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Functional Outcomes of Surgical Management of Deep Endometriosis Infiltrating the Rectum (ENDORE)

Primary Purpose

Endometriosis, Rectum

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Rectal/colorectal segmental resection
Rectal nodule excision
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis, Rectum focused on measuring Deep infiltrating endometriosis, Rectal endometriosis, Colorectal resection, Nodule excision, Rectal shaving, Functional outcomes, Constipation

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Service de Gynécologie et Obstétrique, CHU Jean de Flandre
  • Service de Gynécologique-Obstétricale et Reproduction Humaine, Hôpital Tenon, Université Pierre et Marie Curie Paris 6
  • Rouen University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Rectal/colorectal segmental resection

Rectal nodule excision

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percentage of women experiencing postoperative pain related to endometriosis
Percentage of women presenting with dysmenorrhea, dyspareunia, chronic pelvic pain
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.
Biberoglu & Behrman score
Evaluation of endometriosis related pain using the above mentioned scale
SF-36 quality of life scale
The Gastrointestinal Quality of Life Index (GIQLI)
The Knowles-Eccersley-Scott-Symptom Questionnaire (KESS)
Wexner questionnaire related to anal incontinence
percentage of women requiring endoscopic dilatation due to the stenosis of the colorectal anastomosis
Percentage of women presenting postoperative rectal fistulae or leakage of rectal suture or colorectal anastomosis

Full Information

First Posted
January 31, 2011
Last Updated
June 13, 2017
Sponsor
University Hospital, Rouen
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1. Study Identification

Unique Protocol Identification Number
NCT01291576
Brief Title
Functional Outcomes of Surgical Management of Deep Endometriosis Infiltrating the Rectum
Acronym
ENDORE
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 Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis, Rectum
Keywords
Deep infiltrating endometriosis, Rectal endometriosis, Colorectal resection, Nodule excision, Rectal shaving, Functional outcomes, Constipation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rectal/colorectal segmental resection
Arm Type
Active Comparator
Arm Title
Rectal nodule excision
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Rectal/colorectal segmental resection
Other Intervention Name(s)
Anterior rectal resection
Intervention Description
Resection of the rectum +/- sigmoid colon involved by the deep infiltrating endometriosis
Intervention Type
Procedure
Intervention Name(s)
Rectal nodule excision
Other Intervention Name(s)
Conservative sergery of the rectum
Intervention Description
Either full thickness excision or rectal shaving
Primary Outcome Measure Information:
Title
Percentage of women experiencing a postoperative digestive or urinary dysfunction
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Percentage of women experiencing postoperative pain related to endometriosis
Description
Percentage of women presenting with dysmenorrhea, dyspareunia, chronic pelvic pain
Time Frame
24 months
Title
Percentage of women experiencing a postoperative digestive or urinary dysfunction
Description
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.
Time Frame
12 months
Title
Biberoglu & Behrman score
Description
Evaluation of endometriosis related pain using the above mentioned scale
Time Frame
24 months
Title
SF-36 quality of life scale
Time Frame
24 months
Title
The Gastrointestinal Quality of Life Index (GIQLI)
Time Frame
24 months
Title
The Knowles-Eccersley-Scott-Symptom Questionnaire (KESS)
Time Frame
24 months
Title
Wexner questionnaire related to anal incontinence
Time Frame
24 months
Title
percentage of women requiring endoscopic dilatation due to the stenosis of the colorectal anastomosis
Time Frame
24 months
Title
Percentage of women presenting postoperative rectal fistulae or leakage of rectal suture or colorectal anastomosis
Time Frame
24 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Horace Roman, MD PhD
Organizational Affiliation
Rouen University Hospital, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Gynécologie et Obstétrique, CHU Jean de Flandre
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Service de Gynécologique-Obstétricale et Reproduction Humaine, Hôpital Tenon, Université Pierre et Marie Curie Paris 6
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
Rouen University Hospital
City
Rouen
ZIP/Postal Code
76031
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
31820806
Citation
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. Erratum In: Hum Reprod. 2020 Mar 27;35(3):736.
Results Reference
derived
PubMed Identifier
30052994
Citation
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.
Results Reference
derived

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Functional Outcomes of Surgical Management of Deep Endometriosis Infiltrating the Rectum

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