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
  Purpose

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).


Condition Intervention
Endometriosis, Rectum
Procedure: Rectal/colorectal segmental resection
Procedure: Rectal nodule excision

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: March 2011
Estimated Study Completion Date: September 2015
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01291576

Locations
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
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: Horace Roman, MD PhD Rouen University Hospital, France
  More Information

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01291576     History of Changes
Other Study ID Numbers: 2009/069/HP
Study First Received: January 31, 2011
Last Updated: October 10, 2013
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Rouen:
Deep infiltrating endometriosis
Rectal endometriosis
Colorectal resection
Nodule excision
Rectal shaving
Functional outcomes
Constipation

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 31, 2014