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

Primary Purpose

Benign Ovarian Cyst

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Hemostatic agent (EVICEL®) application during laparoscopic ovarian cystectomy
suturing with barbed sutures during laparoscopic ovarian cystectomy
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Ovarian Cyst focused on measuring endometriosis, endometrioma, ovarian cystectomy, ovarian function, ovarian reserve, hemostatic agent, suture

Eligibility Criteria

19 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Dongguk University Ilsan Hospital
  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hemostatic agent group

Suturing group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Ovarian function preservation 12 weeks after surgery
Reduction rate of AMH level in serum 12 weeks after surgery

Secondary Outcome Measures

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

Full Information

First Posted
November 1, 2020
Last Updated
June 23, 2023
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04643106
Brief Title
Comparison of Hemostatic Agent to Suture in Terms of Hemostatic Function and Preservation of Ovarian Function
Acronym
PRAHA-2
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 25, 2021 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

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
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Ovarian Cyst
Keywords
endometriosis, endometrioma, ovarian cystectomy, ovarian function, ovarian reserve, hemostatic agent, suture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hemostatic agent group
Arm Type
Experimental
Arm Description
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.
Arm Title
Suturing group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Hemostatic agent (EVICEL®) application during laparoscopic ovarian cystectomy
Intervention Description
During laparoscopic ovarian cystectomy, bleeding will be controlled by using a hemostatic agent (EVICEL®)
Intervention Type
Procedure
Intervention Name(s)
suturing with barbed sutures during laparoscopic ovarian cystectomy
Intervention Description
During laparoscopic ovarian cystectomy, suturing of ovarian inner surface will be conducted to stop bleeding
Primary Outcome Measure Information:
Title
Ovarian function preservation 12 weeks after surgery
Description
Reduction rate of AMH level in serum 12 weeks after surgery
Time Frame
12 weeks after surgery
Secondary Outcome Measure Information:
Title
Ovarian function preservation 48 weeks after surgery
Description
Reduction rate of AMH level in serum 48 weeks after surgery
Time Frame
48 weeks after surgery
Title
The time required to finish hemostasis
Description
Stop-watch will be operated right after finishing stripping endometrioma. It will be evaluated how long the time have been spent for bleeding control
Time Frame
during operation
Title
the success rate of hemostasis within 10 minutes
Description
Stop-watch will be operated right after finishing stripping endometrioma. It will be evaluated whether hemostasis is finished within 10 minutes
Time Frame
during operation
Title
Blood loss during operation
Description
The volume of blood loss will be estimated by using simple visual assessment technique referring to gauze count and irrigation bottle
Time Frame
during operation
Title
Hemoglobin
Description
Change of serum hemoglobin from baseline
Time Frame
post-op 2 days, 12 weeks and 48 weeks
Title
Transfusion during admission
Description
whether patients are transfused during admission period
Time Frame
post-op 2 days
Title
Adverse events associated with operation, bleeding or transfusion
Description
any adverse events during admission period
Time Frame
post-op 2 days
Title
Hospitalization period
Description
days from admission day to discharge day
Time Frame
within post-op 2 weeks
Title
Operation running time
Description
time from anesthesia start to delivery of patient to recovery room
Time Frame
during operation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyunji Lim, MD
Phone
82-2-2072-2821
Email
hyunji3292@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hee seung Kim, MD/PhD
Phone
82-2-2072-4863
Email
bboddi0311@gmail.com
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
Dongguk University Ilsan Hospital
City
Goyang-si
State/Province
Gyeonggi
ZIP/Postal Code
10326
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ga Won Yim, MD/PhD
Phone
82-31-961-7366
Email
gawonyim@gmail.com
First Name & Middle Initial & Last Name & Degree
Chae Hyeong Lee, MD/PhD
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyunji Lim, MD
Phone
82-2-2072-2643
Email
hyunji3292@gmail.com
First Name & Middle Initial & Last Name & Degree
Hee Seung Kim, MD/PhD
Phone
82-2-2072-4863
Email
bboddi0311@gmail.com
First Name & Middle Initial & Last Name & Degree
Hee Seung Kim, MD/PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34289889
Citation
Lim H, Park SJ, Paik H, Mun J, Lee EJ, Lee S, Lim W, Song G, Shim SH, Lee CH, Yim GW, Kim HS; PRAHA Study Group. Preservation of the ovarian reserve and hemostasis during laparoscopic ovarian cystectomy by a hemostatic agent versus suturing for patients with ovarian endometriosis: study protocol for randomized controlled, non-inferiority trial (PRAHA-2 trial). Trials. 2021 Jul 21;22(1):473. doi: 10.1186/s13063-021-05431-1.
Results Reference
derived

Learn more about this trial

Comparison of Hemostatic Agent to Suture in Terms of Hemostatic Function and Preservation of Ovarian Function

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