1. 12493 Treatment Versus Sham Double-Blind Efficacy Study of Robotic HIFU Treatment of Patients With Symptomatic Rectal Endometriosis.
- Author
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Dubernard, G, Canis, MJ, Chapron, C, Collinet, P, Fernandez, H, Estrade, JP, Descamps, P, Capmas, P, Faller, E, Legendre, G, Dennis, T, and Roman, H
- Abstract
To assess the efficacy of HIFU treatment on gynecologic, digestive symptoms and quality of life at 3 months in a double-blind comparative study compared with a sham intervention group. Prospective, multicenter, randomized, controlled, double-blind study. 9 reference endometriosis centers in France. Patients under anesthesia, treated by HIFU or in Sham intervention group. 60 patients randomized in two arms, presenting with rectal endometriosis visible on preoperative imaging, and suffering from acute pelvic pain with a score higher than 3 despite potential hormonal treatment. endorectal HIFU probe operating treatment or in sham setting, in the operating room, under anesthesia. The efficacy of HIFU treatment will be assessed by comparing changes in the level of acute pelvic pain assessed by visual analog scale (VAS), at 3 months, compared with the pre-treatment pain level in the HIFU group versus the sham intervention group. Quality of life and other symptoms related to endometriosis will be assessed as secondary criteria, using questionnaires at 1 and 3 months: gynecological and digestive symptoms (VAS), health status (MOSSF-36), fecal incontinence (WEXNER), constipation (KESS) and overall sexual health (FSFI). Change of lesion volume based on MRI will also be analysed. Today, the sixty patients have been included and the 3 months follow-up is completed for all the patients. Unblinding is planned in June 2024 and the results will be available for the coming AAGL congress (it will be the first presentation in a congress). The results of the safety study had already been presented in last AAGL congress in Nashville during a surgical tutorial session. We feature here a unique design of clinical trial, with a French multicenter randomized double-blind clinical study to assess the efficacy of HIFU treatment compared with a sham intervention group. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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