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

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

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

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