The Natural History of Cervical Cryosurgical Healing

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Original Research

The Natural History of Cervical Cryosurgical Healing

J Fam Pract. 2000 August;49(8):694-700

References

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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).