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METHODS: We conducted a prospective multicentered trial in which women who had a histologically documented CIN lesion underwent cervical cryosurgery. Forty-six women were randomized to undergo eschar debridement at 48 hours after cryosurgery, and 38 women received standard care. All women were followed up and given preweighed sanitary pads for hydrorrhea (watery discharge) collection and a diary to record the severity and number of days of odor, pain, cramping, and hydrorrhea that were experienced.
RESULTS: The average total amount of hydrorrhea or discharge was 288 g, which required using an average of 41 sanitary pads during a period of 12.4 days. The duration of odor was 8.9 days, and the pain and cramping experienced after cryosurgery lasted 4.7 days. Women who were obese had greater hydrorrhea and pad usage than nonobese women. Debridement of the cervical eschar did not significantly change the signs and symptoms of healing after cryosurgery.
CONCLUSIONS: There are significant symptoms patients experience after cryosurgery that are not ameliorated by debridement. The expectations of the cryosurgical healing process should be disclosed to women before the procedure.
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.
1. H, Koudstall J, Oosterhuis JW, Wymenga HA, Aalders JG, Janssens J. Analysis of cryolesions in the uterine cervix: application techniques, extension, and failures. Obstet Gynecol 1990;75:232-39.
2. H, Aalders JG, Koudstall J, Oosterhuis JW, Janssens J. Minimum extension and appropriate topographic position of tissue destruction for treatment of cervical intraepithelial neoplasia. Obstet Gynecol 1990;75:227-31.
3. KD. Cryotherapy. Bailliers Clin Obstet Gynaecol 1995;9:133-43.
4. DM, Mayeaux EJ, Daaleman TP, Johnson CA. Healing experiences after cervical cryosurgery: implications for informed consent. J Fam Pract 2000;49:700-706.
5. D, Newkirk GR. Cervical cryotherapy. In: Newkirk GR, ed. Colposcopy for the family physician. Including colposcopy, cryotherapy and loop electrosurgery: a self-study program for the family physician interested in colposcopy. Kansas City, Mo: American Academy of Family Physicians; 1994;293.-
6. MY, Maklebust J. Debridement: choices and challenges. Adv Wound Care 1997;10:32-37.
7. IS, McCarron G, Markham R. A preliminary study of factors influencing perception of menstrual blood loss amount. Am J Obstet Gynecol 1984;149:788-90.
8. JM, Shaw RW. Clinical associations with objective menstrual blood amount. Eur J Obstet Gynecol Reprod Biol 1999;82:73-76.
9. IS, McCarron G, Markham R, Resta T. Blood and total fluid content of menstrual hydrorrhea. Obstet Gynecol 1985;65:194-97.
10. DR. Abnormal uterine bleeding. In : Mishell DR Stenchever MA, Droegemueller W, Herbst AL. Comprehensive gynecology. 3rd edition. Boston, Mass: Mosby, 1997;1025-42.
11. SK, Billwicz WZ, Thomson AM. Sources of variation in menstrual blood loss. J Obstet Gynaecol Br Commonwlth 1971;78:933-35.
12. R, Teperi J, Turpeinen U, et al. Combined laboratory and diary method for objective assessment of menstrual blood loss. Acta Obstet Gynecol Scand 1998;77:201-04.
13. L, Ylikorkala O. Menstrual blood loss in dysmenorrhoea: effects of proquazone and indomethacin. Br J Obstet Gynaecol 1983;90:570-72.
14. PJ, Hodgson H, Anderson ABM, Turnbull AC. Measurement of menstrual blood loss in patients complaining of menorrhagia. Br J Obstet Gynaecol 1977;84:763-65.
15. G, Milsom I, Andersch B. Factors influencing the prevalence and severity of dysmenorrhoea in young women. Br J Obstet Gynaecol 1990;97:588-94.
16. SD, Park M. A longitudinal study of risk factors for the occurrence, duration and severity of menstrual cramps in a cohort of college women. Br J Obstet Gynaecol 1996;103:1134-42.
17. WA, Whitney CW, Rine J. Evaluation of removing devitalized cervical tissue in the reduction of vaginal hydrorrhea after cervical cryotherapy. J Reprod Med. 1981;26:263-64.
18. M. Obesity as an intrinsic factor affecting wound healing. J Wound Care 1998;7:220-21.
19. SM. Morbid obesity: a chronic disease with an impact on wounds and related problems. Ostomy Wound Manage 1997;43:18-24,26-7.
20. S. Promotion of epithelialization of the uterine cervix surface following cryotherapy. Acta Chirurgica Hungarica 1992;33:187-89.
21. EG, Webb W. Effects of systemic corticosteroids on post-cryosurgical edema and other manifestations of the inflammatory response. J Derm Surg Onc 1985;11:464-68.
