quadrant of the cervix where the cervical intraepithelial neoplasia (CIN) is present.^2-4 “See and treat” electrosurgical loop excision procedures have resulted in up to 50% of the specimens being histologically normal.^5-9 These high rates of inaccuracy happen because of colposcopists’ inability to distinguish normal from abnormal cervical tissue. Without a dedicated desire to maintain and improve their skills, colposcopists may inadvertently overtreat women on the pretext of preventing cervical cancer.

One potential method for improving colposcopic recognition skills is the development of a network of telecolposcopists who share patient histories, colposcopic images, and histology correlations on a routine basis. Before determining whether this network would improve colposcopic care, it must first be shown that telecolposcopic images can be transmitted to and recognized accurately at the reception site.

Radiologists, dermatologists, pathologists, and psychiatrists^10-13 have accurately relayed image transmissions. The fields of otorhinolaryngology, ophthalmology, cardiology, pulmonology, and emergency medicine have also reported telemedicine capabilities during the past few years. Teleobstetrics has demonstrated the feasibility of remote fetal ultrasonography and home monitoring of uterine activity accurately portraying fetal anomalies and uterine contractility.^14-17 Colposcopy provides similar visual information about a woman’s gynecologic health. The parameters for successful telemedical image interpretation have been established for these other fields by studying the correlation between the telemedicine image and the conventional diagnostic modality.^11-13,18-23

The purpose of our project was to demonstrate the technical performance and clinical feasibility of a low-end telecolposcopic system in a rural mountainous environment. Our primary goal was to determine if the transmission of colposcopic images was technically feasible and would be accurately received in an environment where the ground terrain prohibits radio wave and some satellite transmissions. Our secondary goals were to determine whether the telecolposcopy system could be incorporated into a busy medical office with minimal disruption and to determine how it affects the woman’s perceptions of the colposcopic examination. We included several questions to determine how far each woman was willing to travel to see the expert in person rather than participate in telecolposcopy.

Methods

The Review and Remote Site Selection

The review site was based at the Dartmouth Hitchcock Medical Center (DHMC), where an experienced colposcopist reviewed all images. Two remote sites were chosen for this feasibility study: The first site was a single-physician practice located in rural New Hampshire; the second site was an urban residency training clinic remote from DHMC.*

The telecolposcopic system was designed to maximize the quality of digitized images viewed during the examination and deliver those images electronically to the review center. The computer system was installed by the computer support personnel at each remote site in less than 2 hours, and included a brief introduction to the software and 3 to 5 trial runs with mock patients. Computer support personnel visited both sites one additional time during the study to answer software, hardware, and transmission questions. Our study received approval from the Committee on Protection of Human Subjects from Dartmouth Medical School.

A provider survey was designed to document the learning curve of the computer-based digital colposcopic system in an office with limited computer support available (site 1). A 23-question patient satisfaction survey was administered in 2 parts to assess the acceptability of telecolposcopy to women undergoing a colposcopic examination.

Implementation of the Telecolposcopic System

Any woman 18 years or older and scheduled for colposcopy was eligible for enrollment in the study between October 1997 and May 1998. There were no other inclusion or exclusion criteria. After consent was obtained, the woman was given patient education materials to read and asked to complete the first part of the survey. The colposcopic examination was completed as usual, except that images were focused and captured throughout the examination to document the visualization of the entire squamocolumnar junction (SCJ), transformation zone, and any visible lesions in the anogenital area. The colposcopist entered a follow-up plan in the computerized patient record. The images and history were then printed for the patient’s chart. The patient was asked to complete the second part of the satisfaction questionnaire before dismissal, and the physician was asked to complete the provider satisfaction questionnaire. The woman’s cytology and histology results were processed and read by the site’s routine pathology laboratory and were entered into the study database. The review site colposcopist was blinded to the primary colposcopist’s impressions, the woman’s cytology and histology, and any information on the questionnaires.

Statistical Analysis

Our study has a 90% power to determine a statistically significant k correlation, at the 0.05 2-tailed level, between the remote and review site colposcopists’ identification of the SCJ and their impressions of lesion severity and between each colposcopist’s impression and pathology. We used k correlation, independent and paired t tests, and descriptive statistics in this study. All statistics were calculated with Statistica (StatSoft, Tulsa, Oklahoma).²⁴

Results

A total of 79 women participated in our study. Sites 1 and 2 captured images of 39 and 40 women, respectively, representing 100% of the women scheduled for colposcopy at each site during the study. All women were white and ranged in age from 18 to 57 years, with a mean age of 29.5 years (standard deviation=11.5). Thirty-five percent of the women received their colposcopy at their usual site of gynecologic health care; the others were referred from outside offices where colposcopy was not available. The [Table] shows the descriptive data of the women participating in the project: 79% had a history of previous abnormal anogenital lesions; 65% presented with either atypical squamous cells of undetermined significance or low-grade squamous intraepithelial lesion (LSIL) cytology, and approximately 20% had a CIN 2/3 lesion histologically.

