Clinical trial NCT01973816: MEdical Versus SUrgical Treatments of Rectal Endometriosis
Official title: Randomized Trial Comparing Functional Digestive Outcomes Related to Two Types of Management of Rectal Endometriosis: Continuous Hormonal Treatment and Curative Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Endometriosis
Keywords: deep endometriosis;
rectal endometriosis;
rectal shaving;
colorectal resection;
bowel endometriosis
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2013-11-01
Enrollment: 78
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Postoperative digestive function
timeFrame: 24 months
Secondary outcomes:
measure: Unfavorable digestive functional outcome
timeFrame: 24 months
Other outcomes:
measure: Assessment of digestive function
timeFrame: 24 months
Locations:
city: Amiens
country: France
facility: CHU d'AMIENS
city: Clermont-ferrand
country: France
facility: Service de Gynécologie, Obstétrique et Médecine de la Reproduction CHU de CLERMONT-FERRAND Hôpital ESTAING 1 place Lucie Aubrac
city: Dijon
country: France
facility: CHU de DIJON
city: Kremlin Bicetre
country: France
facility: Service de Gynécologie-Obstétrique AP-HP Hôpital du KREMLIN BICETRE
city: Le Chesnay
country: France
facility: Hôpital du CHESNAY
city: Lille
country: France
facility: Clinique Gynécologique CHRU de LILLE
city: Nimes
country: France
facility: Service de Gynécologie-Obstétrique CHU de NIMES
city: Paris
country: France
facility: Hôpital de TENON
city: Poissy
country: France
facility: Chi Poissy-St Germain En Laye Poissy
city: Rouen
country: France
facility: Clinique Gynécologique et Obstétricale
city: Strasbourg
country: France
facility: CHU de STRASBOURG STRASBOURG
Study officials:
References: