Functional Outcomes of Surgical Management of Deep Endometriosis Infiltrating the Rectum (ENDORE)
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ClinicalTrials.gov Identifier: NCT01291576 |
Recruitment Status :
Active, not recruiting
First Posted : February 8, 2011
Last Update Posted : June 14, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Endometriosis, Rectum | Procedure: Rectal/colorectal segmental resection Procedure: Rectal nodule excision | Not Applicable |
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 (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 Start Date : | March 2011 |
Actual Primary Completion Date : | September 2013 |
Estimated Study Completion Date : | September 2023 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Rectal/colorectal segmental resection |
Procedure: Rectal/colorectal segmental resection
Resection of the rectum +/- sigmoid colon involved by the deep infiltrating endometriosis
Other Name: Anterior rectal resection |
Active Comparator: Rectal nodule excision |
Procedure: Rectal nodule excision
Either full thickness excision or rectal shaving
Other Name: Conservative sergery of the rectum |
- Percentage of women experiencing a postoperative digestive or urinary dysfunction [ Time Frame: 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.
- Percentage of women experiencing postoperative pain related to endometriosis [ Time Frame: 24 months ]Percentage of women presenting with dysmenorrhea, dyspareunia, chronic pelvic pain
- Percentage of women experiencing a postoperative digestive or urinary dysfunction [ Time Frame: 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 [ Time Frame: 24 months ]Evaluation of endometriosis related pain using the above mentioned scale
- 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 [ Time Frame: 24 months ]
- percentage of women requiring endoscopic dilatation due to the stenosis of the colorectal anastomosis [ Time Frame: 24 months ]
- Percentage of women presenting postoperative rectal fistulae or leakage of rectal suture or colorectal anastomosis [ Time Frame: 24 months ]

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts 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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01291576
France | |
Service de Gynécologie et Obstétrique, CHU Jean de Flandre | |
Lille, France, 59000 | |
Service de Gynécologique-Obstétricale et Reproduction Humaine, Hôpital Tenon, Université Pierre et Marie Curie Paris 6 | |
Paris, France, 75020 | |
Rouen University Hospital | |
Rouen, France, 76031 |
Principal Investigator: | Horace Roman, MD PhD | Rouen University Hospital, France |
Responsible Party: | University Hospital, Rouen |
ClinicalTrials.gov Identifier: | NCT01291576 |
Other Study ID Numbers: |
2009/069/HP |
First Posted: | February 8, 2011 Key Record Dates |
Last Update Posted: | June 14, 2017 |
Last Verified: | June 2017 |
Deep infiltrating endometriosis Rectal endometriosis Colorectal resection Nodule excision |
Rectal shaving Functional outcomes Constipation |
Endometriosis |