NCT05037552

Benefit of Hemostatic Sealant in Preservation of Ovarian Reserve

Additional Benefit of Hemostatic Sealant in Preservation of Ovarian Reserve During Laparoscopic Ovarian Cystectomy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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 or/and 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- Müllerian 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.

Conditions

• Benign Ovarian Cyst
• Cystectomy

Interventions

Type	Name	Description
PROCEDURE	Bipolar coagulation	Cystectomy will be done via laparoendoscopic surgery After identifying the correct plane of cleavage, the stripping technique will be used. The cyst wall will be gently pulled down from the remaining ovary with two pairs of atraumatic forceps. Once the whole cyst wall will be separated from the ovary cortex, bleeding of the remaining ovarian stromal tissue will be controlled by bipolar coagulation. Then, the remnant tissue will be examined using irrigation and coagulated with minimal bipolar power (20-W current) on any sites that are bleeding.
PROCEDURE	Coagulation by FLOSEAL haemostatic agent	Cystectomy will be done via laparoendoscopic surgery After identifying the correct plane of cleavage, the stripping technique will be used. The cyst wall will be gently pulled down from the remaining ovary with two pairs of atraumatic forceps. Once the whole cyst wall will be separated from the ovary cortex, bleeding of the remaining ovarian stromal tissue will be controlled by either hemostatic sealants (FloSeal). Using a laparoscopic applicator, FloSeal will be applied to the surface of bleeding sites under direct vision and the ovarian cortex was gently pressed for 2 min with small gauze.

Timeline

• Start date: 2023-09-30
• Primary completion: 2025-01-30
• Completion: 2025-09-30
• First posted: 2021-09-08
• Last updated: 2023-03-13

Locations

2 sites across 1 country: France