Patients undergoing elective laparoscopic ovarian cystectomy will be recruited and randomly divided into 2 groups according to intervention technique-half will be allocated to the bipolar coagulation group and half to the SURGIFLO group. Patients will be assessed both pre-operatively and 6 months post-operatively by blood tests including follicle stimulating hormone (FSH), lutenizing hormone (LH), Estrogen (E2), Progesterone and anti-mullerian hormone (AMH) levels, and sonographic evaluation of ovarian volume and antral follicle count.
Patients undergoing elective laparoscopic ovarian cystectomy will be recruited after signing an informed consent, and randomly divided into 2 groups according to intervention technique-half will be allocated to the bipolar coagulation group and half to the SURGIFLO group. Patients will be assessed both pre-operatively and 6 months post-operatively by blood tests including FSH, LH, E2, Progesterone and AMH levels, and sonographic evaluation of ovarian volume and antral follicle count. Antral follicle count will be performed on the cyst post-surgery using light microscopy. The difference in hormone levels, especially AMH reflects the damage done during surgery to the ovarian reserve. Sonographic signs including a decrease in ovarian volume and antral follicle count also reflect the damage done during surgery to the ovarian reserve.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
127
Hemostasis of the base of the ovarian cyst by utilization of a bipolar coagulation device.
Hemostasis of the base of the ovarian cyst by utilization of a an absorbable gelatin based matrix known as SURGIFLO.
Rambam health care campus
Haifa, Israel
Decline in ovarian reserve.
Decline rate of AMH levels before and 6 months after surgery.
Time frame: Up to 6 months.
Sonographic decline in ovarian volume
Decline rate of ovarian volume before and 6 months after surgery.
Time frame: Up to 6 months
Sonographic decline in ovarian antral follicle count
Decline rate of ovarian antral follicle count before and 6 months after surgery.
Time frame: Up to 6 months
Changes in FSH levels
Changes in FSH levels before and 6 months after surgery.
Time frame: Up to 6 months.
Changes in LH levels
Changes in LH levels before and 6 months after surgery.
Time frame: Up to 6 months
Changes in Progesterone levels
Changes in Progesterone levels before and 6 months after surgery.
Time frame: Up to 6 months
Changes in E2 levels
Changes in E2 levels before and 6 months after surgery.
Time frame: Up to 6 months
Number of antral follicles in the cyst removed from the ovary.
Number of antral follicles in the cyst removed from the ovary as seen utilizing light microscopy.
Time frame: Up to 6 months.
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