This trial is active, not recruiting.

Condition endometriosis, rectum
Treatments rectal/colorectal segmental resection, rectal nodule excision
Sponsor University Hospital, Rouen
Start date March 2011
End date September 2013
Trial size 60 participants
Trial identifier NCT01291576, 2009/069/HP


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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
rectal/colorectal segmental resection Anterior rectal resection
Resection of the rectum +/- sigmoid colon involved by the deep infiltrating endometriosis
(Active Comparator)
rectal nodule excision Conservative sergery of the rectum
Either full thickness excision or rectal shaving

Primary Outcomes

Percentage of women experiencing a postoperative digestive or urinary dysfunction
time frame: 24 months

Secondary Outcomes

Percentage of women experiencing postoperative pain related to endometriosis
time frame: 24 months
Percentage of women experiencing a postoperative digestive or urinary dysfunction
time frame: 12 months
Biberoglu & Behrman score
time frame: 24 months
SF-36 quality of life scale
time frame: 24 months
The Gastrointestinal Quality of Life Index (GIQLI)
time frame: 24 months
The Knowles-Eccersley-Scott-Symptom Questionnaire (KESS)
time frame: 24 months
Wexner questionnaire related to anal incontinence
time frame: 24 months
percentage of women requiring endoscopic dilatation due to the stenosis of the colorectal anastomosis
time frame: 24 months
Percentage of women presenting postoperative rectal fistulae or leakage of rectal suture or colorectal anastomosis
time frame: 24 months

Eligibility Criteria

Female participants from 18 years up to 45 years old.

Inclusion Criteria: - female - age >18 and <45 - at least one digestive symptom related to deep endometriosis (pain defecation, either cyclic diarrhea or cyclic constipation, cyclic rectorrhagia) - preoperative work up revealing a deep endometriosis nodule infiltrating the rectum (either muscular or submucosal layer, on less than 50% of rectal circumference) and measuring at least 20 mm - affiliation to the National Social Security System Exclusion Criteria: - pregnant women or likely to be at the moment of the surgery - no preoperative hypothesis of rectal involvement - no intraoperative confirmation of the rectal involvement - advanced rectal endometriosis involving rectal mucosa or more than 50% of the rectal circumference (preoperative assessment using rectal endoscopy or ultrasonography) - women unable to give an informed consent (guardianship or trusteeship)

Additional Information

Official title 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)
Principal investigator Horace Roman, MD PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by University Hospital, Rouen.