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 acro...
| Authors: | , , , , , , , , , , , , , , , , , , , , , , |
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| Format: | article |
| Publication Date: | 2025 |
| Country: | España |
| Institution: | Conselleria de Salut i Consum del Govern de les Illes Balears |
| Repository: | Docusalut |
| Language: | English |
| OAI Identifier: | oai:docusalut.com:20.500.13003/26532 |
| Online Access: | https://hdl.handle.net/20.500.13003/26532 |
| Access Level: | Open access |
| Keyword: | Adolescent Adult Endometriosis Ethanol Female Humans Laparoscopy Ovarian Diseases Pain Measurement Recurrence Sclerotherapy Spain Treatment Outcome Ultrasonography Young Adult Adolescente Adulto Etanol Femenino Humanos Laparoscopía Enfermedades del Ovario Dimensión del Dolor Recurrencia Escleroterapia España Resultado del Tratamiento Ultrasonografía Adulto Joven Cystectomy Endometrioma Infertility Pain Recurrences Surgery Ultrasound-guided aspiration |
| Summary: | 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. |
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