NCT04178876

Comparison of Laparoscopic Endometrioma Stripping Versus Ethanol Sclerotherapy( CLESS)

Comparison of Laparoscopic Endometrioma Stripping Versus Ethanol Sclerotherapy: Impact on Ovarian Reserve.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Catholic University of the Sacred Heart · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to compare two different laparoscopic surgical techniques (endometrioma stripping vs ethanol sclerotherapy) in terms of ovarian reserve (AMH levels), recurrence rate and pain relief.

Detailed description

Patients with pelvic pain (VAS score≥4) and ultrasound diagnosis of endometrioma \> 4cm candidate to surgical removal of endometrioma will be randomized into 2 group. One Group will undergo laparoscopical stripping technique; the other one will undergo laparoscopic aspiration and sclerotherapy using 95% ethanol. The women will be introduced with both operative options and they will be informed about the randomization . After an elaborate explanation about the study they will sign an informed consent form. the following data will be collected prior the operation: age, gravity \& parity, operative history, general medical history, the cyst size, AMH (Anti Mullerian Hormone), symptoms related to endometriosis (through VAS score), fertility history including any fertility treatment in the past and planned pregnancy after the operation. The laparoscopy will take place in Fondazione Policlinico Gemelli IRCSS, Roma. in the study group the cyst content will be aspirated and flushed with normal saline. 95% sterile ethanol will be instilled into the cyst through a Nelathon catheter. Ethanol will be left in the cyst for 15 min then aspirated as completely as possible following normal saline flushing. In the control group we will follow the standard treatment which is cystectomy. The women will be followed at 1 , 3 , 6 and 12 months after the surgery.

Conditions

• Endometrioma

Interventions

Type	Name	Description
PROCEDURE	ethanol sclerotherapy	Endometrioma laparoscopic aspiration and sclerotherapy using 95% ethanol
PROCEDURE	stripping technique	Endometrioma laparoscopic cystectomy

Timeline

• Start date: 2019-09-13
• Primary completion: 2022-11-01
• Completion: 2023-06-01
• First posted: 2019-11-26
• Last updated: 2019-12-04

Locations

1 site across 1 country: Italy