Ignite Creation Date:
2024-05-06 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05801523
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2023-03-23
Brief Title:
Laparoscopic Therapy of Endometrioma Sclerotherapy vs Cystectomy in Patients With Unfinished Reproductive Plans
Sponsor:
Institute for the Care of Mother and Child Prague Czech Republic
Organization:
Institute for the Care of Mother and Child Prague Czech Republic
Study Overview
Official Title:
Laparoscopic Therapy of Endometrioma Sclerotherapy vs Cystectomy in Patients With Unfinished Reproductive Plans
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
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:
None
Brief 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 34 - 612months after surgery AMH Ultrasound complications pregnancy asissted reproduction pain levels visit 5- 24 months after surgery Ultrasound complications pregnancy asissted reproduction pain levels
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 34 - 612months after surgery AMH Ultrasound complications pregnancy asissted reproduction pain levels visit 5- 24 months after surgery Ultrasound complications pregnancy asissted reproduction pain levels
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