Clinical Trials Directory

Trials / Completed

CompletedNCT01291576

Functional Outcomes of Surgical Management of Deep Endometriosis Infiltrating the Rectum

Randomized Trial Comparing Digestive and Urinary Dysfunction Secondary to 2 Surgical Techniques Used in the Management of Deep Endometriosis Infiltrating the Rectum: Colorectal Resection and Rectal Nodules Excision (ENDORE)

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
University Hospital, Rouen · Academic / Other
Sex
Female
Age
18 Years – 45 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to determine whether performing colorectal resection in deep endometriosis infiltrating the rectum is responsible for a higher rate of postoperative digestive and urinary dysfunction when compared to rectal nodules excision (conservation of the rectum).

Detailed description

The study compare digestive and urinary functional outcomes following surgical management of rectal endometriosis by either colorectal resection or conservative surgery (shaving or full thickness excision of rectal nodules). Patients managed for rectal endometriosis are randomized in two arms, and followed up for 24 months. The assessment of digestive and urinary functions is performed at 6, 12, 18 and 24 months using standardized questionnaires. Postoperative complications and improvement of endometriosis related pain are also recorded.

Conditions

Interventions

TypeNameDescription
PROCEDURERectal/colorectal segmental resectionResection of the rectum +/- sigmoid colon involved by the deep infiltrating endometriosis
PROCEDURERectal nodule excisionEither full thickness excision or rectal shaving

Timeline

Start date
2011-03-01
Primary completion
2013-09-01
Completion
2015-09-22
First posted
2011-02-08
Last updated
2025-10-06

Locations

3 sites across 1 country: France

Source: ClinicalTrials.gov record NCT01291576. Inclusion in this directory is not an endorsement.