Comparison of Hemostatic Agent to Suture in Terms of Hemostatic Function and Preservation of Ovarian Function
PRAHA-2
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
1 other identifier
interventional
90
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2021
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 1, 2020
CompletedFirst Posted
Study publicly available on registry
November 24, 2020
CompletedStudy Start
First participant enrolled
February 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
ExpectedJune 26, 2023
June 1, 2023
4.8 years
November 1, 2020
June 23, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ovarian function preservation 12 weeks after surgery
Reduction rate of AMH level in serum 12 weeks after surgery
12 weeks after surgery
Secondary Outcomes (9)
Ovarian function preservation 48 weeks after surgery
48 weeks after surgery
The time required to finish hemostasis
during operation
the success rate of hemostasis within 10 minutes
during operation
Blood loss during operation
during operation
Hemoglobin
post-op 2 days, 12 weeks and 48 weeks
- +4 more secondary outcomes
Study Arms (2)
Hemostatic agent group
EXPERIMENTALDuring 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.
Suturing group
ACTIVE COMPARATORDuring 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.
Interventions
During laparoscopic ovarian cystectomy, bleeding will be controlled by using a hemostatic agent (EVICEL®)
During laparoscopic ovarian cystectomy, suturing of ovarian inner surface will be conducted to stop bleeding
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Dongguk University Ilsan Hospital
Goyang-si, Gyeonggi-do, 10326, South Korea
Seoul National University Hospital
Seoul, South Korea
Related Publications (1)
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.
PMID: 34289889DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hee seung Kim, MD/PhD
Seoul National University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- associate professor
Study Record Dates
First Submitted
November 1, 2020
First Posted
November 24, 2020
Study Start
February 25, 2021
Primary Completion
December 31, 2025
Study Completion (Estimated)
December 31, 2026
Last Updated
June 26, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share