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.
In women with endometrioma who plan to undergo laparoscopic ovarian cystectomy, surgical technique can influence postoperative ovarian function because of removal of normal ovarian tissue with ovarian cyst and damage to ovarian tissue during bleeding control after stripping of endometrioma. This study is designed to compare hemostatic sealant to suturing in terms of hemostatic function, safety and preservation of ovarian function. Ovarian function of all patients will be evaluated on pre op, post op 12 weeks, post op 48 weeks by measuring AMH and ovarian volume. And Hemostatic function will be evaluated by measuring serum hemoglobin, blood loss during operation, etc.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
During laparoscopic ovarian cystectomy, bleeding will be controlled by using a hemostatic agent (EVICEL®)
During laparoscopic ovarian cystectomy, suturing of ovarian inner surface will be conducted to stop bleeding
Dongguk University Ilsan Hospital
Goyang-si, Gyeonggi-do, South Korea
NOT_YET_RECRUITINGSeoul National University Hospital
Seoul, South Korea
RECRUITINGOvarian function preservation 12 weeks after surgery
Reduction rate of AMH level in serum 12 weeks after surgery
Time frame: 12 weeks after surgery
Ovarian function preservation 48 weeks after surgery
Reduction rate of AMH level in serum 48 weeks after surgery
Time frame: 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
Time frame: during operation
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
Time frame: during operation
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
Time frame: during operation
Hemoglobin
Change of serum hemoglobin from baseline
Time frame: post-op 2 days, 12 weeks and 48 weeks
Transfusion during admission
whether patients are transfused during admission period
Time frame: post-op 2 days
Adverse events associated with operation, bleeding or transfusion
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any adverse events during admission period
Time frame: post-op 2 days
Hospitalization period
days from admission day to discharge day
Time frame: within post-op 2 weeks
Operation running time
time from anesthesia start to delivery of patient to recovery room
Time frame: during operation