Benefit of Hemostatic Sealant in Preservation of Ovarian Reserve (FLOKIP)

University Hospital Center (CHU)

Status: Not yet enrolling

Conditions: Benign Ovarian Cyst; Cystectomy

Treatments: Procedure: Bipolar coagulation; Procedure: Coagulation by FLOSEAL haemostatic agent

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05037552

RECHMPL20_0664

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Cyst diameter between 3 and 10cm
• Preoperative AMH level >0,5ng/ml
• Understanding and acceptance of the protocol

Exclusion criteria

• Post-menopausal status
• Any suspicious finding of malignant ovarian disease
• Change of contraception method leading to AMH variation
• Allergy to bovine products found before inclusion
• Pregnancy
• Patient who has already participated in the protocol
• Person deprived of liberty by judicial or administrative decision
• Person protected by law, under tutorship or curatorship
• Patient participating in another interventional research on the human person in progress
• Refusal of participation after a period of reflection
• Patient not affiliated or beneficiary of a national health insurance system

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

BIPOLAR FORCEPS

Active Comparator group

Description:

The bipolar forceps allow electrocoagulation and are part of the standard laparoscopy box, delivered by the sterilization service to the gynecology operating room.

Treatment:

Procedure: Bipolar coagulation

FLOSEAL

Experimental group

Description:

FLOSEAL® is a hemostatic agent based on gelatin of bovine origin added to thrombin of human origin. It is a recommended medical device in surgical procedures as an adjunct to hemostasis when control of bleeding, arterial jet seepage, ligation or any other conventional method proves impractical or ineffective. During this study, it will be used in 1st intention.

Treatment:

Procedure: Coagulation by FLOSEAL haemostatic agent