A RANDOMIZED CLINICAL-TRIAL OF CRYOTHERAPY, LASER VAPORIZATION, AND LOOP ELECTROSURGICAL EXCISION FOR TREATMENT OF SQUAMOUS INTRAEPITHELIALLESIONS OF THE CERVIX

Objective: To compare cryotherapy, laser vaporization, and loop electr ical excision for treatment of squamous intraepithelial lesions (SILs) . Methods: Women at least 18 years old with biopsy-proven SIL, negativ e pregnancy tests, negative findings on endocervical curettage, satisf actory colposcopy examinations, and congruent Papanicolaou smear and b iopsy results were assigned randomly to treatment after stratification by SIL grade, endocervical gland involvement, and lesion size; they w ere evaluated 1, 4, 8, 12, 16, 20, and 24 months after treatment. Data were analyzed using chi(2) statistics, logistic regression analysis, and the Cox proportional hazards model. Results: Of 498 patients assig ned, 108 were excluded (most because of inadequate follow-up), leaving 390 (139 cryotherapy, 121 laser vaporization, 130 loop excision) for analysis. All were followed 6-37 months (mean 16). There were no stati stically significant differences in complications, persistence (diseas e present less than 6 months after treatment), or recurrence (disease present more than 6 months after treatment). Risk of persistent diseas e was higher among women with large lesions (risk ratio [RR], 18.9; 95 % confidence interval [CI], 3.2, 110.6). Recurrence risk was higher am ong women aged 30 years and older (RR, 2.1; 95% CI, 1.2, 4.3), those w ith human papillomavirus type 16 or 18 (RR, 2.1; 95% CI, 1.1, 4.0), an d those who had had prior treatment (RR, 2.1; 95% CI, 1.1, 3.9). Concl usion: The data support a high success rate with all three modalities. No significant difference in success rates was observed between the t hree treatments in our population. Additional attention and research s hould be directed toward the higher risk patients identified above. (O bstet Gynecol 1998;92:737-44. (C) 1998 by The American College of Obst etricians and Gynecologists.)