PReservation Study of Ovarian Function And Hemostasis, and Its Safety of Surgiguard@ During Laparoscopic Ovarian Cystectomy

Study Overview
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Brief Summary
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The purpose of this study is to compare hemostasis, ovarian function preservation effect, and safety about intraoperative bleeding with SurgiGuard@ in women who underwent laparoscopic unilateral ovarian cystectomy

Detailed Description
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In women who underwent laparoscopic unilateral ovarian cystectomy, the effect of SurgiGuard@ was assessed by randomization, using SurgiGuard@ and Bipolar electro cauterization, followed by comparative evaluation of hemostasis, ovarian function preservation, safety using postoperative Hb, anti-mullerian hormone (AMH), pelvis ultrasonography (USG), and physical examination

Official Title
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A Single Center, Randomized, Investigator-initiated Phase III Trial to Evaluate the Efficacy of Preservation of Ovarian Function and Hemostasis, and Its Safety of Surgiguard@ During Laparoscopic Ovarian Cystectomy

Conditions
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Ovarian Cyst Benign

Intervention / Treatment
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* Drug: Surgiguard


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female, 18 years ≤ Ages <45 years laparoscopic unilateral ovarian cystectomy scheduled patients with benign unilateral ovarian cyst confirmed by ultrasonography women with regular menstruation women with regular menstruation cycle from 21 days to 45 days Proper state for laparoscopic operation (American society of Anesthesiologists Physical Status classification 1 or 2) Patients who signed and approved informed consent Exclusion Criteria: Patients without ovarian cyst Patients with malignant female genital disease Patients with bilateral ovarian cysts Age ≥ 45 Pregnancy or lactating women Serum AMH<0.05 ng/ml Patients with endocrine disease such as thyroid abnormality, hyperprolactinemia, cushing disease, etc Patients with hormone replacement therapy during 3 months Patients who is considered to be difficult to perform the clinical trial when researchers judge

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Active Comparator: SurgiGuard<br>Surgiguard Non-woven Drug : SurgiGuard Non-woven 6g during surgery | Drug: Surgiguard<br>* Hemostasis with Surgiguard during laparoscopic unilateral ovarian cystectomy<br>* Other names: laparoscopic unilateral ovarian cystectomy;|
| No Intervention: Bipolar electrocauterization<br>Bipolar electrocauterization during surgery Drug(-) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemostasis | Change of serum hemoglobin from baseline | post operative 48 hours later,1 week later, and 12 weeks later | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ovarian function preservation | Change of serum AMH from baseline | post operative 48 hours later,1 week later, and 12 weeks later | 
| Volume of ovary | ovarian volume measured by ultrasonography | post operative 48 hours later,1 week later, and 12 weeks later | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopic unilateral ovarian cystectomy, SurgiGuard, Hemostasis, Ovarian function preservation, Bipolar electrocauterization