Materials and Methods
Recruitment
This randomized, controlled clinical study took place at the Women's Health University Hospital, Assiut University, from June 2006 through October 2010. The institutional review board approved the study. Nonpregnant women with clinically evident cervical lesions attending gynecologic, family planning, and infertility clinics were selected for the study; the study was divided into 2 phases.
Clinical Work-up
Phase 1 of the Study. A thorough history was taken with special emphasis on age and parity of the patients, age at and duration of marriage, menstrual pattern, contraceptive history stressed on type and duration of use, contact bleeding or dyspareunia, color and odor of vaginal discharge, pelvic pain, backache or any associated symptoms. In the lithotomy position, a nonlubricated bivalve vaginal speculum was inserted into the vagina. The cervix was cleaned from any secretions or blood using sterile 0.9% saline. A thorough naked-eye assessment of the cervix was done. If a cervical lesion was seen, it was recorded, and its site was marked on a special diagram. Cervical Pap smear was obtained from ectocervix using an Ayer's spatula, and an additional endocervical sample was obtained using endocervical cytobrush. The samples were then immediately plated on a slide, fixed, and stained by modified Pap stain using a hand staining procedure. Each smear was screened using modified Bethesda system terminology[6] and checked for cytological evidence of inflammation and identification of cellular atypia, dysplasia, or carcinoma. All women with cervical lesions were scheduled for colposcopic examination using Karl Kaps Colposcope model (SOM 52, Tubingen, Germany). Colposcopic examination includes 4 steps: saline technique to assess the cervical lesion and vasculature of the cervix with the aid of a green filter, 5% acetic acid technique to determine acetowhite-positive areas, Schiller iodine technique to visualize high glycogen-containing cells, and biopsy. Nevertheless, biopsy was performed in every abnormal colposcopic examination result. After this initial assessment, patients were scheduled to receive empirical treatment for Chlamydia trachomatis infection in the form of azithromycin, in addition to treating any associated vaginal or cervical infection.
Phase 2 of the Study. Women with benign persistent cervical lesions after 1 month were included in this study. Women with preinvasive, microinvasive, or invasive cancer in the cervix were excluded from the study.
Patients meeting the inclusion criteria were counseled about participating in the study. A written informed consent was taken. Patients had the right to refuse to participate and/or withdraw from the study at any time without being denied their regular full clinical care. Personal information as well as data collected were subjected to confidentiality and were not made available to any third party.
Randomization
Patients meeting the inclusion criteria were randomly allocated into 2 groups according to the method of treatment. We used a simple computer-generated randomization sheet. Group A included 126 patients scheduled for monopolar spray coagulation of the cervix. The cervix was cleaned with normal 0.9% saline. Localization of the cervical lesion using acetic acid 5% painting was done. With the use of a long ball-electrode connected to a monopolar diathermy apparatus (Aspen, Caledonia, MI) on spray mode at 50-W setting, cervical lesion was completely destroyed, evidenced by char formation. Group B included 120 cases planned for 70% TCA painting of the cervix. After cleaning of the ectocervix with sterile 0.9% saline, the cervical lesion was meticulously painted with a small piece of cotton on a tenaculum soaked with 70% TCA. All procedures were done immediately after menstruation. Patients in both groups were instructed to avoid manual contact with the cervix or sexual intercourse for 10 days. They were asked to report any intratreatment or posttreatment discomfort or complaints. After 1 month, the patient was examined by a bivalve vaginal speculum for any evidence of persistence of cervical lesions, incomplete healing, and infection. If there was persistence of cervical lesion, follow-up examination was made after another 1 month and managed according to the management protocol of treating such patients at our institution.
Outcomes
The primary outcome measure was the frequency of healed cervical lesions defined as complete disappearance cytological and colposcopic findings of the lesions after 1 month. Secondary outcomes included relief of symptoms and complication rate, patient satisfaction, and tolerability of the procedure.
Statistical Analysis
Statistical analysis was done using SPSS 17.0 statistical software packages (SPSS, Inc., Chicago, IL). Data were presented using descriptive statistics in the form of frequencies and percentages for qualitative variables, and ranges, means and SDs, medians and quartiles for quantitative variables in box plots. The comparability of baseline characteristics according to outcome was ascertained by Student t test (unpaired t test) for continuous variables and Mann-Whitney U test when appropriate and χ2 test for categorical variables. To evaluate the univariate relation between variables, Pearson correlation coefficient was calculated. Values were considered significant if p ≤ .05.
J Low Genit Tract Dis. 2013;17(3):248-254. © 2013 Lippincott Williams & Wilkins
