Laparascopic Keyhole vs Sugarbaker Repair in Parastomal Hernia
NCT ID: NCT04187235
Last Updated: 2019-12-05
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
135 participants
OBSERVATIONAL
1997-01-01
2015-12-30
Brief Summary
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Detailed Description
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Summary Background Data: Two reviews of uncontrolled studies concluded that the Sugarbaker repair is superior to the Keyhole repair. The present study challenges the claim.
Methods: In two time periods 135 patients with a parastomal hernia were repaired with the Keyhole technique (74 patients, using a two-layer mesh of polypropylene and ePTFE with a self-cut slit, 1997- 2009) or the Sugarbaker technique (61 patients, using a coated polypropylene mesh, 2009-2015). The patients in the two groups matched with regard to age, gender, ASA score, colostomy or ileostomy hernia, previous repairs, size of fascial defect and simultaneous repair of a concurrent incisional hernia. Observation time was defined as time to recurrence, stoma re-siting, mesh removal, death, or last non-event visit
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Keyhole rapair
74 patients who undervent parastomal hernia repair with keyhole technique 1997-2009
Laparascopic repair of parastomal hernia
Laparascopic repair of parastomal hernia
Sugarbaker repair
61 patients who undervent parastomal henia repair a.m. Sugarbaker 2009-2015
Laparascopic repair of parastomal hernia
Laparascopic repair of parastomal hernia
Interventions
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Laparascopic repair of parastomal hernia
Laparascopic repair of parastomal hernia
Eligibility Criteria
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Exclusion Criteria
18 Years
ALL
No
Sponsors
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Aalborg University Hospital
OTHER
Responsible Party
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Vitaly Alexandrovich Gameza
MD
Principal Investigators
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Paul Wara, DMSc
Role: STUDY_CHAIR
Aarhus University Hospital
Locations
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Aarhus University Hospital
Aarhus, , Denmark
Countries
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Other Identifiers
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Keyhole vs Sugarbaker
Identifier Type: -
Identifier Source: org_study_id
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