Benefit of Hemostatic Sealant in Preservation of Ovarian Reserve

NCT05037552 | Unknown

• 1 other identifier: RECHMPL20_0664
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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

Keywords

Ovarien cyst; Bipolar; Ovarian reserve; Hemostatic agent; Coelioscopy

Outcome Measures

Primary Outcomes (3)

• Serum anti-Mullerian hormone (AMH) level preoperative

  A biological assessment with determination of the serum AMH level will be carried out for each patient during the preoperative consultation.

  Between 2 and 17 days before cystectomy

• Serum anti-Mullerian hormone (AMH) level at 3 months

  A biological assessment with determination of the serum AMH level will be carried out for each patient, 3 months postoperatively.

  3 months after the cystectomy

• Serum anti-Mullerian hormone (AMH) level at 6 months

  A biological assessment with determination of the serum AMH level will be carried out for each patient, 6 months postoperatively.

  6 months after the cystectomy

Secondary Outcomes (5)

• Time to achieve hemostasis

  From the end of the cystectomy to the end of hemostasis (up to 1 hour)

• Use of additional hemostatsis technique

  From the end of the cystectomy to the end of hemostasis, during surgery

• Blood loss

  From the start of the surgery to the end of hemostasis

• Intraoperative adverse effects

  From the end of the cystectomy to the end of hemostasis

• Revision surgery for bleeding at the operative site

  From the end of the cystectomy to the end of hemostasis

Study Arms (2)

BIPOLAR FORCEPS

ACTIVE COMPARATOR

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

Procedure: Bipolar coagulation

FLOSEAL

EXPERIMENTAL

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.

Procedure: Coagulation by FLOSEAL haemostatic agent

Interventions

Bipolar coagulation 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.

BIPOLAR FORCEPS

Coagulation by FLOSEAL haemostatic agent 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.

FLOSEAL

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Post-menopausal status
• Any suspicious finding of malignant ovarian disease
• Change of contraception method leading to AMH variation
• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (2)

CHU de Montpellier

Montpellier, 34295, France

Location

CHU de Nîmes

Nîmes, 30029, France

Location

Related Links

• FLOSEAL user guide

Study Officials

• Martha DURAES, MD

  Montpellier University Hospital

  STUDY DIRECTOR

Central Study Contacts

Martha DURAES, MD

CONTACT

+334 67 33 65 32; m-duraes@chu-montpellier.fr

Amélie DENOUEL, CRA

CONTACT

+334 67 33 55 72; a-denouel@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: September 8, 2021
• Study Start: September 30, 2023
• Primary Completion: January 30, 2025
• Study Completion: September 30, 2025
• Last Updated: March 13, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)