Endometriosis Clinical Trial
Official title:
Randomized Trial Comparing Functional Digestive Outcomes Related to Two Types of Management of Rectal Endometriosis: Continuous Hormonal Treatment and Curative Surgery
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.
n/a
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