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ISRCTN
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ISRCTN41994541
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ClinicalTrials.gov identifier
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Public title
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The Impact of Fibrin fixation of macroporous mesheS in TransAbdominal PrePeritoneal hernia repair
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Scientific title
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Acronym
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FSTAPP
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Serial number at source
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CT1
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Study hypothesis
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Reduction of postoperative pain and improved quality of life due to the use of atraumatic mesh fixation with a tissue sealant.
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Lay summary
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Ethics approval
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Granted by local ethics committee (Ethikkommission der Stadt Wien) on the 30th June 2006 (ref: EK 06-019-0306).
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Study design
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Prospective, randomised controlled trial
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Countries of recruitment
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Austria
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Disease/condition/study domain
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Primary unilateral- and bilateral inguinal hernia
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Participants - inclusion criteria
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1. Age between 18 and 70 years
2. Primary uni- and bilateral inguinal hernia
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Participants - exclusion criteria
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1. Unwilling to participate or no insight in purpose of the study
2. Not fluent in the German language
3. Pregnancy
4. Chronic condition/disease associated with permanent pain
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Anticipated start date
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01/05/2006
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Anticipated end date
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01/05/2009
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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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100
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Interventions
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Transabdominal laparoscopic inguinal hernia repair in general anaesthesia. The operation is a standard procedure.
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Primary outcome measure(s)
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Quality of Life assessed with the 36-item Short Form questionaire (SF-36) and pain assessed with the Visual Analoge Scale (VAS).
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Secondary outcome measure(s)
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Recurrences, postoperative complications assessed by clinical examination and ultrasound.
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Sources of funding
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Ludwig Boltzmann Institute for Traumatology, Cluster for Tissue Regeneration (Austria)
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Trial website
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Publications
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Papers with direct influence on this protocol:
1. http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=11141220
2. http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=16424986
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Contact name
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Dr
Rene
Fortelny
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Address
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2nd Department of Surgery
Wilhelminenspital
Montleartstr. 37
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City/town
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Vienna
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Zip/Postcode
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1200
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Country
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Austria
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Tel
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+43 (0)14 915 00
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Fax
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+43 (0)14 915 04209
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Email
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rene.fortelny@wienkav.at
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Sponsor
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Ludwig Boltzmann Institute for Traumatology (Austria)
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Address
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Donaueschingenstr. 13
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City/town
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Vienna
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Zip/Postcode
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1200
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Country
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Austria
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Tel
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+43 (0)13 311 0464
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Fax
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+43 (0)13 311 0460
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Email
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office@lbitrauma.org
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Sponsor website:
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http://www.lbitrauma.org/
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Date applied
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21/03/2007
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Last edited
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13/08/2007
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Date ISRCTN assigned
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13/08/2007
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