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

Seoul National University Hospital52 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ovarian Cyst Benign

Interventions

SurgiguardDRUG

Hemostasis with Surgiguard during laparoscopic unilateral ovarian cystectomy

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Hemostasis

Change of serum hemoglobin from baseline

Time frame: post operative 48 hours later,1 week later, and 12 weeks later

Secondary Outcomes

Ovarian function preservation

Change of serum AMH from baseline

Time frame: post operative 48 hours later,1 week later, and 12 weeks later

Volume of ovary

ovarian volume measured by ultrasonography

Time frame: post operative 48 hours later,1 week later, and 12 weeks later

Data from ClinicalTrials.gov

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