An International Double Cohort Study to Compare Laparoscopic Ventral Rectopexy With Laparoscopic Resection Rectopexy

Stopped early · Not applicable

Conditions studied: Rectal Prolapse, Procidentia

In brief

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.

Key facts

Study ID

NCT01595412

Run by

The Cleveland Clinic

People needed

2

Starts

2010-01-01

Expected to finish

2017-10-01

Last updated by the study team

2017-10-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All patients with an indication for Laparoscopic Resection Rectopexy* for External Rectal Prolapse (Oxford Grade V)

You may not qualify if…

• Under 18 years of age
• Former rectosigmoid resection
• Former rectal prolapse surgery
• Rectosigmoid tumor
• Severe mental retardation
• Pregnant women

Where it is running

• The Florida Hospital — Orlando, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• Cleveland Clinic Floria — Weston, Florida, United States
• Oschner Clinic North Shore — New Orleans, Louisiana, United States
• John Hopkins — Baltimore, Maryland, United States
• Lahey Medical Center — Burlington, Massachusetts, United States

Full record on ClinicalTrials.gov

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