NCT03109964

The Affect of Hemostasis Technique During Laparoscopic Ovarian Cystectomy on Future Fertility

The Affect of Hemostasis With Bipolar Coagulation Versus SURGIFLO Placement on Ovarian Reserve and Future Fertility

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 127 (actual)
• Sponsor: Rambam Health Care Campus · Academic / Other
• Sex: Female
• Age: 18 Years – 44 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cyst Ovary

Interventions

Type	Name	Description
DEVICE	Bipolar coagulation forceps (ETHICON inc.)	Hemostasis of the base of the ovarian cyst by utilization of a bipolar coagulation device.
DEVICE	SURGIFLO hemostatic matrix (ETHICON inc.)	Hemostasis of the base of the ovarian cyst by utilization of a an absorbable gelatin based matrix known as SURGIFLO.

Timeline

• Start date: 2018-11-20
• Primary completion: 2021-03-31
• Completion: 2022-08-01
• First posted: 2017-04-12
• Last updated: 2022-10-26

Locations

1 site across 1 country: Israel