OBJECTIVES: To assess the potential of expectant management for simple ovarian cysts diagnosed by transabdominal or transvaginal ultrasonography. To compare the results of needle aspiration with those achieved with simple observation. DESIGN: Randomised trial. SETTING:Hospital department of obstetrics and gynaecology. SUBJECTS:278 women with simple cysts randomly allocated tosimple observation (143) or ultrasound guided fine needle aspiration (135) between 1990 and 1994. MAIN OUTCOME MEASURES: Resolution of cyst or development of malignancy. RESULTS: After six months 269 were available for follow up. The rate of resolution was 46% (59/128) with aspiration and 44.6% (63/141) with observation. Only the diameter of the cyst (P < 0.0001) was a significant independent prognostic factor for resolution in a multivariate analysis. Age and treatment had no significant effect. One woman was subsequently found to have borderline malignant changes on histopathological examination. Her cyst was detected by transabdominal ultrasonography. CONCLUSIONS:Expectant management for up to six months does not cause risks for the patients and allows spontaneous resolution in over a third of cases, avoiding the costs and risks of unnecessary surgery. Aspiration does not provide better results than simple observation.
RCT Entities:
OBJECTIVES: To assess the potential of expectant management for simple ovarian cysts diagnosed by transabdominal or transvaginal ultrasonography. To compare the results of needle aspiration with those achieved with simple observation. DESIGN: Randomised trial. SETTING: Hospital department of obstetrics and gynaecology. SUBJECTS: 278 women with simple cysts randomly allocated to simple observation (143) or ultrasound guided fine needle aspiration (135) between 1990 and 1994. MAIN OUTCOME MEASURES: Resolution of cyst or development of malignancy. RESULTS: After six months 269 were available for follow up. The rate of resolution was 46% (59/128) with aspiration and 44.6% (63/141) with observation. Only the diameter of the cyst (P < 0.0001) was a significant independent prognostic factor for resolution in a multivariate analysis. Age and treatment had no significant effect. One woman was subsequently found to have borderline malignant changes on histopathological examination. Her cyst was detected by transabdominal ultrasonography. CONCLUSIONS: Expectant management for up to six months does not cause risks for the patients and allows spontaneous resolution in over a third of cases, avoiding the costs and risks of unnecessary surgery. Aspiration does not provide better results than simple observation.