Comparing a hemostatic agent to sutures for ovarian cyst surgery
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
Run by Seoul National University Hospital · NCT04643106 · Data updated 2026-11-12
This study tests whether using a special hemostatic agent instead of stitches during ovarian cyst surgery helps women with endometriomas recover better and keep their ovaries healthy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 19 Years to 45 Years |
| Sex | Women only |
| Enrollment | 90 (estimated) |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 2 sites (Goyang-si, Gyeonggi-do and 1 other locations) |
| Status | Recruiting |
| Started | February 25, 2021 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2026 |
| Registry record updated | June 26, 2023 |
| Trial ID | NCT04643106 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 19-45 with a diagnosis of unilateral or bilateral ovarian endometriosis planning to undergo laparoscopic ovarian cystectomy.
✕Probably not a fit
Patients with ovarian malignancy, those under 19 or over 45, or those with hormonal therapy in the last three months may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of a hemostatic agent compared to traditional suturing during laparoscopic ovarian cystectomy in women with endometriomas. It focuses on how these methods impact hemostatic function and the preservation of ovarian function post-surgery. Patients will be assessed for ovarian function through hormone levels and ovarian volume at various intervals after the procedure. The study aims to determine which technique is safer and more effective in maintaining ovarian health.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and better preservation of ovarian function for women undergoing cystectomy.
How similar studies have gone: While this approach is being evaluated, similar studies have shown promise in improving surgical outcomes, though this specific comparison may be novel.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Seoul National University Hospital
Seoul, South Korea Recruiting -
Dongguk University Ilsan Hospital
Goyang-si, Gyeonggi-do, South Korea Not yet recruiting
Study contacts
- Principal investigator: Hee seung Kim, MD/PhD — Seoul National University Hospital
- Study coordinator: Hyunji Lim, MD
- Email: hyunji3292@gmail.com
- Phone: 82-2-2072-2821
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.