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Study Comparing Hemostatic Agent and Suturing to Preserve Ovarian Function and Control Bleeding During Laparoscopic Ovarian Cystectomy for Endometrioma
Led by Seoul National University Hospital · Updated on 2023-06-26
90
Participants Needed
2
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
This research aims to compare two methods for controlling bleeding during laparoscopic ovarian cystectomy in women with ovarian endometriosis. The study evaluates how well a hemostatic agent versus suturing preserves ovarian function, controls bleeding, and ensures safety during surgery. It focuses on women aged 19 to 45 who are scheduled for this procedure to address benign ovarian cysts caused by endometrioma. Participants will be randomly assigned to one of two groups. In the first group, bleeding is controlled using a hemostatic agent called EVICEL4 Fibrin Sealant, which contains thrombin and coagulating proteins. If bleeding continues, additional methods like electrocoagulation and suturing may be used. The second group uses barbed sutures on the ovarian tissue to stop bleeding, with electrocoagulation as a backup if needed. This approach allows comparison of the hemostatic effectiveness and impact on ovarian tissue. During the study, ovarian function will be assessed before surgery and at 12 and 48 weeks after surgery by measuring Anti-Mullerian Hormone AMH levels and ovarian volume. Researchers will also track blood loss, hemoglobin levels, time to achieve hemostasis, adverse events, and hospital stay length. Participants will be monitored closely to evaluate safety and the preservation of ovarian function over nearly one year after surgery.
CONDITIONS
Brief Title
Comparison of Hemostatic Agent to Suture in Terms of Hemostatic Function and Preservation of Ovarian Function
Research Team
H
Hyunji Lim, MD
H
Hee seung Kim, MD/PhD
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