Benefit of Hemostatic Sealant in Preservation of Ovarian Reserve

Study Overview
=================
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.

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

Conditions
-----------------
Benign Ovarian Cyst, Cystectomy

Intervention / Treatment
-----------------
* Procedure: Bipolar coagulation
* Procedure: Coagulation by FLOSEAL haemostatic agent


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BIPOLAR FORCEPS<br>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<br>* 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.<br>|
| Experimental: FLOSEAL<br>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<br>* 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.<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ovarien cyst, Bipolar, Ovarian reserve, Hemostatic agent, Coelioscopy