Actively Recruiting
Led by Seoul National University Hospital · Updated on 2023-06-26
90
Participants Needed
2
Research Sites
52 weeks
Total Duration
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
Comparison of Hemostatic Agent to Suture in Terms of Hemostatic Function and Preservation of Ovarian Function
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery and hospital stay within 2 weeks post-operation
Participants undergo laparoscopic ovarian cystectomy with either hemostatic agent application or suturing to control bleeding during the operation.
1 surgery visit and hospital stay up to 2 weeks
Duration - Up to 48 weeks after surgery
Participants are monitored for ovarian function preservation, hemoglobin levels, and adverse events after surgery.
Visits at 2 days, 12 weeks, and 48 weeks post-operation
Total: 2 locations
1
Dongguk University Ilsan Hospital
Goyang-si, Gyeonggi-do, South Korea, 10326
Not Yet Recruiting
2
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
H
Hyunji Lim, MD
H
Hee seung Kim, MD/PhD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Hyunji Lim, Soo Jin Park, Haerin Paik...
https://pubmed.ncbi.nlm.nih.gov/34289889