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

Primary Purpose

Cyst Ovary

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Bipolar coagulation forceps (ETHICON inc.)
SURGIFLO hemostatic matrix (ETHICON inc.)
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cyst Ovary

Eligibility Criteria

18 Years - 44 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Rambam health care campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Hemostasis with bipolar coagulation

Hemostasis with SURGIFLO

Arm Description

Patients undergoing laparoscopic ovarian cystectomy with bipolar coagulation hemostasis.

Patients undergoing laparoscopic ovarian cystectomy with SURGIFLO hemostasis.

Outcomes

Primary Outcome Measures

Decline in ovarian reserve.
Decline rate of AMH levels before and 6 months after surgery.

Secondary Outcome Measures

Sonographic decline in ovarian volume
Decline rate of ovarian volume before and 6 months after surgery.
Sonographic decline in ovarian antral follicle count
Decline rate of ovarian antral follicle count before and 6 months after surgery.
Changes in FSH levels
Changes in FSH levels before and 6 months after surgery.
Changes in LH levels
Changes in LH levels before and 6 months after surgery.
Changes in Progesterone levels
Changes in Progesterone levels before and 6 months after surgery.
Changes in E2 levels
Changes in E2 levels before and 6 months after surgery.
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.

Full Information

First Posted
March 29, 2017
Last Updated
October 24, 2022
Sponsor
Rambam Health Care Campus
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1. Study Identification

Unique Protocol Identification Number
NCT03109964
Brief Title
The Affect of Hemostasis Technique During Laparoscopic Ovarian Cystectomy on Future Fertility
Official Title
The Affect of Hemostasis With Bipolar Coagulation Versus SURGIFLO Placement on Ovarian Reserve and Future Fertility
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
November 20, 2018 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
August 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rambam Health Care Campus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cyst Ovary

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
127 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hemostasis with bipolar coagulation
Arm Type
Active Comparator
Arm Description
Patients undergoing laparoscopic ovarian cystectomy with bipolar coagulation hemostasis.
Arm Title
Hemostasis with SURGIFLO
Arm Type
Experimental
Arm Description
Patients undergoing laparoscopic ovarian cystectomy with SURGIFLO hemostasis.
Intervention Type
Device
Intervention Name(s)
Bipolar coagulation forceps (ETHICON inc.)
Intervention Description
Hemostasis of the base of the ovarian cyst by utilization of a bipolar coagulation device.
Intervention Type
Device
Intervention Name(s)
SURGIFLO hemostatic matrix (ETHICON inc.)
Intervention Description
Hemostasis of the base of the ovarian cyst by utilization of a an absorbable gelatin based matrix known as SURGIFLO.
Primary Outcome Measure Information:
Title
Decline in ovarian reserve.
Description
Decline rate of AMH levels before and 6 months after surgery.
Time Frame
Up to 6 months.
Secondary Outcome Measure Information:
Title
Sonographic decline in ovarian volume
Description
Decline rate of ovarian volume before and 6 months after surgery.
Time Frame
Up to 6 months
Title
Sonographic decline in ovarian antral follicle count
Description
Decline rate of ovarian antral follicle count before and 6 months after surgery.
Time Frame
Up to 6 months
Title
Changes in FSH levels
Description
Changes in FSH levels before and 6 months after surgery.
Time Frame
Up to 6 months.
Title
Changes in LH levels
Description
Changes in LH levels before and 6 months after surgery.
Time Frame
Up to 6 months
Title
Changes in Progesterone levels
Description
Changes in Progesterone levels before and 6 months after surgery.
Time Frame
Up to 6 months
Title
Changes in E2 levels
Description
Changes in E2 levels before and 6 months after surgery.
Time Frame
Up to 6 months
Title
Number of antral follicles in the cyst removed from the ovary.
Description
Number of antral follicles in the cyst removed from the ovary as seen utilizing light microscopy.
Time Frame
Up to 6 months.

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female patients with operable ovarian cysts with clear indication for surgery.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roy Lauterbach, MD
Organizational Affiliation
Rambam Health Care Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam health care campus
City
Haifa
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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