The Affect of Hemostasis Technique During Laparoscopic Ovarian Cystectomy on Future Fertility
NCT ID: NCT03109964
Last Updated: 2022-10-26
Study Results
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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COMPLETED
NA
127 participants
INTERVENTIONAL
2018-11-20
2022-08-01
Brief Summary
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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.
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Hemostasis with bipolar coagulation
Patients undergoing laparoscopic ovarian cystectomy with bipolar coagulation hemostasis.
Bipolar coagulation forceps (ETHICON inc.)
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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
44 Years
FEMALE
No
Sponsors
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Rambam Health Care Campus
OTHER
Responsible Party
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ROY LAUTERBACH MD
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
Countries
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Other Identifiers
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0232-17-RMB
Identifier Type: -
Identifier Source: org_study_id
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