Benefit of Hemostatic Sealant in Preservation of Ovarian Reserve

Cystectomy Clinical Trial

— FLOKIP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05037552
• Other study ID #: RECHMPL20_0664
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 30, 2023
• Est. completion date: September 30, 2025

Study information

• Verified date: March 2023
• Source: University Hospital, Montpellier
• Contact: Martha DURAES, MD
• Phone: +334 67 33 65 32
• Email: m-duraes[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 30, 2025
• Est. primary completion date: January 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Benign Ovarian Cyst
• Cystectomy
• Ovarian Cysts

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	CHU de Montpellier	Montpellier
France	CHU de Nîmes	Nîmes

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Baxter Healthcare Corporation

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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)
Secondary	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
Secondary	Blood loss	Blood loss will be measured in ml throughout the surgery.	From the start of the surgery to the end of hemostasis
Secondary	Intraoperative adverse effects	Adverse effects related to the coagulation procedure will be collected.	From the end of the cystectomy to the end of hemostasis
Secondary	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

External Links

•   FLOSEAL user guide