Menu
Recruiting NCT04643106

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

No phase Interventional Benign Ovarian Cyst

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hemostatic agent (EVICEL®) application during laparoscopic ovarian cystectomy, suturing with barbed sutures during laparoscopic ovarian cystectomy.
Who it may be relevant to
Registry conditions: Benign Ovarian Cyst. Basic parameters: 19 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Procedure Hemostatic agent (EVICEL®) application during laparoscopic ovarian cystectomy
    During laparoscopic ovarian cystectomy, bleeding will be controlled by using a hemostatic agent (EVICEL®)
  • Procedure suturing with barbed sutures during laparoscopic ovarian cystectomy
    During laparoscopic ovarian cystectomy, suturing of ovarian inner surface will be conducted to stop bleeding

Primary outcome measures

  • Ovarian function preservation 12 weeks after surgery [Time frame: 12 weeks after surgery]
Secondary outcome measures (9)
  • Ovarian function preservation 48 weeks after surgery [Time frame: 48 weeks after surgery]
  • The time required to finish hemostasis [Time frame: during operation]
  • the success rate of hemostasis within 10 minutes [Time frame: during operation]
  • Blood loss during operation [Time frame: during operation]
  • Hemoglobin [Time frame: post-op 2 days, 12 weeks and 48 weeks]
  • Transfusion during admission [Time frame: post-op 2 days]
  • Adverse events associated with operation, bleeding or transfusion [Time frame: post-op 2 days]
  • Hospitalization period [Time frame: within post-op 2 weeks]
  • Operation running time [Time frame: during operation]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

South Korea · 2 centers
  • Dongguk University Ilsan Hospital — Goyang-si
  • Seoul National University Hospital — Seoul

Publications

  • 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: 1 PMID 34289889

Identifiers

NCT: NCT04643106 · 2008-059-1147

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