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

• Status: Completed
• Trial end date: 2019-08-31
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital

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

• 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