MEdical Versus SUrgical Treatments of Rectal Endometriosis (MESURE)
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| ClinicalTrials.gov Identifier: NCT01973816 |
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Recruitment Status : Unknown
Verified June 2017 by University Hospital, Rouen.
Recruitment status was: Recruiting
First Posted : November 1, 2013
Last Update Posted : June 14, 2017
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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 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 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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 |
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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.
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Procedure: rectal shaving; rectal disc excision; colorectal resection Drug: Estradiol 0.5% percutaneous gel; Cyproterone acetate 50 mg oral Daily intake during 24 months |
- 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.
- 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
- 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 |
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
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
| Contact: Horace Roman, MD PhD | +33232888745 | horace.roman@gmail.com |
| 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 | |
| Responsible Party: | University Hospital, Rouen |
| ClinicalTrials.gov Identifier: | NCT01973816 |
| 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 |
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deep endometriosis; rectal endometriosis; rectal shaving; colorectal resection; bowel endometriosis |
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Endometriosis Triptorelin Pamoate Cyproterone Acetate 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 |