Comparison of Hemostatic Agent to Suture in Terms of Hemostatic Function and Preservation of Ovarian Function

Study Overview
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Brief Summary
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This study aims to evaluate the efficacy of preservation of ovarian function, hemostasis, and safety of a hemostatic agent versus suturing during laparoscopic ovarian cystectomy for ovarian endometriosis.

Detailed Description
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In women with endometrioma who plan to undergo laparoscopic ovarian cystectomy, surgical technique can influence postoperative ovarian function because of removal of normal ovarian tissue with ovarian cyst and damage to ovarian tissue during bleeding control after stripping of endometrioma. This study is designed to compare hemostatic sealant to suturing in terms of hemostatic function, safety and preservation of ovarian function. Ovarian function of all patients will be evaluated on pre op, post op 12 weeks, post op 48 weeks by measuring AMH and ovarian volume. And Hemostatic function will be evaluated by measuring serum hemoglobin, blood loss during operation, etc.

Official Title
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A Multi-center, Randomized, Investigator-initiated Trial to Evaluate the Efficacy of PRreservation of ovArian Function, Hemostasis, and sAfety of a Hemostatic Agent Versus Suturing During Laparoscopic Ovarian Cystectomy for Endometrioma

Conditions
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Benign Ovarian Cyst

Intervention / Treatment
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* Procedure: Hemostatic agent (EVICEL®) application during laparoscopic ovarian cystectomy
* Procedure: suturing with barbed sutures during laparoscopic ovarian cystectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent. Age: 19-45 year-old women American Society of Anesthesiologists Physical Status classification 1 or 2 Plan of laparoscopic ovarian cystectomy for unilateral or bilateral ovarian endometriosis diagnosed by ultrasonography Regular menstruation every 21-45 days Exclusion Criteria: No 'ovarian' endometriosis Suspicious disease of ovarian malignancy Age: 18 and younger, 46 and older Pregnancy or breastfeeding. Lower than 0.05 ng/ml of serum Anti-mullerian hormone level Hormonal therapy within recent 3 months Considered as inappropriate by the researcher's judgment.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hemostatic agent group<br>During laparoscopic ovarian cystectomy, bleeding will be controlled by using a hemostatic agent (EVICEL® Fibrin Sealant, Ethicon, USA), which consist of thrombin and coagulating proteins, mainly fibrinogen and fibronectin. If hemostasis is not fulfilled enough by using it, a additional intervention such as electrocoagulation with bipolar forceps and barbed suture is required to stop bleeding. | Procedure: Hemostatic agent (EVICEL®) application during laparoscopic ovarian cystectomy<br>* During laparoscopic ovarian cystectomy, bleeding will be controlled by using a hemostatic agent (EVICEL®)<br>|
| Active Comparator: Suturing group<br>During operation, barbed suture will be applied to the inner surface of ovarian parenchyme where ovarian endometriosis was attached. In this group, if bleeding is continued after suturing, additional electrocoagulation with bipolar forceps will be conducted. | Procedure: suturing with barbed sutures during laparoscopic ovarian cystectomy<br>* During laparoscopic ovarian cystectomy, suturing of ovarian inner surface will be conducted to stop bleeding<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ovarian function preservation 12 weeks after surgery | Reduction rate of AMH level in serum 12 weeks after surgery | 12 weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ovarian function preservation 48 weeks after surgery | Reduction rate of AMH level in serum 48 weeks after surgery | 48 weeks after surgery | 
| The time required to finish hemostasis | Stop-watch will be operated right after finishing stripping endometrioma. It will be evaluated how long the time have been spent for bleeding control | during operation | 
| the success rate of hemostasis within 10 minutes | Stop-watch will be operated right after finishing stripping endometrioma. It will be evaluated whether hemostasis is finished within 10 minutes | during operation | 
| Blood loss during operation | The volume of blood loss will be estimated by using simple visual assessment technique referring to gauze count and irrigation bottle | during operation | 
| Hemoglobin | Change of serum hemoglobin from baseline | post-op 2 days, 12 weeks and 48 weeks | 
| Transfusion during admission | whether patients are transfused during admission period | post-op 2 days | 
| Adverse events associated with operation, bleeding or transfusion | any adverse events during admission period | post-op 2 days | 
| Hospitalization period | days from admission day to discharge day | within post-op 2 weeks | 
| Operation running time | time from anesthesia start to delivery of patient to recovery room | during operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endometriosis, endometrioma, ovarian cystectomy, ovarian function, ovarian reserve, hemostatic agent, suture