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

Seoul National University

Status and phase

Completed

Phase 3

Conditions

Ovarian Cyst Benign

Treatments

Drug: Surgiguard

Study type

Interventional

Funder types

Other

Identifiers

NCT03374397

2017-1707

Details and patient eligibility

About

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

Full 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

Enrollment

52 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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