Ultrasound-Guided Ethanol Sclerotherapy versus Laparoscopic Surgery for Endometriomas: As-Treated Analysis of a Pragmatic Randomized Clinical Trial

Objective: To compare the efficacy of ultrasound-guided alcohol sclerotherapy versus laparoscopic cystectomy for the management of ovarian endometriomas, focusing on complications, recurrence, pain relief, and healthcare costs. Design: Multicentre, randomised clinical trial. Setting: Twenty secondary and tertiary endometriosis referral centres across Spain. Population: A total of 207 women aged 18–40 years with ovarian endometriomas (35–100 mm in diameter) recruited between February2016-June2022. Patients with extraovarian endometriosis or adenomyosis requiring surgical treatment were excluded. Methods: Participants were randomised to either ultrasound-guided aspiration & alcohol sclerotherapy or standard laparoscopic cystectomy. Complications were assessed using the Clavien-Dindo classification. Pain was measured via a visual analogue scale. Recurrence was defined as the reappearance of a cyst at the treated site and analysed using Kaplan–Meier estimates. The study was conducted as a treated cohort of 155 patients (sclerotherapy: n=89; cystectomy: n=66). Direct hospital costs were also analysed. Main Outcome Measures: Complication rate, recurrence rate, pain relief, and direct treatment costs. Results: Both groups had a complication rate of around 15%, with grade III complications occurring in 1.1% of the sclerotherapy group and 4.5% of the surgery group. Recurrence rates were similar (19.1% sclerotherapy vs. 21.2% cystectomy, p=0.84). Pain relief was similar in both groups (87% vs. 81%). The cost of sclerotherapy was significantly lower (€276 vs. €2,348, p<0.001). Conclusions: Ultrasound-guided alcohol sclerotherapy is a safe, cost-effective alternative to laparoscopic cystectomy for the treatment of endometriomas, with comparable recurrence rates and pain relief. Funding: A grant from Carlos III Health Institute (PI16/00801).