Functional Outcomes of Surgical Management of Deep Endometriosis Infiltrating the Rectum
NCT ID: NCT01291576
Last Updated: 2025-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2011-03-31
2015-09-22
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
Study Groups
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Rectal/colorectal segmental resection
Rectal/colorectal segmental resection
Resection of the rectum +/- sigmoid colon involved by the deep infiltrating endometriosis
Rectal nodule excision
Rectal nodule excision
Either full thickness excision or rectal shaving
Interventions
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Rectal/colorectal segmental resection
Resection of the rectum +/- sigmoid colon involved by the deep infiltrating endometriosis
Rectal nodule excision
Either full thickness excision or rectal shaving
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
45 Years
FEMALE
No
Sponsors
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University Hospital, Rouen
OTHER
Responsible Party
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Principal Investigators
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Horace Roman, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Rouen University Hospital, France
Locations
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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
Countries
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References
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Roman H, Tuech JJ, Huet E, Bridoux V, Khalil H, Hennetier C, Bubenheim M, Branduse LA. Excision versus colorectal resection in deep endometriosis infiltrating the rectum: 5-year follow-up of patients enrolled in a randomized controlled trial. Hum Reprod. 2019 Dec 1;34(12):2362-2371. doi: 10.1093/humrep/dez217.
Roman H, Chanavaz-Lacheray I, Ballester M, Bendifallah S, Touleimat S, Tuech JJ, Farella M, Merlot B. High postoperative fertility rate following surgical management of colorectal endometriosis. Hum Reprod. 2018 Sep 1;33(9):1669-1676. doi: 10.1093/humrep/dey146.
Other Identifiers
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2009/069/HP
Identifier Type: -
Identifier Source: org_study_id
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