Study:
Laparoscopic Rectal Prolapse Surgery Study. An International, Double Cohort Study to Determine the Optimal Treatment for Rectal Prolapse.
Rationale:
n/a
Purpose:
Background:
Rectal prolapse (RP) is the descent of the upper rectum and is a common problem in the
western world. Surgery is the only definite treatment and is preferably performed minimally
invasive. High-level prospective 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 golden standard.
Objective:
To determine the optimal minimally invasive surgical treatment for patients with RP.
Design:
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. Preoperative
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 & secondary outcomes:
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.
Time frame:
Study and inclusion start will be on January the 1st, 2011 and will take approximately 18-24
months. Therefore, total study duration will be 42-48 months.
Study Status: Recruiting
Recruiting:
Jorge Canedo 954-659-5861 canedoj@ccf.org
| Condition |
Intervention |
Phase |
Rectal Prolapse
Procidentia |
Procedure: Laparoscopic Resection Rectopexy
Procedure: Laparoscopic Ventral Rectopexy |
N/A |
Verified by
Cleveland Clinic Florida
May, 2012
Sponsored by: Cleveland Clinic Florida
Information provided by: Cleveland Clinic Florida
ClinicalTrials.gov identifier: NCT01595412
Study Type: Interventional
Study Design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Cleveland Clinic Floria
Weston, Florida 33331
United States
Steven D Wexner, MD., Principal Investigator