MESURE: MEdical Versus SUrgical Treatments of Rectal Endometriosis

Sponsor

University Hospital, Rouen (Other)

Overall Status

Unknown status

CT.gov ID

NCT01973816

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

7.1

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endometriosis	Drug: Triptoreline 11.25 i.v.; Estradiol 0.5% percutaneous gel; Procedure: rectal shaving; rectal disc excision; colorectal resection Drug: Cyproterone acetate 50 mg; estradiol 0.5% percutaneous Drug: Estradiol 0.5% percutaneous gel; Cyproterone acetate 50 mg oral	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

78 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2014

Anticipated Primary Completion Date :

Mar 1, 2018

Anticipated Study Completion Date :

Nov 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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 Drug: Cyproterone acetate 50 mg; estradiol 0.5% percutaneous Daily intake for 18 months
Active Comparator: 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.	Procedure: rectal shaving; rectal disc excision; colorectal resection Drug: Estradiol 0.5% percutaneous gel; Cyproterone acetate 50 mg oral Daily intake during 24 months

Arm

Intervention/Treatment

Experimental: 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.

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

Drug: Cyproterone acetate 50 mg; estradiol 0.5% percutaneous

Daily intake for 18 months

Active Comparator: 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.

Procedure: rectal shaving; rectal disc excision; colorectal resection

Drug: Estradiol 0.5% percutaneous gel; Cyproterone acetate 50 mg oral

Daily intake during 24 months

Outcome Measures

Primary Outcome Measures

Postoperative digestive function [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 Outcome Measures

Unfavorable digestive functional outcome [24 months]
Presence of severe constipation (<1 stool/5D), increased frequency of daily bowel movements (>=3 stools/D), anal incontinence, postoperative dysuria

Other Outcome Measures

Assessment of digestive function [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	CHU d'AMIENS	Amiens	France	80054
2	Service de Gynécologie, Obstétrique et Médecine de la Reproduction CHU de CLERMONT-FERRAND Hôpital ESTAING 1 place Lucie Aubrac	Clermont-ferrand	France	63000
3	CHU de DIJON	Dijon	France	21079
4	Service de Gynécologie-Obstétrique AP-HP Hôpital du KREMLIN BICETRE	Kremlin Bicetre	France	94270
5	Hôpital du CHESNAY	Le Chesnay	France	78157
6	Clinique Gynécologique CHRU de LILLE	Lille	France	59037
7	Service de Gynécologie-Obstétrique CHU de NIMES	Nimes	France	39900
8	Hôpital de TENON	Paris	France	75020
9	Chi Poissy-St Germain En Laye Poissy	Poissy	France	78103
10	Clinique Gynécologique et Obstétricale	Rouen	France	76031
11	CHU de STRASBOURG STRASBOURG	Strasbourg	France	67000