Technical Feasibility

The number of images captured for each patient varied from 3 to 20, and the details of the patient’s gynecologic history varied from the current visit data to an extensive past medical and gynecologic history. The average time for transmission of one patient’s images was 6 minutes.

Technical feasibility was measured by the percentage of agreement between the review and both remote sites for colposcopic impressions and histology correlates. A k value greater than 0.75 denotes excellent agreement, between 0.4 and 0.75 is good agreement, and below 0.4 is marginal agreement.25 For all examinations, the physician at the remote sites attempted to capture the SCJ for transmission. The SCJ was noted as “completely visualized” or “not visualized.” There was 86% agreement in complete visualization of the SCJ between the review and the remote sites (k=.533; 95% confidence interval [CI], 0.276-0.791; P=.019).

Both remote and review site physicians classified the colposcopic cervical impression as normal, LSIL, or high-grade-squamous intraepithelial lesion (HSIL). The interobserver agreement for colposcopic impressions was 86% (k=.684; 95% CI, 0.544-0.825; P <.001), and 66% for colposcopic impressions with exact histology (k=.416; 95% CI, 0.323-0.509; P <.001). If agreement between colposcopic impression and histology was relaxed to within 1 degree of severity, there was an 86% interobserver correlation (k=0.78; 95% CI, 0.697-0.861; P <.001). The distinction between normal metaplastic epithelium and low-grade changes accounted for all the discrepancies.

In our study, the implementation of a telecolposcopy system within the current office structure was easily accomplished, and most women accepted the telecolposcopic examination.* A total of 90.5% of the women surveyed travel 25 miles or less to their usual site of general health care; 88.1% traveled 25 miles or less for their colposcopy appointment. When the women were asked to choose whether they would prefer to have a colposcopy done locally and have the images electronically sent to another physician to be reviewed or drive farther than usual to the nearest experienced colposcopist, 95.2% of the women stated that they would have their colposcopy locally with electronic submission if the experienced colposcopist were more than 25 miles away. For the 12% of women who traveled more than 25 miles for their scheduled colposcopy, all stated they would have colposcopy locally if the experienced colposcopist was farther away than their current colposcopist.

Discussion

The telecolposcopy system captured the SCJ extremely well. Our study had an interobserver correlation of SCJ visualization similar to that seen for comparisons between different readers of the same cervigram image.^26,27 To compare between review and remote sites, the colposcopist at site 1 determined the impression while at the colposcope, and the colposcopist at the review center used the same patient’s digital image. The interobserver agreement for our colposcopic image versus digital image colposcopic impressions (86%) was higher than that when both colposcopic impressions were read from colpophotographs.²⁸ Our interobserver correlations between the colposcopic impression and histology agreed with others’ correlations for exact histologic agreement^29,30 (66%) references and was within 1 degree of disease severity (86%) reference number.³¹ The difference in interobserver agreements for the colposcopic impression and histology correlates reflects the difficulty in determining normal metaplasia from low-grade disease, a more difficult distinction than that between normal and high-grade or cancer disease.^8,28

Implementation of any organizational change within a medical office can often be difficult. It is more easily accepted when the organizational change is part of a clinical study.³² Both remote sites adopted the full telecolposcopic system (patient history data and image collection) after our study, because the teaching system, consultation reports, and record documentation were superior to the previous systems. Our study initially gave them the support and structure to use the telecolposcopic system. Implicit in adopting a new computerized system is the availability of someone to troubleshoot software and hardware problems. A remote telecolposcopic system requires that the main technical support comes from the review center, with onsite local technical help available, if necessary. In our study, technical help provided by the review center successfully kept the remote telecolposcopy systems functional with minimal effort.

More than two thirds of the women in our study were referred from their usual site of gynecologic health care to the colposcopist, and most traveled 25 miles or less to keep the appointment. Other studies have shown that women will drive more than 200 miles to participate in health care screening activities.³³ We have shown that when given the choice of a local provider with telecolposcopy access or driving more than 25 miles for an experienced examination, 95% of the women preferred to receive their care from a local colposcopist. This implies that for women in rural communities, local access to colposcopy with telecolposcopic links is preferred to traveling to a distant center of colposcopic excellence. Future efforts at increasing access to colposcopy for women should be directed toward local telecolposcopic connections with a regional center of excellence for image referral.

