Randomised Controlled Non-inferiority Trial Comparing Vaginal Ultrasound-guided Ethanol Sclerotherapy and Laparoscopic Cystectomy for the Management of Ovarian Endometriomas

What this Trial Is About

This research aims to compare two treatments for ovarian endometriomas, a condition where tissue similar to the lining of the uterus grows outside it, often causing pain and fertility issues in women of childbearing age. The study focuses on evaluating whether vaginal ultrasound-guided ethanol sclerotherapy is not less effective than the standard laparoscopic cystectomy in reducing pain one year after treatment. Researchers also want to see if sclerotherapy better preserves ovarian reserve and results in fewer complications, less post-operative pain, and higher patient satisfaction. Participants will be randomly assigned to receive either sclerotherapy or laparoscopic cystectomy. Sclerotherapy involves draining the cyst via an endovaginal ultrasound probe, injecting 95% ethanol into the cyst for 10 minutes, and then removing it. The cystectomy is performed through laparoscopy, where small incisions allow surgical removal of the cyst wall. Both procedures aim to treat endometriomas but differ in technique and potential effects on ovarian health. During the study, participants will be assessed before treatment and followed for one year. Pain levels will be measured using a visual analogue scale at baseline, 3 months, and 12 months. Other evaluations include recurrence of cysts via ultrasound or MRI, pregnancy rates, ovarian reserve tests, quality of life questionnaires, and tracking of complications. Patient satisfaction and symptom changes will also be recorded. The total participant number is planned at 64 to ensure reliable comparison of these outcomes.

Non-inferiority Trial Comparing Vaginal Ultrasound-guided Ethanol Sclerotherapy and Laparoscopic Cystectomy for the Management of Ovarian Endometriomas (E-STEP)