MEdical Versus SUrgical Treatments of Rectal Endometriosis

NCT01973816 | Completed Phase 3

• 1 other identifier: 2013/001/HP
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 11

Brief Summary

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.

Conditions

Endometriosis

Keywords

deep endometriosis;; rectal endometriosis;; rectal shaving;; colorectal resection;; bowel endometriosis

Outcome Measures

Primary Outcomes (1)

• Postoperative digestive function

  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.

  24 months

Secondary Outcomes (1)

• Unfavorable digestive functional outcome

  24 months

Other Outcomes (1)

• Assessment of digestive function

  24 months

Study Arms (2)

Medical treatment

EXPERIMENTAL

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.

Drug: Triptoreline 11.25 i.v.; Estradiol 0.5% percutaneous gel;; Drug: Cyproterone acetate 50 mg; estradiol 0.5% percutaneous

Surgical

ACTIVE COMPARATOR

The 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.

Procedure: rectal shaving; rectal disc excision; colorectal resection; Drug: Estradiol 0.5% percutaneous gel; Cyproterone acetate 50 mg oral

Interventions

rectal shaving; rectal disc excision; colorectal resection PROCEDURE

Surgical

Cyproterone acetate 50 mg; estradiol 0.5% percutaneous DRUG

Daily intake for 18 months

Medical treatment

Estradiol 0.5% percutaneous gel; Cyproterone acetate 50 mg oral DRUG

Daily intake during 24 months

Surgical

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

Medical treatment

Eligibility Criteria

• Age: 35 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (11)

CHU d'AMIENS

Amiens, 80054, France

Location

Service de Gynécologie, Obstétrique et Médecine de la Reproduction CHU de CLERMONT-FERRAND Hôpital ESTAING 1 place Lucie Aubrac

Clermont-Ferrand, 63000, France

Location

CHU de DIJON

Dijon, 21079, France

Location

Hôpital du CHESNAY

Le Chesnay, 78157, France

Location

Service de Gynécologie-Obstétrique AP-HP Hôpital du KREMLIN BICETRE

Le Kremlin-Bicêtre, 94270, France

Location

Clinique Gynécologique CHRU de LILLE

Lille, 59037, France

Location

Service de Gynécologie-Obstétrique CHU de NIMES

Nîmes, 39900, France

Location

Hôpital de TENON

Paris, 75020, France

Location

Chi Poissy-St Germain En Laye Poissy

Poissy, 78103, France

Location

Clinique Gynécologique et Obstétricale

Rouen, 76031, France

Location

CHU de STRASBOURG STRASBOURG

Strasbourg, 67000, France

Location

MeSH Terms

Conditions

Endometriosis

Interventions

Estradiol; Administration, Cutaneous; Cyproterone Acetate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Administration, Topical; Drug Administration Routes; Drug Therapy; Therapeutics; Cyproterone; Pregnadienes; Pregnanes; Steroids, Chlorinated

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2013
• First Posted: November 1, 2013
• Study Start: September 9, 2014
• Primary Completion: October 11, 2022
• Study Completion: October 11, 2022
• Last Updated: January 22, 2026

Record last verified: 2026-01

Locations

FR (11)