Functional Outcomes of Surgical Management of Deep Endometriosis Infiltrating the Rectum

NCT01291576 | Completed

• 1 other identifier: 2009/069/HP
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief 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).

Conditions

Endometriosis, Rectum

Keywords

Deep infiltrating endometriosis; Rectal endometriosis; Colorectal resection; Nodule excision; Rectal shaving; Functional outcomes; Constipation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Percentage of women experiencing postoperative pain related to endometriosis

  24 months

• Percentage of women experiencing a postoperative digestive or urinary dysfunction

  12 months

• Biberoglu & Behrman score

  24 months

• SF-36 quality of life scale

  24 months

• The Gastrointestinal Quality of Life Index (GIQLI)

  24 months

Study Arms (2)

Rectal/colorectal segmental resection

ACTIVE COMPARATOR

Procedure: Rectal/colorectal segmental resection

Rectal nodule excision

ACTIVE COMPARATOR

Procedure: Rectal nodule excision

Interventions

Rectal/colorectal segmental resection PROCEDURE

Resection of the rectum +/- sigmoid colon involved by the deep infiltrating endometriosis

Also known as: Anterior rectal resection

Rectal/colorectal segmental resection

Rectal nodule excision PROCEDURE

Either full thickness excision or rectal shaving

Also known as: Conservative sergery of the rectum

Rectal nodule excision

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (3)

Service de Gynécologie et Obstétrique, CHU Jean de Flandre

Lille, 59000, France

Location

Service de Gynécologique-Obstétricale et Reproduction Humaine, Hôpital Tenon, Université Pierre et Marie Curie Paris 6

Paris, 75020, France

Location

Rouen University Hospital

Rouen, 76031, France

Location

Related Publications (2)

• 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.

  PMID: 31820806 DERIVED

• 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.

  PMID: 30052994 DERIVED

MeSH Terms

Conditions

Endometriosis; Constipation

Interventions

Administration, Rectal

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Administration, Mucosal; Administration, Topical; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Horace Roman, MD PhD

  Rouen University Hospital, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2011
• First Posted: February 8, 2011
• Study Start: March 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 22, 2015
• Last Updated: October 6, 2025

Record last verified: 2025-10

Locations

FR (3)