Clinical trial NCT01291576: Functional Outcomes of Surgical Management of Deep Endometriosis Infiltrating the Rectum
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endometriosis, Rectum
Keywords: Deep infiltrating endometriosis
Rectal endometriosis
Colorectal resection
Nodule excision
Rectal shaving
Functional outcomes
Constipation
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2011-02-08
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: Percentage of women experiencing a postoperative digestive or urinary dysfunction
timeFrame: 24 months
Secondary outcomes:
measure: Percentage of women experiencing postoperative pain related to endometriosis
timeFrame: 24 months
measure: Percentage of women experiencing a postoperative digestive or urinary dysfunction
timeFrame: 12 months
measure: Biberoglu & Behrman score
timeFrame: 24 months
measure: SF-36 quality of life scale
timeFrame: 24 months
measure: The Gastrointestinal Quality of Life Index (GIQLI)
timeFrame: 24 months
measure: The Knowles-Eccersley-Scott-Symptom Questionnaire (KESS)
timeFrame: 24 months
measure: Wexner questionnaire related to anal incontinence
timeFrame: 24 months
measure: percentage of women requiring endoscopic dilatation due to the stenosis of the colorectal anastomosis
timeFrame: 24 months
measure: Percentage of women presenting postoperative rectal fistulae or leakage of rectal suture or colorectal anastomosis
timeFrame: 24 months
Other outcomes:
Locations:
city: Lille
country: France
facility: Service de Gynécologie et Obstétrique, CHU Jean de Flandre
city: Paris
country: France
facility: Service de Gynécologique-Obstétricale et Reproduction Humaine, Hôpital Tenon, Université Pierre et Marie Curie Paris 6
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: Rouen University Hospital, France
name: Horace Roman, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.