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ISRCTN
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ISRCTN96288558
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ClinicalTrials.gov identifier
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Public title
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A prospective randomised controlled trial of Vypro II and TiMesh in inguinal hernia repair using the total extraperitoneal endoscopic approach
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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No difference in inguinal pain and discomfort between TiMesh and Vypro II used in inguinal hernia repair.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Switzerland
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Disease/condition/study domain
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Inguinal hernia.
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Participants - inclusion criteria
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1. Male gender
2. Primary bilateral hernia
3. Recurrent unilateral hernia
4. Primary unilateral hernia
5. Age >18 years
6. Consent to the study
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Participants - exclusion criteria
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1. Female gender
2. Change of diagnosis during operation (e.g. femoral hernia)
3. Change of operative procedure during operation (e.g. TAPP)
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Anticipated start date
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01/01/2004
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Anticipated end date
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01/06/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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350
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Interventions
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Total endoscopic extraperitoneal hernia repair with either TiMesh or Vypro II.
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Primary outcome measure(s)
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Inguinal pain and discomfort at 6 weeks and 2 years.
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Secondary outcome measure(s)
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1. Hernia recurrence
2. Complications
3. Quality of life
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Sources of funding
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Department of Surgery, Spital Limmattal (Switzerland)
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Trial website
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Publications
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Contact name
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Mr
Jan
Kuester
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Address
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Schoenenwerdstrasse 1
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City/town
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Schlieren
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Zip/Postcode
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8952
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Country
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Switzerland
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Email
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jrkuester@gmx.net
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Sponsor
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Spital Limmattal, Department of Surgery (Switzerland)
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Address
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Urdorferstrasse 100
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City/town
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Schlieren
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Zip/Postcode
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8952
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Country
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Switzerland
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Date applied
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13/09/2005
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Last edited
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14/09/2009
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Date ISRCTN assigned
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24/11/2005
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