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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Benign Ovarian Cyst; Cystectomy
• Intervention / Treatment: Procedure: Bipolar coagulation; Procedure: Coagulation by FLOSEAL haemostatic agent

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Martha DURAES, MD; Phone Number: +334 67 33 65 32; Email: m-duraes@chu-montpellier.fr
• Study Contact Backup: Name: Amélie DENOUEL, CRA; Phone Number: +334 67 33 55 72; Email: a-denouel@chu-montpellier.fr

Study Locations

• France
  • Montpellier, France, 34295
    • CHU de Montpellier
    • Principal Investigator: Martha DURAES, MD
    • Sub-Investigator: Lucie REBEL, MD
    • Sub-Investigator: Emmanuelle VINTEJOUX, MD
    • Contact: Martha DURAES, MD; Phone Number: +334.67.33.65.32; Email: m-duraes@chu-montpellier.fr
    • Sub-Investigator: Gauthier RATHA, MD
    • Sub-Investigator: Clara COMPAN, MD
    • Sub-Investigator: Claire VINCNS, MD
  • Nîmes, France, 30029
    • CHU de Nîmes
    • Contact: Renaud DE TAYRAC, MD PhD; Email: renaud.detayrac@chu-nimes.fr
    • Principal Investigator: Renaud DE TAYRAC, MD PhD
    • Sub-Investigator: Stéphanie HUBERLAND, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to achieve hemostasis	The time is measured in minutes from the end of the cystectomy to the end of hemostasis.	From the end of the cystectomy to the end of hemostasis (up to 1 hour)
Use of additional hemostatsis technique	Another technique can be used to achieve hemostasis: bipolar forceps, suture or second hemostasis agent. The other technique will be specified if it is used	From the end of the cystectomy to the end of hemostasis, during surgery
Blood loss	Blood loss will be measured in ml throughout the surgery.	From the start of the surgery to the end of hemostasis
Intraoperative adverse effects	Adverse effects related to the coagulation procedure will be collected.	From the end of the cystectomy to the end of hemostasis
Revision surgery for bleeding at the operative site	In the event of bleeding at the operative site, revision surgery may be necessary. In this case the information will be collected.	From the end of the cystectomy to the end of hemostasis

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: Baxter Healthcare Corporation
• Investigators: Study Director: Martha DURAES, MD, Montpellier University Hospital

Publications and helpful links

Helpful Links

• FLOSEAL user guide

Study record dates

Study Major Dates

• Study Start (Anticipated): September 30, 2023
• Primary Completion (Anticipated): January 30, 2025
• Study Completion (Anticipated): September 30, 2025

Study Registration Dates

• First Submitted: August 31, 2021
• First Submitted That Met QC Criteria: August 31, 2021
• First Posted (Actual): September 8, 2021

Study Record Updates

• Last Update Posted (Actual): March 13, 2023
• Last Update Submitted That Met QC Criteria: March 10, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Bipolar; Ovarian reserve; Ovarien cyst; Hemostatic agent; Coelioscopy
• Additional Relevant MeSH Terms: Neoplasms; Endocrine System Diseases; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Ovarian Cysts; Coagulants; Hemostatics
• Other Study ID Numbers: RECHMPL20_0664

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No