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Trial record 1 of 1 for:    NCT01291576
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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
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

Tracking Information
First Submitted Date  ICMJE January 31, 2011
First Posted Date  ICMJE February 8, 2011
Last Update Posted Date June 14, 2017
Study Start Date  ICMJE March 2011
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2011)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2011)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Functional Outcomes of Surgical Management of Deep Endometriosis Infiltrating the Rectum
Official Title  ICMJE 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)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Endometriosis, Rectum
Intervention  ICMJE
  • Procedure: Rectal/colorectal segmental resection
    Resection of the rectum +/- sigmoid colon involved by the deep infiltrating endometriosis
    Other Name: Anterior rectal resection
  • Procedure: Rectal nodule excision
    Either full thickness excision or rectal shaving
    Other Name: Conservative sergery of the rectum
Study Arms  ICMJE
  • Active Comparator: Rectal/colorectal segmental resection
    Intervention: Procedure: Rectal/colorectal segmental resection
  • Active Comparator: Rectal nodule excision
    Intervention: Procedure: Rectal nodule excision
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: February 7, 2011)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2023
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries Belgium
 
Administrative Information
NCT Number  ICMJE NCT01291576
Other Study ID Numbers  ICMJE 2009/069/HP
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Rouen
Study Sponsor  ICMJE University Hospital, Rouen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Horace Roman, MD PhD Rouen University Hospital, France
PRS Account University Hospital, Rouen
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP