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ISRCTN
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ISRCTN38095251
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DOI
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10.1186/ISRCTN38095251
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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The effect of bag extraction in the prophylaxis of wound infection in laparoscopic cholecystectomy
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Scientific title
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A prospective, randomised control trial of the effect of bag extraction in the prophylaxis of wound infection in laparoscopic cholecystectomy
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Acronym
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N/A
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Serial number at source
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2011-01
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Study hypothesis
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The use of bag to extract specimen during laparoscopic cholecystectomy will diminish the rate of wound infection on wound trocar site.
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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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Comité de Etica Investigació Clinica, January 2011, Ref: 2010-Parés Study
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Study design
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Single blind randomized controlled 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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Choleitiasis / Laparoscopic cholecystectomy
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Participants - inclusion criteria
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1. Adult patients
2. Elective surgery of laparoscopic cholecystectomy
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Participants - exclusion criteria
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1. Open specimen intraoperatively
2. Acute cholecistitys finding intraoperatively
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Anticipated start date
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01/01/2011
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Anticipated end date
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31/12/2012
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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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200
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Interventions
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The use of bag to extract specimen (gallblader) after operation versus do not use the bag (standard protocol).
At the end of surgical intervention and after randomization, a bag will be use to extract specimen for the umbilicus port site wound.
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Primary outcome measure(s)
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Surgical site infection
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Secondary outcome measure(s)
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1. Port site complications (hernia)
2. Economic analysis
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Sources of funding
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Saint John of God Health Park (Parc sanitari Sant Joan de Deu) (Spain)
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Trial website
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Publications
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Contact name
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Dr
David
Parés
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Address
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Parc Sanitari sant Joan de Déu
C/ Cami Vell de la colonia 25
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City/town
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Sant Boi de Llobregat (Barcelona)
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Zip/Postcode
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08830
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Country
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Spain
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Sponsor
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Saint John of God Health Park (Parc sanitari sant Joan de Deu) (Spain)
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Address
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c/o David Parés Md, PhD
Department of Surgery
C/ Cami vell colonia 25
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City/town
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Barcelona
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Zip/Postcode
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08830
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Country
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Spain
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Sponsor website:
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http://www.pssjd.org/ca-es/Paginas/default.aspx
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Date applied
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10/10/2012
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Last edited
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03/12/2012
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Date ISRCTN assigned
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03/12/2012
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