DUGi

Feasibility of vnotes as an alternative for the surgical management of benign endometriomas in fertile ages: a stage 2 clinical trial

http://dugi.udg.edu/item/http:@@@@hdl.handle.net@@10256@@26749

BACKGROUND: Endometriosis, a chronic inflammatory condition affecting 2% to 10% of people with uterus and ovaries (PWUO), commonly involves endometriomas. It is associated with dysmenorrhoea, dyspareunia, and infertility and recent 2022 ESHRE Guidelines removed the need for laparoscopy in diagnosis, which has led to new surgical approaches for managing endometriomas. Vaginal Natural Orifice Transluminal Endoscopy Surgery (vNOTES), as a novel surgical procedure, offers several benefits, such as shorter operative time, less blood loss, reduced hospitalization, improved cosmetic results, and quicker recovery. However, its application in ovarian endometriosis remains unproven. OBJECTIVES: This study aims to evaluate the efficacy of vNOTES in treating symptomatic benign endometriomas in fertile PWUO, comparing it to laparoscopic surgery. The main objective is to evaluate the complete cyst excision without conversion to laparotomy. Other key outcomes include fertility impact, blood loss, surgery duration, perioperative complications, hospitalization until discharge, surgical site infection, endometrioma recurrences, and psychological outcomes like pain perception, recovery quality, and achieving of basic activities of daily life and labour independence. STUDY DESIGN AND PARTICIPANTS: This multicentric, parallel-group, randomized clinical trial will be led by the Hospital Universitari Doctor Josep Trueta, in Girona. A total of 172 participants, aged 18 to 50 with symptomatic benign endometriomas, will be recruited in a period of 1 year and 2 months. METHODS: Participants will be randomly assigned to either the intervention group (vNOTES) or the control group (laparoscopy). The study will assess surgical conversion rates, psychological impact, fertility outcomes, and surgical results throughout a one-year follow-up to determine if vNOTES is a at least as good as laparoscopic surgery for benign endometrioma treatment

3