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

Phase 3

Completed

• Conditions: Ovarian Cyst Benign
• Interventions: Drug: Surgiguard

• Registration Number: NCT03374397
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

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 Timeline

• Study Start: 2017-12-06
• Study First Submitted: 2017-12-10
• Study First Submitted QC: 2017-12-13
• Study First Posted: 2017-12-15
• Primary Completion: 2019-08-31
• Study Completion: 2019-08-31
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-07
• Last Update Posted: 2019-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SurgiGuard	Surgiguard	Surgiguard Non-woven Drug : SurgiGuard Non-woven 6g during surgery

Primary Outcome Measures

Name	Time	Method
Hemostasis	post operative 48 hours later,1 week later, and 12 weeks later	Change of serum hemoglobin from baseline

Secondary Outcome Measures

Name	Time	Method
Ovarian function preservation	post operative 48 hours later,1 week later, and 12 weeks later	Change of serum AMH from baseline
Volume of ovary	post operative 48 hours later,1 week later, and 12 weeks later	ovarian volume measured by ultrasonography

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of