Ultrasound-guided ethanol sclerotherapy versus laparoscopic surgery for endometriomas: a randomized clinical trial in a real-world setting

Abstract

PURPOSE: 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. METHODS: We conducted a multicentre, randomized clinical trial across 20 centers in Spain. A total of 167 women aged 18-40 years with ovarian endometriomas (35-100 mm) were recruited between June 2018 and June 2022. Participants were randomized to receive either ultrasound-guided aspiration with ethanol sclerotherapy or standard laparoscopic cystectomy. Complications were graded using the Clavien-Dindo classification. Pain was assessed using a visual analogue scale (VAS) before and six months after treatment. Recurrence was defined as the reappearance of a cystic lesion at the treated site and analyzed using Kaplan-Meier curves and log-rank tests. The primary analysis followed an intention-to-treat approach and included 158 patients (sclerotherapy: n = 84; cystectomy: n = 74). The per-protocol analysis included 92 patients (sclerotherapy: n = 57; cystectomy: n = 37). Direct hospital costs, complication rates, recurrence, and pain relief were compared between groups. RESULTS: Intention-to-treat analyses show that complications were low in both groups (12%), most of which were Grade I-II, although 4.1% were Grade III in the surgery group. The cost of sclerotherapy was significantly lower (?472 vs. ?2128, p < 0.001). In per-protocol analyses, the cyst recurrence or reappearance was similar between the two groups, with rates of 25.7% (9 of 35) in the surgery group and 22.8% (13 of 57) in the sclerotherapy group (p = 0.16). Pain was improved or completely resolved in 49 of 55 cases (89.1%) in the sclerotherapy group and in 21 of 32 cases (65.7%) in the laparoscopic surgery group (p = 0.05). 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. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/search?term=NCT03571776 . Registered May 5, 2018.