The Laparoscopic Rectal Prolapse Surgery (LaProS) Study: aprospective international cohort study to determine the optimal surgical treatment for rectalprolapse: TS03

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Aim:Rectalprolapse (RP) is a commonproblem in the western world. Surgery is the only definite treatment and ispreferably performed minimally invasive. High-levelprospective studies on treatment strategies for RP currently are lacking and, thus, no consensus exist regarding the optimal treatment for patients with RP. Furthermore, remarkable transatlantic differences exist, as in Europe, laparoscopic ventral rectopexy (LVR) is regarded the treatment of choice, while in the USA Laparoscopic Resection Rectopexy (LRR) remains the gold standard. The aim of this trial is to determine the optimal minimally invasive surgical treatment for patients with RP.Method:International,prospective, comparative double cohort study. The first cohort will consist of 120 European patients with a RP and will be treated with LVR. Centres in The Netherlands, Belgium and the UK are enlisted for participation. The second cohort will consist of 120 American patients with a RP, treated with LRR. Several US centres are enlisted. Pre-operative work-up consists of radiological imaging and standardised questionnaires. Follow-up (FU) is set on two years. During FU,pre-operative imaging and questionnaires will be repeated. Primary endpoint will be improvement on the Gastro-Intestinal-Quality-of-Life-Index (GIQLI). Secondary endpoints will be generic Quality-of-Life, functional results, morbidity, mortality, recurrences and cost-effectiveness. Inclusion will start on September 1st, 2010 and will take approximately 18-24 months. Therefore, total study duration will be 42-48 months.

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