Ignite Creation Date:
2024-05-06 @ 1:59 PM
Last Modification Date:
2024-10-26 @ 1:23 PM
Study NCT ID:
NCT04178876
Status:
UNKNOWN
Last Update Posted:
2019-12-04
First Post:
2019-11-25
Brief Title:
Comparison of Laparoscopic Endometrioma Stripping Versus Ethanol Sclerotherapy CLESS
Sponsor:
Catholic University of the Sacred Heart
Organization:
Catholic University of the Sacred Heart
Study Overview
Official Title:
Comparison of Laparoscopic Endometrioma Stripping Versus Ethanol Sclerotherapy Impact on Ovarian Reserve
Status:
UNKNOWN
Status Verified Date:
2019-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CLESS
Brief 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 score4 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None