NCT01973816

MEdical Versus SUrgical Treatments of Rectal Endometriosis

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: University Hospital, Rouen · Academic / Other
• Sex: Female
• Age: 35 Years – 50 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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
PROCEDURE	rectal shaving; rectal disc excision; colorectal resection
DRUG	Cyproterone acetate 50 mg; estradiol 0.5% percutaneous	Daily intake for 18 months
DRUG	Estradiol 0.5% percutaneous gel; Cyproterone acetate 50 mg oral	Daily intake during 24 months

Timeline

• Start date: 2014-09-09
• Primary completion: 2022-10-11
• Completion: 2022-10-11
• First posted: 2013-11-01
• Last updated: 2026-01-22

Locations

11 sites across 1 country: France