Endometriosis, Rectum
Conditions
Keywords
Deep infiltrating endometriosis, Rectal endometriosis, Colorectal resection, Nodule excision, Rectal shaving, Functional outcomes, Constipation
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.
Interventions
PROCEDURERectal/colorectal segmental resection
Resection of the rectum +/- sigmoid colon involved by the deep infiltrating endometriosis
PROCEDURERectal nodule excision
Either full thickness excision or rectal shaving
Sponsors
University Hospital, Rouen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 | — |
| Percentage of women experiencing postoperative pain related to endometriosis | 24 months | Percentage of women presenting with dysmenorrhea, dyspareunia, chronic pelvic pain |
| 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 | — |
| The Knowles-Eccersley-Scott-Symptom Questionnaire (KESS) | 24 months | — |
Countries
France
Outcome results
None listed