NCT05801523

Laparoscopic Therapy of Endometrioma: Sclerotherapy vs Cystectomy in Patients With Unfinished Reproductive Plans

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Institute for the Care of Mother and Child, Prague, Czech Republic · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The aim of this prospective randomized study is to compare laparoscopic sclerotherapy to cystectomy in following: AMH dynamics, endometrioma recurrence, complications, pregnancy rate, assisted reproduction methods success rate, live birth rate

Detailed description

Only patients who sign informed consent will be included. Only patients wishing for future pregnancy will be involved in the study. Expected number of enrolled subjects is 160 ( 80 in each arm) Patients with endometrioma and planned surgery to remove it will be randomized either to laparoscopic sclerotherapy with 96% ethanol or cystectomy. First AMH sample will be taken day before surgery. If other endometriosis lesions (deep or superficial) are present, they may be also resected during this surgery. Ethanol sclerotherapy description: classical laparoscopic approach - small (max1cm) fenestration of endometrioma - aspiration of endometrioma contents- foley catheter insertion- ballon inflation inside of the cyst- instillation with 96% ethanol which is left in the cyst for 10min- aspiration of ethanol and flushing with saline. Cystectomy: classical laparoscopic approach- large fenestration of endometrioma - aspiration of endometrioma contents- indentification of ovary/ endometrioma tissue and plane between the ovarian capsule and cyst wall is developed using a mix of blunt and sharp dissection - if bleeding is present it is stopped by cautious bipolar coagulation visit 1 - surgery time (AMH day before surgery, age, BMI, endometriosis extent, gravidity/ parity, endometriosis residue after surgery, pain levels) visit 2- 3 months after surgery : Ultrasound, complications, pregnancy, asissted reproduction, pain levels visit 3+4 - 6/12months after surgery: AMH, Ultrasound, complications, pregnancy, asissted reproduction, pain levels visit 5- 24 months after surgery: Ultrasound, complications, pregnancy, asissted reproduction, pain levels

Conditions

• Endometrioma
• Endometriosis

Interventions

Type	Name	Description
PROCEDURE	laparoscopic ethanol sclerotherapy	ethanol (96%) sclerapy of endometrioma - endometrioma is filled with ethanol via foley catether, left for 10 min and than aspirated, endometrioma is washed with saline
PROCEDURE	laparoscopic cystectomy of endometrioma	cystectomy of endometrioma - removal of endometrioma from ovary surgically

Timeline

• Start date: 2023-02-01
• Primary completion: 2024-06-01
• Completion: 2025-07-01
• First posted: 2023-04-06
• Last updated: 2024-05-08

Locations

1 site across 1 country: Czechia