About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
No 'ovarian' endometriosis
Suspicious disease of ovarian malignancy
Age: 18 and younger, 46 and older
Pregnancy or breastfeeding.
Trial design
Parallel
Treatments tested in this trial
Hemostatic agent (EVICEL®) application during laparoscopic ovarian cystectomy
Procedure/SurgeryDuring laparoscopic ovarian cystectomy, bleeding will be controlled by using a hemostatic agent (EVICEL®)
suturing with barbed sutures during laparoscopic ovarian cystectomy
Procedure/SurgeryDuring laparoscopic ovarian cystectomy, suturing of ovarian inner surface will be conducted to stop bleeding
Treatment groups
Trial outcomes
Primary outcomes
Ovarian function preservation 12 weeks after surgery
Reduction rate of AMH level in serum 12 weeks after surgery
Secondary outcomes
Ovarian function preservation 48 weeks after surgery
Reduction rate of AMH level in serum 48 weeks after surgery
The time required to finish hemostasis
Stop-watch will be operated right after finishing stripping endometrioma. It will be evaluated how long the time have been spent for bleeding control
the success rate of hemostasis within 10 minutes
Stop-watch will be operated right after finishing stripping endometrioma. It will be evaluated whether hemostasis is finished within 10 minutes
Blood loss during operation
The volume of blood loss will be estimated by using simple visual assessment technique referring to gauze count and irrigation bottle
Sponsors and contacts
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