Comparing a hemostatic agent to sutures for ovarian cyst surgery
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 19 Years to 45 Years |
| Sex | Female |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 2 sites (Goyang-si, Gyeonggi-do and 1 other locations) |
| Trial ID | NCT04643106 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women aged 19-45 with a diagnosis of unilateral or bilateral ovarian endometriosis planning to undergo laparoscopic ovarian cystectomy.
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.
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 performed: While this approach is being evaluated, similar studies have shown promise in improving surgical outcomes, though this specific comparison may be novel.
Eligibility criteria
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 this trial is running
Goyang-si, Gyeonggi-do and 1 other locations
- Dongguk University Ilsan Hospital — Goyang-si, Gyeonggi-do, South Korea (Not_yet_recruiting)
- Seoul National University Hospital — Seoul, South Korea (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.