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ISRCTN
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ISRCTN11368235
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DOI
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10.1186/ISRCTN11368235
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Is inguinal hernia repair possible with glue?
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Scientific title
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Inguinal hernioplasty: tissue adhesive versus sutures - A randomized clinical trial
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Acronym
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N/A
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Serial number at source
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14186
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Study hypothesis
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Is the adhesive tissue an alternative to the sutures for the inguinal hernioplasty? The use of tissue adhesives can be an alternative to suture fixation of the mesh, but their experience is very limited.
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Lay summary
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Lay summary under review 2
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Ethics approval
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Ethic committee of Morales Meseguer University Hospital, 17/12/2006
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Study design
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Randomized prospective clinical trial
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Countries of recruitment
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Spain
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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. Patients with inguinal hernia not complicated
2. Patients (male and female) who were at least 18 years old and presented at the Abdominal Wall Unit of Morales Meseguer University Hospital of Murcia with a diagnosis of an inguinal hernia
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Participants - exclusion criteria
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Complicated hernias, bilateral and recurrent hernias
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Anticipated start date
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01/01/2007
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Anticipated end date
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30/12/2011
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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120
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Interventions
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Group 1 Lichtenstein operation (mesh fixed with sutures) and Group 2 mesh fixed with glue.
The synthetic adhesive is n-hexyl-á-cyanoacrylate
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Primary outcome measure(s)
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Pain and recurrence. Patients were assessed for pain at 7 days, 1, 6 and 12 months using a visual analogue scale with a range from 0-10, and were examined clinically for recurrence at 2 year after surgery.
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Secondary outcome measure(s)
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1. Operative time
2. Analgesic consumption
3. Hematoma
4. Infection
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Sources of funding
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Medical Canada (Spain)
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Trial website
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Publications
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Contact name
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Prof
Alfredo
Moreno-Egea
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Address
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Primo de Rivera 7, 5ºD
30008. Murcia
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City/town
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Murcia
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Zip/Postcode
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30008
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Country
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Spain
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Sponsor
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Medical Canada (Spain)
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Address
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Poligono Industrial
San Gines
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City/town
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Murcia
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Zip/Postcode
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30500
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Country
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Spain
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Date applied
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09/01/2013
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Last edited
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29/01/2013
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Date ISRCTN assigned
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29/01/2013
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