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

Overview

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.

Full Title of Study: “The Affect of Hemostasis With Bipolar Coagulation Versus SURGIFLO Placement on Ovarian Reserve and Future Fertility”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: March 31, 2021

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Active Comparator: Hemostasis with bipolar coagulation
    • Patients undergoing laparoscopic ovarian cystectomy with bipolar coagulation hemostasis.
  • Experimental: Hemostasis with SURGIFLO
    • Patients undergoing laparoscopic ovarian cystectomy with SURGIFLO hemostasis.

Clinical Trial Outcome Measures

Primary Measures

  • Decline in ovarian reserve.
    • Time Frame: Up to 6 months.
    • Decline rate of AMH levels before and 6 months after surgery.

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Female patients with operable ovarian cysts with clear indication for surgery.

Minimum Age: 18 Years

Maximum Age: 44 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Rambam Health Care Campus
  • Provider of Information About this Clinical Study
    • Principal Investigator: ROY LAUTERBACH MD, Principal Investigator – Rambam Health Care Campus
  • Overall Official(s)
    • Roy Lauterbach, MD, Principal Investigator, Rambam Health Care Campus

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