METHODS: We conducted a prospective multicentered trial in which women who had a histologically documented CIN lesion underwent cervical cryosurgery. Forty-six women were randomized to undergo eschar debridement at 48 hours after cryosurgery, and 38 women received standard care. All women were followed up and given preweighed sanitary pads for hydrorrhea (watery discharge) collection and a diary to record the severity and number of days of odor, pain, cramping, and hydrorrhea that were experienced.
RESULTS: The average total amount of hydrorrhea or discharge was 288 g, which required using an average of 41 sanitary pads during a period of 12.4 days. The duration of odor was 8.9 days, and the pain and cramping experienced after cryosurgery lasted 4.7 days. Women who were obese had greater hydrorrhea and pad usage than nonobese women. Debridement of the cervical eschar did not significantly change the signs and symptoms of healing after cryosurgery.
CONCLUSIONS: There are significant symptoms patients experience after cryosurgery that are not ameliorated by debridement. The expectations of the cryosurgical healing process should be disclosed to women before the procedure.
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.
METHODS: We conducted a prospective multicentered trial in which women who had a histologically documented CIN lesion underwent cervical cryosurgery. Forty-six women were randomized to undergo eschar debridement at 48 hours after cryosurgery, and 38 women received standard care. All women were followed up and given preweighed sanitary pads for hydrorrhea (watery discharge) collection and a diary to record the severity and number of days of odor, pain, cramping, and hydrorrhea that were experienced.
RESULTS: The average total amount of hydrorrhea or discharge was 288 g, which required using an average of 41 sanitary pads during a period of 12.4 days. The duration of odor was 8.9 days, and the pain and cramping experienced after cryosurgery lasted 4.7 days. Women who were obese had greater hydrorrhea and pad usage than nonobese women. Debridement of the cervical eschar did not significantly change the signs and symptoms of healing after cryosurgery.
CONCLUSIONS: There are significant symptoms patients experience after cryosurgery that are not ameliorated by debridement. The expectations of the cryosurgical healing process should be disclosed to women before the procedure.
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.
1. H, Koudstall J, Oosterhuis JW, Wymenga HA, Aalders JG, Janssens J. Analysis of cryolesions in the uterine cervix: application techniques, extension, and failures. Obstet Gynecol 1990;75:232-39.
2. H, Aalders JG, Koudstall J, Oosterhuis JW, Janssens J. Minimum extension and appropriate topographic position of tissue destruction for treatment of cervical intraepithelial neoplasia. Obstet Gynecol 1990;75:227-31.
3. KD. Cryotherapy. Bailliers Clin Obstet Gynaecol 1995;9:133-43.
4. DM, Mayeaux EJ, Daaleman TP, Johnson CA. Healing experiences after cervical cryosurgery: implications for informed consent. J Fam Pract 2000;49:700-706.
5. D, Newkirk GR. Cervical cryotherapy. In: Newkirk GR, ed. Colposcopy for the family physician. Including colposcopy, cryotherapy and loop electrosurgery: a self-study program for the family physician interested in colposcopy. Kansas City, Mo: American Academy of Family Physicians; 1994;293.-
6. MY, Maklebust J. Debridement: choices and challenges. Adv Wound Care 1997;10:32-37.
7. IS, McCarron G, Markham R. A preliminary study of factors influencing perception of menstrual blood loss amount. Am J Obstet Gynecol 1984;149:788-90.
8. JM, Shaw RW. Clinical associations with objective menstrual blood amount. Eur J Obstet Gynecol Reprod Biol 1999;82:73-76.
9. IS, McCarron G, Markham R, Resta T. Blood and total fluid content of menstrual hydrorrhea. Obstet Gynecol 1985;65:194-97.
10. DR. Abnormal uterine bleeding. In : Mishell DR Stenchever MA, Droegemueller W, Herbst AL. Comprehensive gynecology. 3rd edition. Boston, Mass: Mosby, 1997;1025-42.
11. SK, Billwicz WZ, Thomson AM. Sources of variation in menstrual blood loss. J Obstet Gynaecol Br Commonwlth 1971;78:933-35.
12. R, Teperi J, Turpeinen U, et al. Combined laboratory and diary method for objective assessment of menstrual blood loss. Acta Obstet Gynecol Scand 1998;77:201-04.
13. L, Ylikorkala O. Menstrual blood loss in dysmenorrhoea: effects of proquazone and indomethacin. Br J Obstet Gynaecol 1983;90:570-72.
14. PJ, Hodgson H, Anderson ABM, Turnbull AC. Measurement of menstrual blood loss in patients complaining of menorrhagia. Br J Obstet Gynaecol 1977;84:763-65.
15. G, Milsom I, Andersch B. Factors influencing the prevalence and severity of dysmenorrhoea in young women. Br J Obstet Gynaecol 1990;97:588-94.
