Functional Outcomes of Surgical Management of Deep Endometriosis Infiltrating the Rectum (ENDORE)

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)

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).

Study Overview

• Status: Completed
• Conditions: Endometriosis, Rectum
• Intervention / Treatment: Procedure: Rectal/colorectal segmental resection; Procedure: Rectal nodule excision

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France, 59000
    • Service de Gynécologie et Obstétrique, CHU Jean de Flandre
  • Paris, France, 75020
    • Service de Gynécologique-Obstétricale et Reproduction Humaine, Hôpital Tenon, Université Pierre et Marie Curie Paris 6
  • Rouen, France, 76031
    • Rouen University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Rectal/colorectal segmental resection	Procedure: Rectal/colorectal segmental resection; Resection of the rectum +/- sigmoid colon involved by the deep infiltrating endometriosis; Other Names: Anterior rectal resection
Active Comparator: Rectal nodule excision	Procedure: Rectal nodule excision; Either full thickness excision or rectal shaving; Other Names: Conservative sergery of the rectum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of women experiencing a postoperative digestive or urinary dysfunction	At least one of following symptoms: major constipation (< 1 stool/5 days) associated with defecation pain;; increase of the stool frequency ( >=3 stools/day);; anal incontinence;; de novo postoperative dysuria confirmed by urodynamic work up;; bladder atony requiring daily catheterization.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of women experiencing postoperative pain related to endometriosis	Percentage of women presenting with dysmenorrhea, dyspareunia, chronic pelvic pain	24 months
Percentage of women experiencing a postoperative digestive or urinary dysfunction	At least one of following symptoms: major constipation (< 1 stool/5 days) associated with defecation pain;; increase of the stool frequency ( >=3 stools/day);; anal incontinence;; de novo postoperative dysuria confirmed by urodynamic work up;; bladder atony requiring daily catheterization.	12 months
Biberoglu & Behrman score	Evaluation of endometriosis related pain using the above mentioned scale	24 months
SF-36 quality of life scale		24 months
The Gastrointestinal Quality of Life Index (GIQLI)		24 months
The Knowles-Eccersley-Scott-Symptom Questionnaire (KESS)		24 months
Wexner questionnaire related to anal incontinence		24 months
percentage of women requiring endoscopic dilatation due to the stenosis of the colorectal anastomosis		24 months
Percentage of women presenting postoperative rectal fistulae or leakage of rectal suture or colorectal anastomosis		24 months

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Investigators: Principal Investigator: Horace Roman, MD PhD, Rouen University Hospital, France

Publications and helpful links

General Publications

• Roman H, Tuech JJ, Huet E, Bridoux V, Khalil H, Hennetier C, Bubenheim M, Branduse LA. Excision versus colorectal resection in deep endometriosis infiltrating the rectum: 5-year follow-up of patients enrolled in a randomized controlled trial. Hum Reprod. 2019 Dec 1;34(12):2362-2371. doi: 10.1093/humrep/dez217.
• Roman H, Chanavaz-Lacheray I, Ballester M, Bendifallah S, Touleimat S, Tuech JJ, Farella M, Merlot B. High postoperative fertility rate following surgical management of colorectal endometriosis. Hum Reprod. 2018 Sep 1;33(9):1669-1676. doi: 10.1093/humrep/dey146.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2011
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 22, 2015

Study Registration Dates

• First Submitted: January 31, 2011
• First Submitted That Met QC Criteria: February 7, 2011
• First Posted (Estimated): February 8, 2011

Study Record Updates

• Last Update Posted (Estimated): October 6, 2025
• Last Update Submitted That Met QC Criteria: October 2, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Constipation; Deep infiltrating endometriosis; Functional outcomes; Colorectal resection; Rectal shaving; Rectal endometriosis; Nodule excision
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Signs and Symptoms, Digestive; Genital Diseases, Female; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Constipation; Endometriosis; Therapeutics; Drug Administration Routes; Drug Therapy; Administration, Mucosal; Administration, Topical; Administration, Rectal
• Other Study ID Numbers: 2009/069/HP