Functional Outcomes of Surgical Management of Deep Endometriosis Infiltrating the Rectum

University Hospital, Rouen60 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Enrollment

Conditions

Endometriosis, Rectum

Interventions

Rectal/colorectal segmental resectionPROCEDURE

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

Rectal nodule excisionPROCEDURE

Either full thickness excision or rectal shaving

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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)

Locations (3)

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, France

Outcomes

Primary Outcomes

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.

Time frame: 24 months

Secondary Outcomes

Percentage of women experiencing postoperative pain related to endometriosis

Percentage of women presenting with dysmenorrhea, dyspareunia, chronic pelvic pain

Time frame: 24 months

Percentage of women experiencing a postoperative digestive or urinary dysfunction

Time frame: 12 months

Biberoglu & Behrman score

Evaluation of endometriosis related pain using the above mentioned scale

Time frame: 24 months

SF-36 quality of life scale

Time frame: 24 months

The Gastrointestinal Quality of Life Index (GIQLI)

Time frame: 24 months

The Knowles-Eccersley-Scott-Symptom Questionnaire (KESS)

Time frame: 24 months

Wexner questionnaire related to anal incontinence

Data from ClinicalTrials.gov

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