16. SD, Park M. A longitudinal study of risk factors for the occurrence, duration and severity of menstrual cramps in a cohort of college women. Br J Obstet Gynaecol 1996;103:1134-42.
17. WA, Whitney CW, Rine J. Evaluation of removing devitalized cervical tissue in the reduction of vaginal hydrorrhea after cervical cryotherapy. J Reprod Med. 1981;26:263-64.
18. M. Obesity as an intrinsic factor affecting wound healing. J Wound Care 1998;7:220-21.
19. SM. Morbid obesity: a chronic disease with an impact on wounds and related problems. Ostomy Wound Manage 1997;43:18-24,26-7.
20. S. Promotion of epithelialization of the uterine cervix surface following cryotherapy. Acta Chirurgica Hungarica 1992;33:187-89.
21. EG, Webb W. Effects of systemic corticosteroids on post-cryosurgical edema and other manifestations of the inflammatory response. J Derm Surg Onc 1985;11:464-68.
1. H, Koudstall J, Oosterhuis JW, Wymenga HA, Aalders JG, Janssens J. Analysis of cryolesions in the uterine cervix: application techniques, extension, and failures. Obstet Gynecol 1990;75:232-39.
2. H, Aalders JG, Koudstall J, Oosterhuis JW, Janssens J. Minimum extension and appropriate topographic position of tissue destruction for treatment of cervical intraepithelial neoplasia. Obstet Gynecol 1990;75:227-31.
3. KD. Cryotherapy. Bailliers Clin Obstet Gynaecol 1995;9:133-43.
4. DM, Mayeaux EJ, Daaleman TP, Johnson CA. Healing experiences after cervical cryosurgery: implications for informed consent. J Fam Pract 2000;49:700-706.
5. D, Newkirk GR. Cervical cryotherapy. In: Newkirk GR, ed. Colposcopy for the family physician. Including colposcopy, cryotherapy and loop electrosurgery: a self-study program for the family physician interested in colposcopy. Kansas City, Mo: American Academy of Family Physicians; 1994;293.-
6. MY, Maklebust J. Debridement: choices and challenges. Adv Wound Care 1997;10:32-37.
7. IS, McCarron G, Markham R. A preliminary study of factors influencing perception of menstrual blood loss amount. Am J Obstet Gynecol 1984;149:788-90.
8. JM, Shaw RW. Clinical associations with objective menstrual blood amount. Eur J Obstet Gynecol Reprod Biol 1999;82:73-76.
9. IS, McCarron G, Markham R, Resta T. Blood and total fluid content of menstrual hydrorrhea. Obstet Gynecol 1985;65:194-97.
10. DR. Abnormal uterine bleeding. In : Mishell DR Stenchever MA, Droegemueller W, Herbst AL. Comprehensive gynecology. 3rd edition. Boston, Mass: Mosby, 1997;1025-42.
11. SK, Billwicz WZ, Thomson AM. Sources of variation in menstrual blood loss. J Obstet Gynaecol Br Commonwlth 1971;78:933-35.
12. R, Teperi J, Turpeinen U, et al. Combined laboratory and diary method for objective assessment of menstrual blood loss. Acta Obstet Gynecol Scand 1998;77:201-04.
13. L, Ylikorkala O. Menstrual blood loss in dysmenorrhoea: effects of proquazone and indomethacin. Br J Obstet Gynaecol 1983;90:570-72.
14. PJ, Hodgson H, Anderson ABM, Turnbull AC. Measurement of menstrual blood loss in patients complaining of menorrhagia. Br J Obstet Gynaecol 1977;84:763-65.
15. G, Milsom I, Andersch B. Factors influencing the prevalence and severity of dysmenorrhoea in young women. Br J Obstet Gynaecol 1990;97:588-94.
16. SD, Park M. A longitudinal study of risk factors for the occurrence, duration and severity of menstrual cramps in a cohort of college women. Br J Obstet Gynaecol 1996;103:1134-42.
17. WA, Whitney CW, Rine J. Evaluation of removing devitalized cervical tissue in the reduction of vaginal hydrorrhea after cervical cryotherapy. J Reprod Med. 1981;26:263-64.
18. M. Obesity as an intrinsic factor affecting wound healing. J Wound Care 1998;7:220-21.
19. SM. Morbid obesity: a chronic disease with an impact on wounds and related problems. Ostomy Wound Manage 1997;43:18-24,26-7.
20. S. Promotion of epithelialization of the uterine cervix surface following cryotherapy. Acta Chirurgica Hungarica 1992;33:187-89.
21. EG, Webb W. Effects of systemic corticosteroids on post-cryosurgical edema and other manifestations of the inflammatory response. J Derm Surg Onc 1985;11:464-68.