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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medical treatment | Experimental | 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. |
|
| Surgical | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triptoreline 11.25 i.v.; Estradiol 0.5% percutaneous gel; | Drug | Triptoreline 11.25 administered for 3 months, two consecutive cures Estradiol administered daily for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU d'AMIENS | Amiens | 80054 | France | |||
| Service de Gynécologie, Obstétrique et Médecine de la Reproduction CHU de CLERMONT-FERRAND Hôpital ESTAING 1 place Lucie Aubrac |
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| rectal shaving; rectal disc excision; colorectal resection | Procedure |
|
| Cyproterone acetate 50 mg; estradiol 0.5% percutaneous | Drug | Daily intake for 18 months |
|
| Estradiol 0.5% percutaneous gel; Cyproterone acetate 50 mg oral | Drug | Daily intake during 24 months |
|
| Clermont-Ferrand |
| 63000 |
| France |
| CHU de DIJON | Dijon | 21079 | France |
| Hôpital du CHESNAY | Le Chesnay | 78157 | France |
| Service de Gynécologie-Obstétrique AP-HP Hôpital du KREMLIN BICETRE | Le Kremlin-Bicêtre | 94270 | France |
| Clinique Gynécologique CHRU de LILLE | Lille | 59037 | France |
| Service de Gynécologie-Obstétrique CHU de NIMES | Nîmes | 39900 | France |
| Hôpital de TENON | Paris | 75020 | France |
| Chi Poissy-St Germain En Laye Poissy | Poissy | 78103 | France |
| Clinique Gynécologique et Obstétricale | Rouen | 76031 | France |
| CHU de STRASBOURG STRASBOURG | Strasbourg | 67000 | France |
| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D004958 | Estradiol |
| D000279 | Administration, Cutaneous |
| D017373 | Cyproterone Acetate |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D000287 | Administration, Topical |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D003534 | Cyproterone |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013258 | Steroids, Chlorinated |
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