OC09.01: Transrectal high‐intensity focused ultrasound for the management of rectosigmoid deep infiltrating endometriosis: results of phase I clinical trial

Endometriosis of the rectosigmoid is associated with painful symptoms. Surgical resection remains the standard. FocalOne is a transrectal (TR) HIFU device. In a preliminary study, we demonstrated the feasibility of TR-HIFU in 20 patients presenting a rectosigmoid involvement. We conducted a prospective French multicentric study including 60 patients with rectal involvement. Patients filled questionnaires on gynecologic and intestinal symptoms, and on quality of life (QOL) (MOS-SF36 score) before and at one, three and six months after treatment. In this safety study, MRI were performed preoperatively, at day one post-treatment to ensure the absence of complications. At 6 months, both sonography and MRI were performed to assess the evolution of the endometrial lesion. The mean volume of the rectal nodule was 3.0 cc. The procedures were performed under general anesthesia for 70% of the patients. The mean duration of the treatment was 35 min. 55 patients discharged at day one. The overall complication rate was 53%. But only 2 patients (3.3%) presented a postoperative type 2 complication of the Clavien classification. No fistula is to be report. On 60 patients at one, 3 and 6 months, we observed a significant improvement of gynecologic, digestive and QOL of patients. On imaging at 6 months, we demonstrated a significant reduction of the volume (-27%). In this safety study, we demonstrated with a limited number of adverse events, a significant improvement of gynecologic, digestive symptoms and QOL of patients. HIFU treatment of rectal endometriosis appears as an interesting minimally invasive alternative to surgery. Please note: The publisher is not responsible for the content or functionality of any supporting information supplied by the authors. Any queries (other than missing content) should be directed to the corresponding author for the article.