Conclusions

We have demonstrated that telecolposcopy is feasible, can be implemented in mountainous rural office sites, and is acceptable to the women undergoing the examination. To move from a demonstration project to a regional telecolposcopic network, telemedicine standards established for all telespecialties must be followed, including appropriate licensure and encryption standards.³⁴ Following these standards, the telecolposcopic network has the potential to offer increased access to and improved accuracy of colposcopic services. In addition, as an educational tool telecolposcopic images can be used for medical student, resident, and continuing medical education instruction, as well as direct patient education. Colposcopic training within an obstetrics and gynecology or family medicine residency training program occupies a small proportion of the curriculum. Telecolposcopy can be used to assist residents and other health care providers located at remote sites by providing access to experienced faculty and a large database of patients to review. The digital cervical images, if focused correctly, can provide more detail than the current hand-drawn documentation, which may lead to better cytologic, colposcopic, and histologic correlation.⁹

Colposcopists who as individuals perform a small number of colposcopies can gain knowledge from communicating between practices with the other single colposcopists through this network. They can all then anonymously compare their diagnoses with the actual biopsy result as a voluntary quality assurance and improvement program. This benchmarking can provide the groundwork for national colposcopic standards, as has been done in other countries^35,36 and in the United States for mammographic image and histology correlations.³⁷ The telecolposcopic system could focus on increasing access to colposcopy and on improving colposcopic pattern recognition skills so that high-grade disease would be targeted for treatment, and the overtreatment of low-grade disease would be avoided.

Acknowledgments

The New Hampshire Health Care Transition Fund Grant 98136, the Koop Institute, the Robert Wood Johnson Foundation, and the Division of Gynecologic Oncology, Dartmouth Medical School, have supported this work.

The goal of colposcopy is to identify women with high-grade disease through appropriately targeted biopsy and to correlate the cytologic-colposcopic-histologic results into a cohesive and appropriate management strategy. Approximately 80% of gynecologists and 10% of family physicians in New Hampshire currently provide access to colposcopy. These physicians have a desire to network to improve their colposcopic accuracy.¹ Little work has been published either to define adequate access to colposcopy for any population of women or to improve colposcopic accuracy. Active maintenance and improvement of colposcopic skills are important, because they deteriorate after initial training. Several studies have reported lower than 50% sensitivity for detecting the quadrant of the cervix where the cervical intraepithelial neoplasia (CIN) is present.^2-4 “See and treat” electrosurgical loop excision procedures have resulted in up to 50% of the specimens being histologically normal.^5-9 These high rates of inaccuracy happen because of colposcopists’ inability to distinguish normal from abnormal cervical tissue. Without a dedicated desire to maintain and improve their skills, colposcopists may inadvertently overtreat women on the pretext of preventing cervical cancer.

One potential method for improving colposcopic recognition skills is the development of a network of telecolposcopists who share patient histories, colposcopic images, and histology correlations on a routine basis. Before determining whether this network would improve colposcopic care, it must first be shown that telecolposcopic images can be transmitted to and recognized accurately at the reception site.

Radiologists, dermatologists, pathologists, and psychiatrists^10-13 have accurately relayed image transmissions. The fields of otorhinolaryngology, ophthalmology, cardiology, pulmonology, and emergency medicine have also reported telemedicine capabilities during the past few years. Teleobstetrics has demonstrated the feasibility of remote fetal ultrasonography and home monitoring of uterine activity accurately portraying fetal anomalies and uterine contractility.^14-17 Colposcopy provides similar visual information about a woman’s gynecologic health. The parameters for successful telemedical image interpretation have been established for these other fields by studying the correlation between the telemedicine image and the conventional diagnostic modality.^11-13,18-23

The purpose of our project was to demonstrate the technical performance and clinical feasibility of a low-end telecolposcopic system in a rural mountainous environment. Our primary goal was to determine if the transmission of colposcopic images was technically feasible and would be accurately received in an environment where the ground terrain prohibits radio wave and some satellite transmissions. Our secondary goals were to determine whether the telecolposcopy system could be incorporated into a busy medical office with minimal disruption and to determine how it affects the woman’s perceptions of the colposcopic examination. We included several questions to determine how far each woman was willing to travel to see the expert in person rather than participate in telecolposcopy.

