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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03374397

Acronym

PRAHA

Enrollment

Registered

2017-12-15

Start date

2017-12-06

Completion date

2019-08-31

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cyst Benign

Keywords

Laparoscopic unilateral ovarian cystectomy, SurgiGuard, Hemostasis, Ovarian function preservation, Bipolar electrocauterization

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

Interventions

DRUGSurgiguard

Hemostasis with Surgiguard during laparoscopic unilateral ovarian cystectomy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Hemostasis	post operative 48 hours later,1 week later, and 12 weeks later	Change of serum hemoglobin from baseline

Secondary

Measure	Time frame	Description
Ovarian function preservation	post operative 48 hours later,1 week later, and 12 weeks later	Change of serum AMH from baseline
Volume of ovary	post operative 48 hours later,1 week later, and 12 weeks later	ovarian volume measured by ultrasonography

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026