Ignite Creation Date:
2024-05-06 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 2:13 PM
Study NCT ID:
NCT05037552
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-03-13
First Post:
2021-08-31
Brief Title:
Benefit of Hemostatic Sealant in Preservation of Ovarian Reserve
Sponsor:
University Hospital Montpellier
Organization:
University Hospital Montpellier
Study Overview
Official Title:
Additional Benefit of Hemostatic Sealant in Preservation of Ovarian Reserve During Laparoscopic Ovarian Cystectomy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-03
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:
FLOKIP
Brief Summary:
Introduction The most common technique used for ovarian cystectomy is the stripping technique After stripping the cyst wall the subsequent bleeding of the ovarian stromal wound is usually controlled by bipolar coagulation orand by suturing However hemostasis achieved with bipolar coagulation could result in damage to the ovarian reserve To avoid damage to healthy ovarian tissue hemostasis using various topical hemostatic agents has been introduced to control post- cystectomy ovarian wound bleeding Among these FloSeal Baxter Healthcare Corporation Deer- field IL USA is a hemostatic sealant composed of a gelatin-based matrix and thrombin solution
Aim The aim of the study is to evaluate the impact of topical hemostatic sealants and bipolar coagulation during laparoscopic ovarian benign cyst resection on ovarian reserve by comparing the rates of decrease in anti- Mullerian hormone AMH
Methods A randomized prospective data collection was made on women aged 18-45 years who planned to have laparoscopic ovarian cystectomy at one of two institutions n 80 Montpellier University Hospital and Nimes University Hospital France Patients were randomly divided into two groups treated with either a topical hemostatic sealant Floseal or bipolar coagulation for hemostasis Preoperative 3-month and 6-month postoperative AMH levels were checked and the rates of decrease of AMH were compared
Aim The aim of the study is to evaluate the impact of topical hemostatic sealants and bipolar coagulation during laparoscopic ovarian benign cyst resection on ovarian reserve by comparing the rates of decrease in anti- Mullerian hormone AMH
Methods A randomized prospective data collection was made on women aged 18-45 years who planned to have laparoscopic ovarian cystectomy at one of two institutions n 80 Montpellier University Hospital and Nimes University Hospital France Patients were randomly divided into two groups treated with either a topical hemostatic sealant Floseal or bipolar coagulation for hemostasis Preoperative 3-month and 6-month postoperative AMH levels were checked and the rates of decrease of AMH were compared
Detailed Description:
None
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