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
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 19
Maximum Age: 45
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Republic of Korea
Dongguk University Ilsan Hospital
NOT_YET_RECRUITING
Goyang-si
Seoul National University Hospital
RECRUITING
Seoul
Contact Information
Primary
Hyunji Lim, MD
hyunji3292@gmail.com
82-2-2072-2821
Backup
Hee seung Kim, MD/PhD
bboddi0311@gmail.com
82-2-2072-4863
Time Frame
Start Date: 2021-02-25
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 90
Treatments
Experimental: Hemostatic agent group
During laparoscopic ovarian cystectomy, bleeding will be controlled by using a hemostatic agent (EVICEL® Fibrin Sealant, Ethicon, USA), which consist of thrombin and coagulating proteins, mainly fibrinogen and fibronectin. If hemostasis is not fulfilled enough by using it, a additional intervention such as electrocoagulation with bipolar forceps and barbed suture is required to stop bleeding.
Active_comparator: Suturing group
During operation, barbed suture will be applied to the inner surface of ovarian parenchyme where ovarian endometriosis was attached. In this group, if bleeding is continued after suturing, additional electrocoagulation with bipolar forceps will be conducted.
Related Therapeutic Areas
Sponsors
Leads: Seoul National University Hospital