Clinical trial NCT05037552: Benefit of Hemostatic Sealant in Preservation of Ovarian Reserve
Official title: Additional Benefit of Hemostatic Sealant in Preservation of Ovarian Reserve During Laparoscopic Ovarian Cystectomy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Benign Ovarian Cyst
Cystectomy
Keywords: Ovarien cyst
Bipolar
Ovarian reserve
Hemostatic agent
Coelioscopy
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2021-09-08
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: Serum anti-Mullerian hormone (AMH) level preoperative
timeFrame: Between 2 and 17 days before cystectomy
measure: Serum anti-Mullerian hormone (AMH) level at 3 months
timeFrame: 3 months after the cystectomy
measure: Serum anti-Mullerian hormone (AMH) level at 6 months
timeFrame: 6 months after the cystectomy
Secondary outcomes:
measure: Time to achieve hemostasis
timeFrame: From the end of the cystectomy to the end of hemostasis (up to 1 hour)
measure: Use of additional hemostatsis technique
timeFrame: From the end of the cystectomy to the end of hemostasis, during surgery
measure: Blood loss
timeFrame: From the start of the surgery to the end of hemostasis
measure: Intraoperative adverse effects
timeFrame: From the end of the cystectomy to the end of hemostasis
measure: Revision surgery for bleeding at the operative site
timeFrame: From the end of the cystectomy to the end of hemostasis
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU de Montpellier
city: Nîmes
country: France
facility: CHU de Nîmes
Study officials:
affiliation: Montpellier University Hospital
name: Martha DURAES, MD
role: STUDY_DIRECTOR
References: