Functional Outcomes of Surgical Management of Deep Endometriosis Infiltrating the Rectum
- Conditions
- Endometriosis, Rectum
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 60
- 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
- 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
- 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
Service de Gynécologique-Obstétricale et Reproduction Humaine, Hôpital Tenon, Université Pierre et Marie Curie Paris 6
🇫🇷Paris, France
Rouen University Hospital
🇫🇷Rouen, France
Service de Gynécologie et Obstétrique, CHU Jean de Flandre🇫🇷Lille, France