Benefit of Hemostatic Sealant in Preservation of Ovarian Reserve

NCT ID: NCT05037552

Last Updated: 2023-03-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-30
• Study Completion Date: 2025-09-30

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

BIPOLAR FORCEPS

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

Group Type: ACTIVE_COMPARATOR

Bipolar coagulation

Intervention Type: PROCEDURE

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.

FLOSEAL

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.

Group Type: EXPERIMENTAL

Coagulation by FLOSEAL haemostatic agent

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role: collaborator

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martha DURAES, MD

Role: STUDY_DIRECTOR

Montpellier University Hospital

Locations

CHU de Montpellier

Montpellier, , France

CHU de Nîmes

Nîmes, , France

Countries

France

Central Contacts

Martha DURAES, MD

Role: CONTACT

m-duraes@chu-montpellier.fr

+334 67 33 65 32

Amélie DENOUEL, CRA

Role: CONTACT

a-denouel@chu-montpellier.fr

+334 67 33 55 72

Facility Contacts

Martha DURAES, MD

Role: primary

m-duraes@chu-montpellier.fr

+334.67.33.65.32

Renaud DE TAYRAC, MD PhD

Role: primary

renaud.detayrac@chu-nimes.fr

Related Links

http://www.baxter.ca/sites/g/files/ebysai1431/files/2018-11/Floseal_EN_FR.pdf

FLOSEAL user guide

Other Identifiers

RECHMPL20_0664

Identifier Type: -

Identifier Source: org_study_id