Benefit of Hemostatic Sealant in Preservation of Ovarian Reserve
- Conditions
- Benign Ovarian CystCystectomy
- Interventions
- Procedure: Coagulation by FLOSEAL haemostatic agentProcedure: Bipolar coagulation
- Registration Number
- NCT05037552
- Lead Sponsor
- University Hospital, Montpellier
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 100
- Cyst diameter between 3 and 10cm
- Preoperative AMH level >0,5ng/ml
- Understanding and acceptance of the protocol
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description FLOSEAL Coagulation by FLOSEAL haemostatic agent 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. BIPOLAR FORCEPS Bipolar coagulation The bipolar forceps allow electrocoagulation and are part of the standard laparoscopy box, delivered by the sterilization service to the gynecology operating room.
- Primary Outcome Measures
Name Time Method Serum anti-Mullerian hormone (AMH) level at 3 months 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 preoperative 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 6 months 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.
- Secondary Outcome Measures
Name Time Method Revision surgery for bleeding at the operative site 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.
Time to achieve hemostasis 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.
Use of additional hemostatsis technique 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
Blood loss From the start of the surgery to the end of hemostasis Blood loss will be measured in ml throughout the surgery.
Intraoperative adverse effects From the end of the cystectomy to the end of hemostasis Adverse effects related to the coagulation procedure will be collected.
Trial Locations
- Locations (2)
CHU de Montpellier
🇫🇷Montpellier, France
CHU de Nîmes
🇫🇷Nîmes, France