Benign Ovarian CystFLOKIPNCT05037552
Benefit of Hemostatic Sealant in Preservation of Ovarian Reserve
A study testing Bipolar coagulation and Coagulation by FLOSEAL haemostatic agent in people with Benign Ovarian Cyst and Cystectomy, run by University Hospital, Montpellier at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Benign Ovarian Cyst, Cystectomy
- What is being tested?
- Bipolar coagulation and Coagulation by FLOSEAL haemostatic agent
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesFrance
- Study dates
- 30 Sep 2023to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Cyst diameter between 3 and 10cm
- Preoperative AMH level >0,5ng/ml
- Understanding and acceptance of the protocol
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
2 sites in 1 country.
France2 sites
CHU de Montpellier
Montpellier, 34295
Martha DURAES, MD, +334.67.33.65.32, m-duraes@chu-montpellier.fr
Martha DURAES, MD
CHU de Nîmes
Nîmes, 30029
Renaud DE TAYRAC, MD PhD, renaud.detayrac@chu-nimes.fr
Renaud DE TAYRAC, MD PhD
About this study
Official title: 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.
- Conditions
- Benign Ovarian Cyst, Cystectomy
- Being tested
- Bipolar coagulation, Coagulation by FLOSEAL haemostatic agent
- Keywords
- Ovarien cyst, Bipolar, Ovarian reserve, Hemostatic agent, Coelioscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bipolar coagulationProcedure or surgery
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.
Coagulation by FLOSEAL haemostatic agentProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Coagulation by FLOSEAL haemostatic agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6 months after the cystectomy
Secondary outcomes (5)
Time to achieve hemostasis
The time is measured in minutes from the end of the cystectomy to the end of hemostasis.
Measured: 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
Measured: 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.
Measured: From the start of the surgery to the end of hemostasis
Intraoperative adverse effects
Adverse effects related to the coagulation procedure will be collected.
Measured: 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.
Measured: From the end of the cystectomy to the end of hemostasis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2021
- Study start30 Sep 2023 (estimated)
- Primary completion30 Jan 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Ovarian CystStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Sponsor
- Investigators
- Martha DURAES, MD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05037552
- Sponsor's protocol ID
- RECHMPL20_0664
- Acronym
- FLOKIP
- Status last verified
- Mar 2023
- First submitted
- 31 Aug 2021
- Last updated
- 13 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additional Benefit of Hemostatic Sealant in Preservation of Ovarian Reserve During Laparoscopic Ovarian Cystectomy
- ClinicalTrials.gov ID
- NCT05037552
- Acronym / sponsor ID
- FLOKIP / RECHMPL20_0664
- Conditions
- Benign Ovarian Cyst, Cystectomy
- Keywords
- Ovarien cyst, Bipolar, Ovarian reserve, Hemostatic agent, Coelioscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- 30 Sep 2023 (estimated)
- Primary completion
- 30 Jan 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 8 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIPOLAR FORCEPS | Active comparator | Procedure: Bipolar coagulationThe bipolar forceps allow electrocoagulation and are part of the standard laparoscopy box, delivered by the sterilization service to the gynecology operating room. |
| FLOSEAL | Experimental | Procedure: Coagulation by FLOSEAL haemostatic agentFLOSEAL® 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Cyst diameter between 3 and 10cm
- Preoperative AMH level >0,5ng/ml
- Understanding and acceptance of the protocol
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bipolar coagulationCystectomy 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. | Procedure or surgery | BIPOLAR FORCEPS |
| Coagulation by FLOSEAL haemostatic agentCystectomy 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. | Procedure or surgery | FLOSEAL |
Primary outcome
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.
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.
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.
5 secondary outcomes
Time to achieve hemostasis
Time frame: 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
Blood loss
Time frame: 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
Revision surgery for bleeding at the operative site
Time frame: From the end of the cystectomy to the end of hemostasis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
- FLOSEAL user guideLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Benign Ovarian Cyst
Recruiting
Ovarian Reserve After Laparoscopic Cystectomy for Endometriotic and Non-Endometriotic Cysts
Ovarian Cysts, Endometriosis
RecruitingObservational study
Pediatric Ovarian Tissue Banking - Operative Specimens From Females 0-18 Years of Age
Benign Cysts Ovarian, Cystectomy
Not yet recruitingObservational study
Prospective Perioperative Clinical Registry for Women Undergoing Benign Gynecological Surgery
Benign Gynecological Disease, Uterine Fibroids
Recruiting
Save the Ovaries - Surgical Management of Simple Ovarian Cysts in Children and Adolescents
Ovarian Cyst Benign
Active, not recruitingObservational study
Evaluation of Salivary RNAs in the Presence of an Adnexal Mass of Ovarian Origin
Ovarian Cancer, Ovarian Cyst Benign
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martha DURAES, MD study director
University Hospital, Montpellier
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bipolar coagulation and Coagulation by FLOSEAL haemostatic agent in people with Benign Ovarian Cyst and Cystectomy, run by University Hospital, Montpellier at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martha DURAES, MD (+334 67 33 65 32, m-duraes@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum anti-Mullerian hormone (AMH) level preoperative (time frame: Between 2 and 17 days before cystectomy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2023.