Long-term Follow-up of Incisional Hernia Repaired With Intraperitoneal Mesh
NCT ID: NCT00891254
Last Updated: 2012-10-31
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
PHASE1
80 participants
INTERVENTIONAL
2009-01-31
2012-07-31
Brief Summary
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The authors believe that the intraperitoneal repair performs better than the on-lay repair for incisional hernia.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1. Intraperitoneal repair
Patients with incisional hernia, 5 cm in diameter or with an area of 25 cm2, submitted to elective surgery
Implant of a prosthetic mesh
A prosthetic mesh will be implanted either intraperitoneally or in the on-lay (supra-fascial) position depending on the arm of the study
2. On-Lay repair
Patients with incisional hernia, with a diameter of 5 cm or an area of 25 cm2, submitted to elective surgery
Implant of a prosthetic mesh
A prosthetic mesh will be implanted either intraperitoneally or in the on-lay (supra-fascial) position depending on the arm of the study
Interventions
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Implant of a prosthetic mesh
A prosthetic mesh will be implanted either intraperitoneally or in the on-lay (supra-fascial) position depending on the arm of the study
Eligibility Criteria
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Inclusion Criteria
* First repair
* Older than 35 years of age and younger than 75 years of age
* Both genders
* Any BMI
* Only upper abdominal midline incisional hernias (supraumbilical)
* Patients submitted only to elective repair
Exclusion Criteria
* Emergency surgery
* Hernias with a diameter higher than 5 cm or more than 25 cm2 of area
* Lower midline abdominal incisional hernias
* Other hernias rather than midline incisional hernias
* Non-incisional hernias
35 Years
75 Years
ALL
No
Sponsors
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Cirujanos la Serena
OTHER
Responsible Party
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MARCELO A. BELTRAN, M.D.
DIGESTIVE SURGEON
Principal Investigators
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MARCELO A BELTRAN, M.D.
Role: PRINCIPAL_INVESTIGATOR
Hospital de La Serena
Locations
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Hospital de La Serena
La Serena, Coquimbo Region, Chile
Countries
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Other Identifiers
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HLS-2904009-03
Identifier Type: -
Identifier Source: org_study_id