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MEdical Versus SUrgical Treatments of Rectal Endometriosis (MESURE)

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ClinicalTrials.gov Identifier: NCT01973816
Recruitment Status : Recruiting
First Posted : November 1, 2013
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 2014
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

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




Primary Outcome Measures :
  1. Postoperative digestive function [ Time Frame: 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 :
  1. Unfavorable digestive functional outcome [ Time Frame: 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:
  1. Assessment of digestive function [ Time Frame: 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.



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Ages Eligible for Study:   35 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01973816


Contacts
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Contact: Horace Roman, MD PhD +33232888745 horace.roman@gmail.com

Locations
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France
CHU d'AMIENS Not yet recruiting
Amiens, France, 80054
Contact: Sophie Sanguin, MD    +333 22 53 36 23    sanguinsophie@aol.com   
Principal Investigator: Sophie Sanguin         
Service de Gynécologie, Obstétrique et Médecine de la Reproduction CHU de CLERMONT-FERRAND Hôpital ESTAING 1 place Lucie Aubrac Not yet recruiting
Clermont-ferrand, France, 63000
Contact: Michel Canis, MD PhD    +334 73 75 01 38    mcanis@chu-clermontferrand.fr   
Sub-Investigator: Nicolas Bourdel, MD         
CHU de DIJON Not yet recruiting
Dijon, France, 21079
Contact: Paul Sagot, MD PhD    +333 80 29 38 52    paul.sagot@chu-dijon.fr   
Principal Investigator: Paul Sagot         
Service de Gynécologie-Obstétrique AP-HP Hôpital du KREMLIN BICETRE Not yet recruiting
Kremlin Bicetre, France, 94270
Contact: Herve Fernandez, MD PhD    +331 45 21 77 01    herve.fernandez@bct.aphp.fr   
Principal Investigator: Herve Fernandez, MDPhD         
Hôpital du CHESNAY Not yet recruiting
Le Chesnay, France, 78157
Contact: Pierre Panel, MD    +331 39 63 97 33    PPANEL@ch-versailles.fr   
Principal Investigator: Pierre Panel         
Clinique Gynécologique CHRU de LILLE Not yet recruiting
Lille, France, 59037
Contact: Chrystele Rubod, MCUPH    +333 20 44 67 57    chrystele.rubod@chu-lille.fr   
Principal Investigator: Chrystele Rubod         
Service de Gynécologie-Obstétrique CHU de NIMES Not yet recruiting
Nimes, France, 39900
Contact: RenaudTayrac de Tayrac, MD PhD    +336 03 26 32 32    renaud.detayrac@chu-nimes.fr   
Principal Investigator: Renaud de Tayrac, MD PhD         
Hôpital de TENON Not yet recruiting
Paris, France, 75020
Contact: Emile Darai, MD PhD       emile.darai@tnn.aphp.fr   
Sub-Investigator: Marcos Bellester         
Chi Poissy-St Germain En Laye Poissy Not yet recruiting
Poissy, France, 78103
Contact: Arnaud Fauconnier, MD PhD    +331 39 27 52 51    afauconnier@chi-poissy-st-germain.fr   
Principal Investigator: Arnaud Fauconnier         
Clinique Gynécologique et Obstétricale Recruiting
Rouen, France, 76031
Contact: Horace Roman, MD PhD    +33232888745    horace.roman@gmail.com   
Principal Investigator: Horace Roman, MD PhD         
CHU de STRASBOURG STRASBOURG Not yet recruiting
Strasbourg, France, 67000
Contact: Arnaud Wattiez, MD PhD    +333 88 12 74 55    arnaud.wattiez@ircad.fr   
Principal Investigator: Arnaud Wattiez         
Sponsors and Collaborators
University Hospital, Rouen

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Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01973816     History of Changes
Other Study ID Numbers: 2013/001/HP
First Posted: November 1, 2013    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017
Keywords provided by University Hospital, Rouen:
deep endometriosis;
rectal endometriosis;
rectal shaving;
colorectal resection;
bowel endometriosis
Additional relevant MeSH terms:
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Endometriosis
Genital Diseases, Female
Cyproterone Acetate
Triptorelin Pamoate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol
Polyestradiol phosphate
Cyproterone
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Androgen Antagonists
Hormone Antagonists
Antineoplastic Agents
Contraceptive Agents, Male
Luteolytic Agents
Antineoplastic Agents, Hormonal