Randomized trial of oral misoprostol treatment for cervical ripening before tandem application in cervix cancer.

Abstract

To investigate the efficacy of oral misoprostol administered to facilitate tandem application to the cervix as a part of brachytherapy in patients with cervical cancer. Eighty patients with cervical cancer who had been planned to undergo brachytherapy at Dr. Lütfi Kırdar Kartal Training and Research Hospital were evaluated in a double-blind, prospective, randomized trial. Patients were divided randomly into two groups of 40 patients. The first and second groups received 400 μg of misoprostol orally and placebo, respectively, 3 h before tandem application. The two groups were compared in terms of age, diameter of tumor, parity, age at first intercourse, amount of bleeding and pain at first tandem application, length of endometrial cavity measured by hysterometer, and size of Hegar dilators used for cervical dilatation. Of all cases, 63.6%, 16.3%, 10%, 6.3%, 2.5%, and 1.3% were Stage IIB, IIIB, IIIA, IVA, IIA and IIC, respectively. Mean (±SD) age (range) was 49.3 ± 13.1 (25-83) years and 56.6 ± 13.2 (30-78) years in the study and control groups, respectively (p = 0.015). Age at first intercourse, diameter of tumor, parity, amount of bleeding at first tandem application, and length of endometrial cavity measured by hysterometer were not significantly different between the two groups. Pain score was significantly higher in the control group (p < 0.001). Application was significantly easier in the study group compared with controls (p < 0.001). Average size of initial Hegar dilators used for cervical dilatation was significantly higher in the study group compared with controls (p = 0.017). Administration of misoprostol 400 μg orally for cervical ripening before tandem application facilitates the procedure, increases patient tolerability and comfort, and may decrease complication rates.