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

NCT ID: NCT03109964

Last Updated: 2022-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

127 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-20

Study Completion Date

2022-08-01

Brief Summary

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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

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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

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Cyst Ovary

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Hemostasis with bipolar coagulation

Patients undergoing laparoscopic ovarian cystectomy with bipolar coagulation hemostasis.

Group Type ACTIVE_COMPARATOR

Bipolar coagulation forceps (ETHICON inc.)

Intervention Type DEVICE

Hemostasis of the base of the ovarian cyst by utilization of a bipolar coagulation device.

Hemostasis with SURGIFLO

Patients undergoing laparoscopic ovarian cystectomy with SURGIFLO hemostasis.

Group Type EXPERIMENTAL

SURGIFLO hemostatic matrix (ETHICON inc.)

Intervention Type DEVICE

Hemostasis of the base of the ovarian cyst by utilization of a an absorbable gelatin based matrix known as SURGIFLO.

Interventions

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Bipolar coagulation forceps (ETHICON inc.)

Hemostasis of the base of the ovarian cyst by utilization of a bipolar coagulation device.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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ROY LAUTERBACH MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Roy Lauterbach, MD

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Locations

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Rambam health care campus

Haifa, , Israel

Site Status

Countries

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Israel

Other Identifiers

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0232-17-RMB

Identifier Type: -

Identifier Source: org_study_id

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