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
Overview
- Phase
- Phase 3
- Intervention
- Surgiguard
- Conditions
- Ovarian Cyst Benign
- Sponsor
- Seoul National University Hospital
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Hemostasis
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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
Investigators
Hee Seung Kim
Associate Professor, Department of Obstetrics & Gynecology
Seoul National University Hospital
Eligibility Criteria
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
- •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
Arms & Interventions
SurgiGuard
Surgiguard Non-woven Drug : SurgiGuard Non-woven 6g during surgery
Intervention: Surgiguard
Outcomes
Primary Outcomes
Hemostasis
Time Frame: post operative 48 hours later,1 week later, and 12 weeks later
Change of serum hemoglobin from baseline
Secondary Outcomes
- Ovarian function preservation(post operative 48 hours later,1 week later, and 12 weeks later)
- Volume of ovary(post operative 48 hours later,1 week later, and 12 weeks later)