Prevalence of Port Site Hernia After Mesh Placement in Laparoscopic Cholecystectomy.
NCT ID: NCT03495557
Last Updated: 2022-03-23
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
PHASE4
200 participants
INTERVENTIONAL
2018-01-01
2021-09-01
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
DOUBLE
Study Groups
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Control
Simple closure
Control
Fascial closure with simple polydioxanone suture 2/0 stitches
Experimental
Simple closure + mesh
Experimental
Onlay polypropylene mesh placement (MN mesh)
Interventions
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Control
Fascial closure with simple polydioxanone suture 2/0 stitches
Experimental
Onlay polypropylene mesh placement (MN mesh)
Eligibility Criteria
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Inclusion Criteria
* Laparoscopic cholecystectomy
* Emergent/elective
* ≥2 risk factors: diabetes mellitus, age ≥70 years, BMI ≥30, fascial enlargement
Exclusion Criteria
* Emergent re intervention
* Immunosuppression
* Umbilical hernia
18 Years
ALL
No
Sponsors
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Hospital de Mataró
OTHER
Responsible Party
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Ana Ciscar
MD
Principal Investigators
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Ana Ciscar, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital de Mataró
Locations
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Hospital de Mataró
Mataró, Barcelona, Spain
Countries
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References
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Ciscar A, Sanchez-Saez E, Vila Tura M, Ruiz de Leon P, Gomez Pallares M, Troyano Escribano D, Abadal Prades M, Mans Muntwyler E, Pereira JA, Badia JM. Assessment of the effectiveness of a polypropylene onlay mesh in the prevention of laparoscopic trocar-site incisional hernia in high-risk patients. A randomized clinical trial. Hernia. 2024 Dec;28(6):2187-2194. doi: 10.1007/s10029-024-03124-7. Epub 2024 Aug 29.
Other Identifiers
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PORT SITE HERNIA
Identifier Type: -
Identifier Source: org_study_id
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