Methods

The Review and Remote Site Selection

The review site was based at the Dartmouth Hitchcock Medical Center (DHMC), where an experienced colposcopist reviewed all images. Two remote sites were chosen for this feasibility study: The first site was a single-physician practice located in rural New Hampshire; the second site was an urban residency training clinic remote from DHMC.*

The telecolposcopic system was designed to maximize the quality of digitized images viewed during the examination and deliver those images electronically to the review center. The computer system was installed by the computer support personnel at each remote site in less than 2 hours, and included a brief introduction to the software and 3 to 5 trial runs with mock patients. Computer support personnel visited both sites one additional time during the study to answer software, hardware, and transmission questions. Our study received approval from the Committee on Protection of Human Subjects from Dartmouth Medical School.

A provider survey was designed to document the learning curve of the computer-based digital colposcopic system in an office with limited computer support available (site 1). A 23-question patient satisfaction survey was administered in 2 parts to assess the acceptability of telecolposcopy to women undergoing a colposcopic examination.

Implementation of the Telecolposcopic System

Any woman 18 years or older and scheduled for colposcopy was eligible for enrollment in the study between October 1997 and May 1998. There were no other inclusion or exclusion criteria. After consent was obtained, the woman was given patient education materials to read and asked to complete the first part of the survey. The colposcopic examination was completed as usual, except that images were focused and captured throughout the examination to document the visualization of the entire squamocolumnar junction (SCJ), transformation zone, and any visible lesions in the anogenital area. The colposcopist entered a follow-up plan in the computerized patient record. The images and history were then printed for the patient’s chart. The patient was asked to complete the second part of the satisfaction questionnaire before dismissal, and the physician was asked to complete the provider satisfaction questionnaire. The woman’s cytology and histology results were processed and read by the site’s routine pathology laboratory and were entered into the study database. The review site colposcopist was blinded to the primary colposcopist’s impressions, the woman’s cytology and histology, and any information on the questionnaires.

Statistical Analysis

Our study has a 90% power to determine a statistically significant k correlation, at the 0.05 2-tailed level, between the remote and review site colposcopists’ identification of the SCJ and their impressions of lesion severity and between each colposcopist’s impression and pathology. We used k correlation, independent and paired t tests, and descriptive statistics in this study. All statistics were calculated with Statistica (StatSoft, Tulsa, Oklahoma).²⁴

Results

A total of 79 women participated in our study. Sites 1 and 2 captured images of 39 and 40 women, respectively, representing 100% of the women scheduled for colposcopy at each site during the study. All women were white and ranged in age from 18 to 57 years, with a mean age of 29.5 years (standard deviation=11.5). Thirty-five percent of the women received their colposcopy at their usual site of gynecologic health care; the others were referred from outside offices where colposcopy was not available. The [Table] shows the descriptive data of the women participating in the project: 79% had a history of previous abnormal anogenital lesions; 65% presented with either atypical squamous cells of undetermined significance or low-grade squamous intraepithelial lesion (LSIL) cytology, and approximately 20% had a CIN 2/3 lesion histologically.

Technical Feasibility

The number of images captured for each patient varied from 3 to 20, and the details of the patient’s gynecologic history varied from the current visit data to an extensive past medical and gynecologic history. The average time for transmission of one patient’s images was 6 minutes.

Technical feasibility was measured by the percentage of agreement between the review and both remote sites for colposcopic impressions and histology correlates. A k value greater than 0.75 denotes excellent agreement, between 0.4 and 0.75 is good agreement, and below 0.4 is marginal agreement.25 For all examinations, the physician at the remote sites attempted to capture the SCJ for transmission. The SCJ was noted as “completely visualized” or “not visualized.” There was 86% agreement in complete visualization of the SCJ between the review and the remote sites (k=.533; 95% confidence interval [CI], 0.276-0.791; P=.019).

Both remote and review site physicians classified the colposcopic cervical impression as normal, LSIL, or high-grade-squamous intraepithelial lesion (HSIL). The interobserver agreement for colposcopic impressions was 86% (k=.684; 95% CI, 0.544-0.825; P <.001), and 66% for colposcopic impressions with exact histology (k=.416; 95% CI, 0.323-0.509; P <.001). If agreement between colposcopic impression and histology was relaxed to within 1 degree of severity, there was an 86% interobserver correlation (k=0.78; 95% CI, 0.697-0.861; P <.001). The distinction between normal metaplastic epithelium and low-grade changes accounted for all the discrepancies.

