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

Primary Purpose

Ovarian Cyst Benign

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Surgiguard
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cyst Benign focused on measuring Laparoscopic unilateral ovarian cystectomy, SurgiGuard, Hemostasis, Ovarian function preservation, Bipolar electrocauterization

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

SurgiGuard

Bipolar electrocauterization

Arm Description

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

Bipolar electrocauterization during surgery Drug(-)

Outcomes

Primary Outcome Measures

Hemostasis
Change of serum hemoglobin from baseline

Secondary Outcome Measures

Ovarian function preservation
Change of serum AMH from baseline
Volume of ovary
ovarian volume measured by ultrasonography

Full Information

First Posted
December 10, 2017
Last Updated
December 7, 2019
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03374397
Brief Title
PReservation Study of Ovarian Function And Hemostasis, and Its Safety of Surgiguard@ During Laparoscopic Ovarian Cystectomy
Acronym
PRAHA
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

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
December 6, 2017 (Actual)
Primary Completion Date
August 31, 2019 (Actual)
Study Completion Date
August 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cyst Benign
Keywords
Laparoscopic unilateral ovarian cystectomy, SurgiGuard, Hemostasis, Ovarian function preservation, Bipolar electrocauterization

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SurgiGuard
Arm Type
Active Comparator
Arm Description
Surgiguard Non-woven Drug : SurgiGuard Non-woven 6g during surgery
Arm Title
Bipolar electrocauterization
Arm Type
No Intervention
Arm Description
Bipolar electrocauterization during surgery Drug(-)
Intervention Type
Drug
Intervention Name(s)
Surgiguard
Other Intervention Name(s)
laparoscopic unilateral ovarian cystectomy
Intervention Description
Hemostasis with Surgiguard during laparoscopic unilateral ovarian cystectomy
Primary Outcome Measure Information:
Title
Hemostasis
Description
Change of serum hemoglobin from baseline
Time Frame
post operative 48 hours later,1 week later, and 12 weeks later
Secondary Outcome Measure Information:
Title
Ovarian function preservation
Description
Change of serum AMH from baseline
Time Frame
post operative 48 hours later,1 week later, and 12 weeks later
Title
Volume of ovary
Description
ovarian volume measured by ultrasonography
Time Frame
post operative 48 hours later,1 week later, and 12 weeks later

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hee Seung Kim, MD/PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33875738
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.
Results Reference
derived

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

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