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NCT Number: NCT01973816

MEdical Versus SUrgical Treatments of Rectal Endometriosis

The purpose of this study is to determine whether, in women with deep endometriosis involving the rectum and not intending to get pregnant, continuous hormonal treatment would be followed by better digestive functional outcomes than curative rectal surgery. Are included women from 35 to 50 years presenting with deep endometriosis infiltrating at least the muscular layer of the rectum and not having pregnancy intention.

The main outcome concerns the quality of digestive function 24 after the onset of the treatment, assessed using a composite variable: patient considering that digestive function is normal AND the Knowles-Eccersley-Scott-Symptom Questionnaire (KESS score) <7 AND the Gastrointestinal Quality of Life Index (GIQLI) score >100.

Secondary outcomes are: presence of severe constipation, increased frequency of daily bowel movements, anal incontinence, postoperative dysuria, Biberoglou & Behrman score, quality of life SF36 score, KESS score, GIQLI, Wexner score of anal continence, Bristol stools score, the rate of postoperative complications, medical treatment adverse outcomes, the rate of additional endoscopic and surgical procedures.

The randomization is central, once the physician asses the diagnosis, explain the study's principle and rece In the arm A, the patients received triptoreline and add back therapy by estradiol during 6 months, followed by daily intake of cyproterone acetate and add back therapy during 18 months.

In the arm B, patients are managed by rectal surgery (depending on the surgeon choice: rectal shaving, rectal disc excision or colorectal resection) followed by the prevention of recurrences by daily intake of cyproterone acetate and add back therapy during 18 months.

The number of subjects required is 78 (39 on each arm). Inclusions period is estimated at 24 months. The length of the follow up is 24 months. The patients have 8 visits in the arm A, and 7 visits in the arm B.

Eleven French tertiary referral centres will enrol patients in the trial.

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

35 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

CHU d'AMIENS, Amiens, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 35-50
  • No menopause
  • Digestive complaints: defecation pain, dyskesia, diarrhea, constipation, rectorrhage
  • Imaging assessment revealing deep endometriosis involving at least the muscular rectal layer
  • No intention to get pregnant during the following 24 months
  • Negative urinary pregnancy test
  • Affiliated to the French Social Security System

Exclusion criteria

  • Pregnant women or during the breastfeeding
  • Pregnancy intention or lack of efficient contraception
  • Unexpected rectal endometriosis intraoperatively revealed
  • Refus of one of treatments planned in the two arms
  • Severe disease requiring surgical treatment in emergency (bowel occlusion, ureteral stenosis or hydronephrosis), severe dyspareunia
  • Contraindications to hormonal treatment or surgery
  • Major thromboembolic factors
  • Antecedents of inflammatory bowel diseases, cancer or colorectal resection
  • Vaginal hemorrhage with undetermined etiology

Treatment and study plan

Triptoreline 11.25 i.v.; Estradiol 0.5% percutaneous gel;

Drug

Triptoreline 11.25 administered for 3 months, two consecutive cures Estradiol administered daily for 6 months

rectal shaving; rectal disc excision; colorectal resection

Procedure

Cyproterone acetate 50 mg; estradiol 0.5% percutaneous

Drug

Daily intake for 18 months

Estradiol 0.5% percutaneous gel; Cyproterone acetate 50 mg oral

Drug

Daily intake during 24 months

Primary outcomes

  1. Postoperative digestive function

    Time frame: 24 months

    Composite variable: patient considering that digestive function is normal AND the Knowles-Eccersley-Scott-Symptom Questionnaire (KESS score) <7 AND the Gastrointestinal Quality of Life Index (GIQLI) score >100.

Secondary outcomes

  1. Unfavorable digestive functional outcome

    Time frame: 24 months

    Presence of severe constipation (<1 stool/5D), increased frequency of daily bowel movements (>=3 stools/D), anal incontinence, postoperative dysuria

Other outcomes

  1. Assessment of digestive function

    Time frame: 24 months

    The Knowles-Eccersley-Scott-Symptom Questionnaire (KESS score), the Gastrointestinal Quality of Life Index (GIQLI), Wexner score of anal continence, Bristol stools score.

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study title

Randomized Trial Comparing Functional Digestive Outcomes Related to Two Types of Management of Rectal Endometriosis: Continuous Hormonal Treatment and Curative Surgery

Acronym: MESURE

Important dates

Study start
2014
Primary completion
2022
Study completion
2022
First posted
Nov 1, 2013
Registry last updated
Jan 22, 2026

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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