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

December 7, 2019 updated by: Hee Seung Kim, Seoul National University Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: SurgiGuard
Surgiguard Non-woven Drug : SurgiGuard Non-woven 6g during surgery
Drug: Surgiguard
Hemostasis with Surgiguard during laparoscopic unilateral ovarian cystectomy
Other Names:
  • laparoscopic unilateral ovarian cystectomy
NO_INTERVENTION: Bipolar electrocauterization
Bipolar electrocauterization during surgery Drug(-)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 6, 2017

Primary Completion (ACTUAL)

August 31, 2019

Study Completion (ACTUAL)

August 31, 2019

Study Registration Dates

First Submitted

December 10, 2017

First Submitted That Met QC Criteria

December 13, 2017

First Posted (ACTUAL)

December 15, 2017

Study Record Updates

Last Update Posted (ACTUAL)

December 10, 2019

Last Update Submitted That Met QC Criteria

December 7, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-1707

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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