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

NARecruitingINTERVENTIONAL
Enrollment

64

Participants

Timeline

Start Date

November 19, 2024

Primary Completion Date

March 19, 2028

Study Completion Date

March 19, 2028

Conditions
Ovarian Endometrioma
Interventions
PROCEDURE

Vaginal ultrasound-guided ethanol sclerotherapy

Use of an endovaginal ultrasound probe combined with a puncture guide. The technique involves locating the endometriosis cyst, echo-guided drainage via the endovaginal route, sclerotherapy (replacement of 60% of the punctured volume with 95% ethanol left in place for 10 minutes) and then reaspiration of the ethanol.

PROCEDURE

Laparoscopic cystectomy

Conventional laparoscopy, with the laparoscope introduced through a 10mm incision at the umbilicus, and the laparoscopic instruments used through two or three 5mm incisions (suprapubic and right and left fossa iliaca). The surgical technique may vary according to the patient and the surgeon's preferences or habits, but must necessarily include a cystectomy (cyst wall sent for anatomopathology).

Trial Locations (1)

13005

RECRUITING

gynecology department APHM, Marseille

All Listed Sponsors
lead

Assistance Publique Hopitaux De Marseille

OTHER