In our study, the implementation of a telecolposcopy system within the current office structure was easily accomplished, and most women accepted the telecolposcopic examination.* A total of 90.5% of the women surveyed travel 25 miles or less to their usual site of general health care; 88.1% traveled 25 miles or less for their colposcopy appointment. When the women were asked to choose whether they would prefer to have a colposcopy done locally and have the images electronically sent to another physician to be reviewed or drive farther than usual to the nearest experienced colposcopist, 95.2% of the women stated that they would have their colposcopy locally with electronic submission if the experienced colposcopist were more than 25 miles away. For the 12% of women who traveled more than 25 miles for their scheduled colposcopy, all stated they would have colposcopy locally if the experienced colposcopist was farther away than their current colposcopist.

Discussion

The telecolposcopy system captured the SCJ extremely well. Our study had an interobserver correlation of SCJ visualization similar to that seen for comparisons between different readers of the same cervigram image.^26,27 To compare between review and remote sites, the colposcopist at site 1 determined the impression while at the colposcope, and the colposcopist at the review center used the same patient’s digital image. The interobserver agreement for our colposcopic image versus digital image colposcopic impressions (86%) was higher than that when both colposcopic impressions were read from colpophotographs.²⁸ Our interobserver correlations between the colposcopic impression and histology agreed with others’ correlations for exact histologic agreement^29,30 (66%) references and was within 1 degree of disease severity (86%) reference number.³¹ The difference in interobserver agreements for the colposcopic impression and histology correlates reflects the difficulty in determining normal metaplasia from low-grade disease, a more difficult distinction than that between normal and high-grade or cancer disease.^8,28

Implementation of any organizational change within a medical office can often be difficult. It is more easily accepted when the organizational change is part of a clinical study.³² Both remote sites adopted the full telecolposcopic system (patient history data and image collection) after our study, because the teaching system, consultation reports, and record documentation were superior to the previous systems. Our study initially gave them the support and structure to use the telecolposcopic system. Implicit in adopting a new computerized system is the availability of someone to troubleshoot software and hardware problems. A remote telecolposcopic system requires that the main technical support comes from the review center, with onsite local technical help available, if necessary. In our study, technical help provided by the review center successfully kept the remote telecolposcopy systems functional with minimal effort.

More than two thirds of the women in our study were referred from their usual site of gynecologic health care to the colposcopist, and most traveled 25 miles or less to keep the appointment. Other studies have shown that women will drive more than 200 miles to participate in health care screening activities.³³ We have shown that when given the choice of a local provider with telecolposcopy access or driving more than 25 miles for an experienced examination, 95% of the women preferred to receive their care from a local colposcopist. This implies that for women in rural communities, local access to colposcopy with telecolposcopic links is preferred to traveling to a distant center of colposcopic excellence. Future efforts at increasing access to colposcopy for women should be directed toward local telecolposcopic connections with a regional center of excellence for image referral.

Conclusions

We have demonstrated that telecolposcopy is feasible, can be implemented in mountainous rural office sites, and is acceptable to the women undergoing the examination. To move from a demonstration project to a regional telecolposcopic network, telemedicine standards established for all telespecialties must be followed, including appropriate licensure and encryption standards.³⁴ Following these standards, the telecolposcopic network has the potential to offer increased access to and improved accuracy of colposcopic services. In addition, as an educational tool telecolposcopic images can be used for medical student, resident, and continuing medical education instruction, as well as direct patient education. Colposcopic training within an obstetrics and gynecology or family medicine residency training program occupies a small proportion of the curriculum. Telecolposcopy can be used to assist residents and other health care providers located at remote sites by providing access to experienced faculty and a large database of patients to review. The digital cervical images, if focused correctly, can provide more detail than the current hand-drawn documentation, which may lead to better cytologic, colposcopic, and histologic correlation.⁹

Colposcopists who as individuals perform a small number of colposcopies can gain knowledge from communicating between practices with the other single colposcopists through this network. They can all then anonymously compare their diagnoses with the actual biopsy result as a voluntary quality assurance and improvement program. This benchmarking can provide the groundwork for national colposcopic standards, as has been done in other countries^35,36 and in the United States for mammographic image and histology correlations.³⁷ The telecolposcopic system could focus on increasing access to colposcopy and on improving colposcopic pattern recognition skills so that high-grade disease would be targeted for treatment, and the overtreatment of low-grade disease would be avoided.

Acknowledgments

The New Hampshire Health Care Transition Fund Grant 98136, the Koop Institute, the Robert Wood Johnson Foundation, and the Division of Gynecologic Oncology, Dartmouth Medical School, have supported this work.