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MEdical Versus SUrgical Treatments of Rectal Endometriosis

NCT01973816 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2026-01-22

No results posted yet for this study

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

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

Sponsors & Collaborators

  • University Hospital, Rouen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-09
Primary Completion
2022-10-11
Completion
2022-10-11

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01973816 on ClinicalTrials.gov