Prevention of Umbilical Port-site Hernia After Laparoscopic Cholecystectomy Using a Prosthetic Mesh Versus Simple Suture
NCT ID: NCT01802229
Last Updated: 2013-03-01
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
PHASE3
106 participants
INTERVENTIONAL
2011-01-31
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Suture
Umbilical port-site closure with simple suture of the fascia.
Fascial suture
The port-site hole is closed with simple suture of the fascia
Prophylactic mesh
Umbilical port-site closure with mesh placement
Prophylactic mesh placement
Placement of a Omega 3 mesh, fixed to the border of the fascia
Interventions
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Prophylactic mesh placement
Placement of a Omega 3 mesh, fixed to the border of the fascia
Fascial suture
The port-site hole is closed with simple suture of the fascia
Eligibility Criteria
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Inclusion Criteria
* BMI \> 30 Kg/m2
* Diabetes mellitus
* Lung disease
* Elective laparoscopic cholecystectomy
Exclusion Criteria
* Previous laparotomy
* Conversion to open procedure
* Loss during the follow up
18 Years
90 Years
ALL
No
Sponsors
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Hospital General Universitario Elche
OTHER
Responsible Party
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Jaime Ruiz-Tovar, MD, PhD
Professor
Locations
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Hospital general Universitario de Elche
Elche, Alicante, Spain
Countries
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Other Identifiers
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2013-002
Identifier Type: -
Identifier Source: org_study_id
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