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
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Rectal/colorectal segmental resection | Resection of the rectum +/- sigmoid colon involved by the deep infiltrating endometriosis |
| PROCEDURE | Rectal nodule excision | Either 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.