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

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.

Study Overview

• Status: Completed
• Conditions: Cyst Ovary
• Intervention / Treatment: Device: Bipolar coagulation forceps (ETHICON inc.); Device: SURGIFLO hemostatic matrix (ETHICON inc.)

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 Type: Interventional
• Enrollment (Actual): 127
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Rambam Health Care Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 44 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Hemostasis with bipolar coagulation; Patients undergoing laparoscopic ovarian cystectomy with bipolar coagulation hemostasis.	Device: Bipolar coagulation forceps (ETHICON inc.); Hemostasis of the base of the ovarian cyst by utilization of a bipolar coagulation device.
EXPERIMENTAL: Hemostasis with SURGIFLO; Patients undergoing laparoscopic ovarian cystectomy with SURGIFLO hemostasis.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decline in ovarian reserve.	Decline rate of AMH levels before and 6 months after surgery.	Up to 6 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sonographic decline in ovarian volume	Decline rate of ovarian volume before and 6 months after surgery.	Up to 6 months
Sonographic decline in ovarian antral follicle count	Decline rate of ovarian antral follicle count before and 6 months after surgery.	Up to 6 months
Changes in FSH levels	Changes in FSH levels before and 6 months after surgery.	Up to 6 months.
Changes in LH levels	Changes in LH levels before and 6 months after surgery.	Up to 6 months
Changes in Progesterone levels	Changes in Progesterone levels before and 6 months after surgery.	Up to 6 months
Changes in E2 levels	Changes in E2 levels before and 6 months after surgery.	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.	Up to 6 months.

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 20, 2018
• Primary Completion (ACTUAL): March 31, 2021
• Study Completion (ACTUAL): August 1, 2022

Study Registration Dates

• First Submitted: March 29, 2017
• First Submitted That Met QC Criteria: April 11, 2017
• First Posted (ACTUAL): April 12, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 26, 2022
• Last Update Submitted That Met QC Criteria: October 24, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Endocrine System Diseases; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Ovarian Cysts; Coagulants; Hemostatics; Surgiflo
• Other Study ID Numbers: 0232-17-RMB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No