MEdical Versus SUrgical Treatments of Rectal Endometriosis

NCT ID: NCT01973816

Last Updated: 2026-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-09
• Study Completion Date: 2022-10-11

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT

Study Groups

Medical treatment

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

Cyproterone acetate 50 mg; estradiol 0.5% percutaneous

Intervention Type: DRUG

Daily intake for 18 months

Surgical

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.

Group Type: ACTIVE_COMPARATOR

rectal shaving; rectal disc excision; colorectal resection

Intervention Type: PROCEDURE

Estradiol 0.5% percutaneous gel; Cyproterone acetate 50 mg oral

Intervention Type: DRUG

Daily intake during 24 months

Interventions

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

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

Intervention Type: DRUG

rectal shaving; rectal disc excision; colorectal resection

Intervention Type: PROCEDURE

Cyproterone acetate 50 mg; estradiol 0.5% percutaneous

Daily intake for 18 months

Intervention Type: DRUG

Estradiol 0.5% percutaneous gel; Cyproterone acetate 50 mg oral

Daily intake during 24 months

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Rouen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU d'AMIENS

Amiens, , France

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

Clermont-Ferrand, , France

CHU de DIJON

Dijon, , France

Hôpital du CHESNAY

Le Chesnay, , France

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

Le Kremlin-Bicêtre, , France

Clinique Gynécologique CHRU de LILLE

Lille, , France

Service de Gynécologie-Obstétrique CHU de NIMES

Nîmes, , France

Hôpital de TENON

Paris, , France

Chi Poissy-St Germain En Laye Poissy

Poissy, , France

Clinique Gynécologique et Obstétricale

Rouen, , France

CHU de STRASBOURG STRASBOURG

Strasbourg, , France

Countries

France

Other Identifiers

2013/001/HP

Identifier Type: -

Identifier Source: org_study_id