Trial record 1 of 1 for:    NCT01291576
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Functional Outcomes of Surgical Management of Deep Endometriosis Infiltrating the Rectum (ENDORE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01291576
First received: January 31, 2011
Last updated: October 10, 2013
Last verified: October 2013

January 31, 2011
October 10, 2013
March 2011
September 2013   (final data collection date for primary outcome measure)
Percentage of women experiencing a postoperative digestive or urinary dysfunction [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

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.
Same as current
Complete list of historical versions of study NCT01291576 on ClinicalTrials.gov Archive Site
  • Percentage of women experiencing postoperative pain related to endometriosis [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Percentage of women presenting with dysmenorrhea, dyspareunia, chronic pelvic pain
  • Percentage of women experiencing a postoperative digestive or urinary dysfunction [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: No ]
    Evaluation of endometriosis related pain using the above mentioned scale
  • SF-36 quality of life scale [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • The Gastrointestinal Quality of Life Index (GIQLI) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • The Knowles-Eccersley-Scott-Symptom Questionnaire (KESS) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Wexner questionnaire related to anal incontinence [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • percentage of women requiring endoscopic dilatation due to the stenosis of the colorectal anastomosis [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Percentage of women presenting postoperative rectal fistulae or leakage of rectal suture or colorectal anastomosis [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Functional Outcomes of Surgical Management of Deep Endometriosis Infiltrating the Rectum
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)

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).

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Endometriosis, Rectum
  • 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
  • Active Comparator: Rectal/colorectal segmental resection
    Intervention: Procedure: Rectal/colorectal segmental resection
  • Active Comparator: Rectal nodule excision
    Intervention: Procedure: Rectal nodule excision
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
September 2015
September 2013   (final data collection date for primary outcome measure)

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)
Female
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01291576
2009/069/HP
No
University Hospital, Rouen
University Hospital, Rouen
Not Provided
Principal Investigator: Horace Roman, MD PhD Rouen University Hospital, France
University Hospital, Rouen
October 2013

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