Functional Outcomes of Surgical Management of Deep Endometriosis Infiltrating the Rectum

Endometriosis, Rectum Clinical Trial

— ENDORE  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01291576
• Other study ID #: 2009/069/HP
• Status: Active, not recruiting
• Phase: N/A
• First received: January 31, 2011
• Last updated: June 13, 2017
• Start date: March 2011
• Est. completion date: September 2023

Study information

• Verified date: June 2017
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: September 2023
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Endometriosis
• Endometriosis, Rectum

Intervention

Procedure:
• Rectal/colorectal segmental resection
Resection of the rectum +/- sigmoid colon involved by the deep infiltrating endometriosis
• Rectal nodule excision
Either full thickness excision or rectal shaving

Locations

Country	Name	City	State
France	Service de Gynécologie et Obstétrique, CHU Jean de Flandre	Lille
France	Service de Gynécologique-Obstétricale et Reproduction Humaine, Hôpital Tenon, Université Pierre et Marie Curie Paris 6	Paris
France	Rouen University Hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of women experiencing postoperative pain related to endometriosis	Percentage of women presenting with dysmenorrhea, dyspareunia, chronic pelvic pain	24 months
Secondary	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
Secondary	Biberoglu & Behrman score	Evaluation of endometriosis related pain using the above mentioned scale	24 months
Secondary	SF-36 quality of life scale		24 months
Secondary	The Gastrointestinal Quality of Life Index (GIQLI)		24 months
Secondary	The Knowles-Eccersley-Scott-Symptom Questionnaire (KESS)		24 months
Secondary	Wexner questionnaire related to anal incontinence		24 months
Secondary	percentage of women requiring endoscopic dilatation due to the stenosis of the colorectal anastomosis		24 months
Secondary	Percentage of women presenting postoperative rectal fistulae or leakage of rectal suture or colorectal anastomosis		24 months