Functional Outcomes of Surgical Management of Deep Endometriosis Infiltrating the Rectum

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Endometriosis, Rectum

Intervention / Treatment
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* Procedure: Rectal/colorectal segmental resection
* Procedure: Rectal nodule excision


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rectal/colorectal segmental resection<br> | Procedure: Rectal/colorectal segmental resection<br>* Resection of the rectum +/- sigmoid colon involved by the deep infiltrating endometriosis<br>* Other names: Anterior rectal resection;|
| Active Comparator: Rectal nodule excision<br> | Procedure: Rectal nodule excision<br>* Either full thickness excision or rectal shaving<br>* Other names: Conservative sergery of the rectum;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of women experiencing postoperative pain related to endometriosis | Percentage of women presenting with dysmenorrhea, dyspareunia, chronic pelvic pain | 24 months | 
| 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 | 
| Biberoglu & Behrman score | Evaluation of endometriosis related pain using the above mentioned scale | 24 months | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deep infiltrating endometriosis, Rectal endometriosis, Colorectal resection, Nodule excision, Rectal shaving, Functional outcomes, Constipation