MEdical Versus SUrgical Treatments of Rectal Endometriosis

Endometriosis Clinical Trial

— MESURE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01973816
• Other study ID #: 2013/001/HP
• Status: Recruiting
• Phase: Phase 3
• First received: October 25, 2013
• Last updated: June 13, 2017
• Start date: November 2014
• Est. completion date: November 2019

Study information

• Verified date: June 2017
• Source: University Hospital, Rouen
• Contact: Horace Roman, MD PhD
• Phone: +33232888745
• Email: horace.roman[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: November 2019
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis

Intervention

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
• Estradiol 0.5% percutaneous gel; Cyproterone acetate 50 mg oral
Daily intake during 24 months

Locations

Country	Name	City	State
France	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	Service de Gynécologie-Obstétrique AP-HP Hôpital du KREMLIN BICETRE	Kremlin Bicetre
France	Hôpital du CHESNAY	Le Chesnay
France	Clinique Gynécologique CHRU de LILLE	Lille
France	Service de Gynécologie-Obstétrique CHU de NIMES	Nimes
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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assessment of digestive function	The Knowles-Eccersley-Scott-Symptom Questionnaire (KESS score), the Gastrointestinal Quality of Life Index (GIQLI), Wexner score of anal continence, Bristol stools score.	24 months
Primary	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	Unfavorable digestive functional outcome	Presence of severe constipation (<1 stool/5D), increased frequency of daily bowel movements (>=3 stools/D), anal incontinence, postoperative dysuria	24 months