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

• ClinicalTrials.gov Identifier: NCT01291576
• Recruitment Status: Active, not recruiting
• First Posted: February 8, 2011
• Last Update Posted: June 14, 2017
• Sponsor: University Hospital, Rouen
• Information provided by (Responsible Party): University Hospital, Rouen

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Endometriosis, Rectum	Procedure: Rectal/colorectal segmental resection; Procedure: Rectal nodule excision	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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)
• Study Start Date: March 2011
• Actual Primary Completion Date: September 2013
• Estimated Study Completion Date: September 2023

Arms and Interventions

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 Name: Anterior rectal resection
Active Comparator: Rectal nodule excision	Procedure: Rectal nodule excision; Either full thickness excision or rectal shaving; Other Name: Conservative sergery of the rectum

Outcome Measures

Primary Outcome Measures :

1. Percentage of women experiencing a postoperative digestive or urinary dysfunction [ Time Frame: 24 months ]

   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.

Secondary Outcome Measures :

1. Percentage of women experiencing postoperative pain related to endometriosis [ Time Frame: 24 months ]
   Percentage of women presenting with dysmenorrhea, dyspareunia, chronic pelvic pain
2. Percentage of women experiencing a postoperative digestive or urinary dysfunction [ Time Frame: 12 months ]

   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.
3. Biberoglu & Behrman score [ Time Frame: 24 months ]
   Evaluation of endometriosis related pain using the above mentioned scale
4. SF-36 quality of life scale [ Time Frame: 24 months ]
5. The Gastrointestinal Quality of Life Index (GIQLI) [ Time Frame: 24 months ]
6. The Knowles-Eccersley-Scott-Symptom Questionnaire (KESS) [ Time Frame: 24 months ]
7. Wexner questionnaire related to anal incontinence [ Time Frame: 24 months ]
8. percentage of women requiring endoscopic dilatation due to the stenosis of the colorectal anastomosis [ Time Frame: 24 months ]
9. Percentage of women presenting postoperative rectal fistulae or leakage of rectal suture or colorectal anastomosis [ Time Frame: 24 months ]

Eligibility Criteria

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

Criteria

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)

Contacts and Locations

Locations

France

Service de Gynécologie et Obstétrique, CHU Jean de Flandre

Lille, France, 59000

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

Paris, France, 75020

Rouen University Hospital

Rouen, France, 76031

Sponsors and Collaborators

University Hospital, Rouen

Investigators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Erratum in: Hum Reprod. 2020 Mar 27;35(3):736.

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.

• Responsible Party: University Hospital, Rouen
• ClinicalTrials.gov Identifier: NCT01291576
• Other Study ID Numbers: 2009/069/HP
• First Posted: February 8, 2011
• Last Update Posted: June 14, 2017
• Last Verified: June 2017

Keywords provided by University Hospital, Rouen:

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

Additional relevant MeSH terms:

Endometriosis