Informations générales (source: ClinicalTrials.gov)
Randomized Trial Comparing Functional Digestive Outcomes Related to Two Types of Management of Rectal Endometriosis: Continuous Hormonal Treatment and Curative Surgery (MESURE)
Interventional
Phase 3
University Hospital, Rouen (Voir sur ClinicalTrials)
novembre 2014
novembre 2019
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Bicêtre | Herve Fernandez, MD PhD | Contact (sur clinicalTrials) | |||
| CHI POISSY ST-GERMAIN | Arnaud Fauconnier, MD PhD | Contact (sur clinicalTrials) | |||
| IFSI AP-HP DE L'HÔPITAL TENON | Emile Darai, MD PhD | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Service de Gynécologie, Obstétrique et Médecine de la Reproduction CHU de CLERMONT-FERRAND Hôpital ESTAING 1 place Lucie Aubrac - 63000 - Clermont-ferrand - France | Michel Canis, MD PhD | Contact (sur clinicalTrials) | |||
| Service de Gynécologie-Obstétrique CHU de NIMES - 39900 - Nimes - France | RenaudTayrac de Tayrac, MD PhD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU d'AMIENS - 80054 - Amiens - France | Sophie Sanguin, MD | Contact (sur clinicalTrials) | |||
| CHU de DIJON - 21079 - Dijon - France | Paul Sagot, MD PhD | Contact (sur clinicalTrials) | |||
| CHU de STRASBOURG STRASBOURG - 67000 - Strasbourg - France | Arnaud Wattiez, MD PhD | Contact (sur clinicalTrials) | |||
| Clinique Gynécologique CHRU de LILLE - 59037 - Lille - France | Chrystele Rubod, MCUPH | Contact (sur clinicalTrials) | |||
| Clinique Gynécologique et Obstétricale - 76031 - Rouen - France | Horace Roman, MD PhD | Contact (sur clinicalTrials) | |||
| Hôpital du CHESNAY - 78157 - Le Chesnay - France | Pierre Panel, MD | Contact (sur clinicalTrials) | |||
Critères
Femme
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
- 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
- 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