Endometrial ablation versus hysterectomy: STOP-DUB

Abstract

Dysfunctional uterine bleeding (DUB) is a common clinical condition that frequently leads to hysterectomy. Endometrial ablation --a "minimally invasive" surgical technique that removes or destroys the endometrial lining of the uterus -- is a conservative alternative to hysterectomy for DUB. While endometrial ablation has lower immediate costs and shorter recovery than hysterectomy, symptoms are not always resolved. Available data from studies with admittedly incomplete follow-up suggest that up to one quarter of patients treated with endometrial ablation require repeat ablation or subsequent hysterectomy to stop DUB. This suggests that the short-term advantages of endometrial ablation may be offset by possible longer-term disadvantages. The Surgical Treatments Outcomes Project for Dysfunctional Uterine Bleeding (STOP-DUB) is a randomized trial designed to compare endometrial ablation against hysterectomy. The primary outcomes address issues of importance to women, such as quality of life and resolution of symptoms that led to surgery. Other outcomes include subsequent surgery and cost-effectiveness of the procedures. The study's target enrollment is 800 women--400 in each treatment group -- from 20 clinical centers throughout the US. The women will be followed for 2 years after surgery. Part of the STOP-DUB is a parallel observational study that involves women who do not choose surgery or who are not eligible for the randomized trial but could become eligible with time. It is anticipated that the result of this research will provide important information to women and their health care professionals as they consider the relative merits of surgical treatments for DUB.