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

March 10, 2023 updated by: University Hospital, Montpellier

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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:
        • Sub-Investigator:
          • Gauthier RATHA, MD
        • Sub-Investigator:
          • Clara COMPAN, MD
        • Sub-Investigator:
          • Claire VINCNS, MD
      • Nîmes, France, 30029
        • CHU de Nîmes
        • Contact:
        • Principal Investigator:
          • Renaud DE TAYRAC, MD PhD
        • Sub-Investigator:
          • Stéphanie HUBERLAND, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Serum anti-Mullerian hormone (AMH) level preoperative
Time Frame: Between 2 and 17 days before cystectomy
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
Time Frame: 3 months after the cystectomy
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
Time Frame: 6 months after the cystectomy
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to achieve hemostasis
Time Frame: From the end of the cystectomy to the end of hemostasis (up to 1 hour)
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
Time Frame: From the end of the cystectomy to the end of hemostasis, during surgery
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
Time Frame: From the start of the surgery to the end of hemostasis
Blood loss will be measured in ml throughout the surgery.
From the start of the surgery to the end of hemostasis
Intraoperative adverse effects
Time Frame: From the end of the cystectomy to the end of hemostasis
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
Time Frame: From the end of the cystectomy to the end of hemostasis
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Montpellier

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Baxter Healthcare Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Martha DURAES, MD, Montpellier University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 30, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 30, 2025

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 31, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 8, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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