Clinical trial NCT03374397: PReservation Study of Ovarian Function And Hemostasis, and Its Safety of Surgiguard@ During Laparoscopic Ovarian Cystectomy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ovarian Cyst Benign
Keywords: Laparoscopic unilateral ovarian cystectomy
SurgiGuard
Hemostasis
Ovarian function preservation
Bipolar electrocauterization
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-12-15
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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
* 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

Primary outcomes:
measure: Hemostasis
timeFrame: post operative 48 hours later,1 week later, and 12 weeks later
Secondary outcomes:
measure: Ovarian function preservation
timeFrame: post operative 48 hours later,1 week later, and 12 weeks later
measure: Volume of ovary
timeFrame: post operative 48 hours later,1 week later, and 12 weeks later
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Hee Seung Kim, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Park SJ, Seol A, Lee N, Lee S, Kim HS; PRAHA Study Group. A randomized controlled trial of ovarian reserve preservation and hemostasis during ovarian cystectomy. Sci Rep. 2021 Apr 19;11(1):8495. doi: 10.1038/s41598-021-87965-7.