Breakdown of simple female genital fistula repair after 7 day versus 14 day postoperative bladder catheterisation: a randomised, controlled, open-label, non-inferiority trial

Publication date: Available online 21 April 2015 Source:The Lancet Author(s): Mark A Barone , Mariana Widmer , Steven Arrowsmith , Joseph Ruminjo , Armando Seuc , Evelyn Landry , Thierno Hamidou Barry , Dantani Danladi , Lucien Djangnikpo , Tagie Gbawuru-Mansaray , Issoufa Harou , Alyona Lewis , Mulu Muleta , Dolorès Nembunzu , Robert Olupot , Ileogben Sunday-Adeoye , Weston Khisa Wakasiaka , Sihem Landoulsi , Alexandre Delamou , Lilian Were , Vera Frajzyngier , Karen Beattie , A Metin Gülmezoglu Background Duration of bladder catheterisation after female genital fistula repair varies widely. We aimed to establish whether 7 day bladder catheterisation was non-inferior to 14 days in terms of incidence of fistula repair breakdown in women with simple fistula. Methods In this randomised, controlled, open-label, non-inferiority trial, we enrolled patients at eight hospitals in the Democratic Republic of the Congo, Ethiopia, Guinea, Kenya, Niger, Nigeria, Sierra Leone, and Uganda. Consenting patients were eligible if they had a simple fistula that was closed after surgery and remained closed 7 days after surgery, understood study procedures and requirements, and agreed to return for follow-up 3 months after surgery. We excluded women if their fistula was not simple or was radiation-induced, associated with cancer, or due to lymphogranuloma venereum; if they were pregnant; or if they had multiple fistula. A research assistant at each site randomly all...
Source: The Lancet - Category: Journals (General) Source Type: research