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

Not Applicable

Completed

• Conditions: Cyst Ovary
• Interventions: Device: SURGIFLO hemostatic matrix (ETHICON inc.); Device: Bipolar coagulation forceps (ETHICON inc.)

• Registration Number: NCT03109964
• Lead Sponsor: Rambam Health Care Campus

Brief 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.

Study Timeline

• Study First Submitted: 2017-03-29
• Study First Submitted QC: 2017-04-11
• Study First Posted: 2017-04-12
• Study Start: 2018-11-20
• Primary Completion: 2021-03-31
• Study Completion: 2022-08-01
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-24
• Last Update Posted: 2022-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 127

Inclusion Criteria

• Female patients with benign ovarian cysts that are interested in future fertility ages 18-44.

Exclusion Criteria

• Female patients with malignant ovarian cysts/masses.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hemostasis with SURGIFLO	SURGIFLO hemostatic matrix (ETHICON inc.)	Patients undergoing laparoscopic ovarian cystectomy with SURGIFLO hemostasis.
Hemostasis with bipolar coagulation	Bipolar coagulation forceps (ETHICON inc.)	Patients undergoing laparoscopic ovarian cystectomy with bipolar coagulation hemostasis.

Primary Outcome Measures

Name	Time	Method
Decline in ovarian reserve.	Up to 6 months.	Decline rate of AMH levels before and 6 months after surgery.

Secondary Outcome Measures

Name	Time	Method
Number of antral follicles in the cyst removed from the ovary.	Up to 6 months.	Number of antral follicles in the cyst removed from the ovary as seen utilizing light microscopy.
Changes in Progesterone levels	Up to 6 months	Changes in Progesterone levels before and 6 months after surgery.
Changes in E2 levels	Up to 6 months	Changes in E2 levels before and 6 months after surgery.
Sonographic decline in ovarian antral follicle count	Up to 6 months	Decline rate of ovarian antral follicle count before and 6 months after surgery.
Changes in FSH levels	Up to 6 months.	Changes in FSH levels before and 6 months after surgery.
Sonographic decline in ovarian volume	Up to 6 months	Decline rate of ovarian volume before and 6 months after surgery.
Changes in LH levels	Up to 6 months	Changes in LH levels before and 6 months after surgery.

Trial Locations

Locations (1)

Rambam health care campus; 🇮🇱 Haifa, Israel