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

NCT03109964 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2022-10-26

No results posted yet for this study

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.

Conditions

  • Cyst Ovary

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.

Sponsors & Collaborators

  • Rambam Health Care Campus

    lead OTHER

Principal Investigators

  • Roy Lauterbach, MD · Rambam Health Care Campus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
44 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-20
Primary Completion
2021-03-31
Completion
2022-08-01

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03109964 on ClinicalTrials.gov