Comparison of Hemostatic Agent to Suture in Terms of Hemostatic Function and Preservation of Ovarian Function (PRAHA-2)

June 23, 2023 updated by: Hee Seung Kim, Seoul National University Hospital

A Multi-center, Randomized, Investigator-initiated Trial to Evaluate the Efficacy of PRreservation of ovArian Function, Hemostasis, and sAfety of a Hemostatic Agent Versus Suturing During Laparoscopic Ovarian Cystectomy for Endometrioma

This study aims to evaluate the efficacy of preservation of ovarian function, hemostasis, and safety of a hemostatic agent versus suturing during laparoscopic ovarian cystectomy for ovarian endometriosis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In women with endometrioma who plan to undergo laparoscopic ovarian cystectomy, surgical technique can influence postoperative ovarian function because of removal of normal ovarian tissue with ovarian cyst and damage to ovarian tissue during bleeding control after stripping of endometrioma. This study is designed to compare hemostatic sealant to suturing in terms of hemostatic function, safety and preservation of ovarian function.

Ovarian function of all patients will be evaluated on pre op, post op 12 weeks, post op 48 weeks by measuring AMH and ovarian volume. And Hemostatic function will be evaluated by measuring serum hemoglobin, blood loss during operation, etc.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hee Seung Kim, MD/PhD
    • Gyeonggi
      • Goyang-si, Gyeonggi, Korea, Republic of, 10326
        • Not yet recruiting
        • DongGuk University ilsan Hospital
        • Contact:
        • Principal Investigator:
          • Chae Hyeong Lee, MD/PhD

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

19 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Informed consent.
  • Age: 19-45 year-old women
  • American Society of Anesthesiologists Physical Status classification 1 or 2
  • Plan of laparoscopic ovarian cystectomy for unilateral or bilateral ovarian endometriosis diagnosed by ultrasonography
  • Regular menstruation every 21-45 days

Exclusion Criteria:

  • No 'ovarian' endometriosis
  • Suspicious disease of ovarian malignancy
  • Age: 18 and younger, 46 and older
  • Pregnancy or breastfeeding.
  • Lower than 0.05 ng/ml of serum Anti-mullerian hormone level
  • Hormonal therapy within recent 3 months
  • Considered as inappropriate by the researcher's judgment.

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hemostatic agent group
During laparoscopic ovarian cystectomy, bleeding will be controlled by using a hemostatic agent (EVICEL® Fibrin Sealant, Ethicon, USA), which consist of thrombin and coagulating proteins, mainly fibrinogen and fibronectin. If hemostasis is not fulfilled enough by using it, a additional intervention such as electrocoagulation with bipolar forceps and barbed suture is required to stop bleeding.
Procedure: Hemostatic agent (EVICEL®) application during laparoscopic ovarian cystectomy
During laparoscopic ovarian cystectomy, bleeding will be controlled by using a hemostatic agent (EVICEL®)
Active Comparator: Suturing group
During operation, barbed suture will be applied to the inner surface of ovarian parenchyme where ovarian endometriosis was attached. In this group, if bleeding is continued after suturing, additional electrocoagulation with bipolar forceps will be conducted.
Procedure: suturing with barbed sutures during laparoscopic ovarian cystectomy
During laparoscopic ovarian cystectomy, suturing of ovarian inner surface will be conducted to stop bleeding

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ovarian function preservation 12 weeks after surgery
Time Frame: 12 weeks after surgery
Reduction rate of AMH level in serum 12 weeks after surgery
12 weeks after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ovarian function preservation 48 weeks after surgery
Time Frame: 48 weeks after surgery
Reduction rate of AMH level in serum 48 weeks after surgery
48 weeks after surgery
The time required to finish hemostasis
Time Frame: during operation
Stop-watch will be operated right after finishing stripping endometrioma. It will be evaluated how long the time have been spent for bleeding control
during operation
the success rate of hemostasis within 10 minutes
Time Frame: during operation
Stop-watch will be operated right after finishing stripping endometrioma. It will be evaluated whether hemostasis is finished within 10 minutes
during operation
Blood loss during operation
Time Frame: during operation
The volume of blood loss will be estimated by using simple visual assessment technique referring to gauze count and irrigation bottle
during operation
Hemoglobin
Time Frame: post-op 2 days, 12 weeks and 48 weeks
Change of serum hemoglobin from baseline
post-op 2 days, 12 weeks and 48 weeks
Transfusion during admission
Time Frame: post-op 2 days
whether patients are transfused during admission period
post-op 2 days
Adverse events associated with operation, bleeding or transfusion
Time Frame: post-op 2 days
any adverse events during admission period
post-op 2 days
Hospitalization period
Time Frame: within post-op 2 weeks
days from admission day to discharge day
within post-op 2 weeks
Operation running time
Time Frame: during operation
time from anesthesia start to delivery of patient to recovery room
during operation

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Hee Seung Kim, MD/PhD, 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)

February 25, 2021

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

November 1, 2020

First Submitted That Met QC Criteria

November 22, 2020

First Posted (Actual)

November 24, 2020

Study Record Updates

Last Update Posted (Actual)

June 26, 2023

Last Update Submitted That Met QC Criteria

June 23, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-059-1147

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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