Status:
COMPLETED
PReservation Study of Ovarian Function And Hemostasis, and Its Safety of Surgiguard@ During Laparoscopic Ovarian Cystectomy
Lead Sponsor:
Seoul National University Hospital
Conditions:
Ovarian Cyst Benign
Eligibility:
FEMALE
18-45 years
Phase:
PHASE3
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 ovari...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2019
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT03374397
Start Date
December 6 2017
End Date
August 31 2019
Last Update
December 10 2019
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea