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Clinical Trials in South Korea / NCT04643106
Recruiting Not applicable

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

NCT04643106 · tracked via the Priya Life Science South Korea tracker
Sponsor
Seoul National University Hospital
Phase
Not applicable
Started
2021-02-25
Last updated
2023-06-26

Condition(s) studied

Benign Ovarian Cyst

Investigational drug(s) / intervention(s)

Hemostatic agent (EVICEL®) application during laparoscopic ovarian cystectomysuturing with barbed sutures during laparoscopic ovarian cystectomy

Hemostatic agent (EVICEL®) application during laparoscopic ovarian cystectomy: During laparoscopic ovarian cystectomy, bleeding will be controlled by using a hemostatic agent (EVICEL®)

suturing with barbed sutures during laparoscopic ovarian cystectomy: During laparoscopic ovarian cystectomy, suturing of ovarian inner surface will be conducted to stop bleeding

Study 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.

Eligibility

Sex
FEMALE
Min age
19 Years
Max age
45 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

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

Trial sites (2)

FacilityCityRegionStatus
Dongguk University Ilsan Hospital Goyang-si Gyeonggi-do Not Yet Recruiting
Seoul National University Hospital Seoul South Korea Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04643106 on ClinicalTrials.gov ↗ ← All trials in South Korea