Functional Outcomes of Surgical Management of Deep Endometriosis Infiltrating the Rectum

Not Applicable

• Conditions: Endometriosis, Rectum
• Interventions: Procedure: Rectal/colorectal segmental resection; Procedure: Rectal nodule excision

• Registration Number: NCT01291576
• Lead Sponsor: University Hospital, Rouen

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).

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 Timeline

• Study First Submitted: 2011-01-31
• Study First Submitted QC: 2011-02-07
• Study First Posted: 2011-02-08
• Study Start: 2011-03
• Primary Completion: 2013-09
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-13
• Last Update Posted: 2017-06-14
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rectal/colorectal segmental resection	Rectal/colorectal segmental resection	-
Rectal nodule excision	Rectal nodule excision	-

Primary Outcome Measures

Name	Time	Method
Percentage of women experiencing a postoperative digestive or urinary dysfunction	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

Name	Time	Method
Percentage of women experiencing a postoperative digestive or urinary dysfunction	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.
Percentage of women experiencing postoperative pain related to endometriosis	24 months	Percentage of women presenting with dysmenorrhea, dyspareunia, chronic pelvic pain
Biberoglu & Behrman score	24 months	Evaluation of endometriosis related pain using the above mentioned scale
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

Trial Locations

Locations (3)

Service de Gynécologie et Obstétrique, CHU Jean de Flandre; 🇫🇷 Lille, France

Rouen University Hospital; 🇫🇷 Rouen, France

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