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Completed

NCT Number: NCT01291576

Functional Outcomes of Surgical Management of Deep Endometriosis Infiltrating the Rectum

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).

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Key information

Conditions

Endometriosis, Rectum Constipation Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Service de Gynécologie et Obstétrique, CHU Jean de Flandre, Lille, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Rectal/colorectal segmental resection

Procedure

Resection of the rectum +/- sigmoid colon involved by the deep infiltrating endometriosis

Other names: Anterior rectal resection

Rectal nodule excision

Procedure

Either full thickness excision or rectal shaving

Other names: Conservative sergery of the rectum

Primary outcomes

  1. 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.

Secondary outcomes

  1. Percentage of women experiencing postoperative pain related to endometriosis

    Time frame: 24 months

    Percentage of women presenting with dysmenorrhea, dyspareunia, chronic pelvic pain

  2. 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.

  3. Biberoglu & Behrman score

    Time frame: 24 months

    Evaluation of endometriosis related pain using the above mentioned scale

  4. SF-36 quality of life scale

    Time frame: 24 months

  5. The Gastrointestinal Quality of Life Index (GIQLI)

    Time frame: 24 months

  6. The Knowles-Eccersley-Scott-Symptom Questionnaire (KESS)

    Time frame: 24 months

  7. Wexner questionnaire related to anal incontinence

    Time frame: 24 months

  8. percentage of women requiring endoscopic dilatation due to the stenosis of the colorectal anastomosis

    Time frame: 24 months

  9. Percentage of women presenting postoperative rectal fistulae or leakage of rectal suture or colorectal anastomosis

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study 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)

Acronym: ENDORE

Important dates

Study start
2011
Primary completion
2013
Study completion
2015
First posted
Feb 8, 2011
Registry last updated
Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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