Impact of ethanol sclerotherapy on pelvic pain and quality of life in patients with endometriomas (ESCOMA study): protocol for a randomised clinical trial.

Abstract

Introduction: Endometriosis is a chronic gynecological disease associated with pelvic pain, infertility, and reduced quality of life. Ovarian endometrioma is its most common manifestation. Although laparoscopic cystectomy is widely used, concerns regarding ovarian reserve have led to increasing interest in conservative approaches. Ultrasound-guided ethanol sclerotherapy (EST) has emerged as a minimally invasive alternative with potential benefits for symptom control and reproductive outcomes. The ESCOMA trial aims to evaluate the impact of EST compared with expectant management on quality of life in women with ovarian endometriomas.

Methods and analysis: ESCOMA is a prospective, multicentre, randomised controlled trial comparing ultrasound-guided ethanol sclerotherapy with expectant management. A total of 288 women with ovarian endometriomas will be randomised in a 1:1 ratio. The primary outcome is change in quality of life at 6 months, assessed using the Endometriosis Health Profile-5 (EHP-5). Secondary outcomes include pain reduction, changes in pain-related biomarkers, ovarian reserve markers, cyst size reduction, reproductive outcomes, adverse events and complications, diagnostic accuracy, and healthcare costs. Analyses will be performed according to both intention-to-treat and per-protocol principles.

Ethics and dissemination: The study was approved by the Clinical Research Ethics Committee of Hospital Universitari de Bellvitge (PR070/25). Written informed consent will be obtained from all participants.

Clinical trial registration: ClinicalTrials.gov, identifier NCT06955221.