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

NCT03374397 | Completed Phase 3

• 1 other identifier: 2017-1707
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

Conditions

Ovarian Cyst Benign

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Hemostasis

  Change of serum hemoglobin from baseline

  post operative 48 hours later,1 week later, and 12 weeks later

Secondary Outcomes (2)

• Ovarian function preservation

  post operative 48 hours later,1 week later, and 12 weeks later

• Volume of ovary

  post operative 48 hours later,1 week later, and 12 weeks later

Study Arms (2)

SurgiGuard

ACTIVE COMPARATOR

Surgiguard Non-woven Drug : SurgiGuard Non-woven 6g during surgery

Drug: Surgiguard

Bipolar electrocauterization

NO INTERVENTION

Bipolar electrocauterization during surgery Drug(-)

Interventions

Surgiguard DRUG

Hemostasis with Surgiguard during laparoscopic unilateral ovarian cystectomy

Also known as: laparoscopic unilateral ovarian cystectomy

SurgiGuard

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 33875738 DERIVED

Study Officials

• Hee Seung Kim, MD/PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Obstetrics & Gynecology

Study Record Dates

• First Submitted: December 10, 2017
• First Posted: December 15, 2017
• Study Start: December 6, 2017
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2019
• Last Updated: December 10, 2019

Record last verified: 2019-12

Locations

KR (1)