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The effect of bag extraction in the prophylaxis of wound infection in laparoscopic cholecystectomy
ISRCTN ISRCTN38095251
DOI 10.1186/ISRCTN38095251
ClinicalTrials.gov identifier
EudraCT number
Public title The effect of bag extraction in the prophylaxis of wound infection in laparoscopic cholecystectomy
Scientific title A prospective, randomised control trial of the effect of bag extraction in the prophylaxis of wound infection in laparoscopic cholecystectomy
Acronym N/A
Serial number at source 2011-01
Study hypothesis The use of bag to extract specimen during laparoscopic cholecystectomy will diminish the rate of wound infection on wound trocar site.
Lay summary Lay summary under review 2
Ethics approval Comité de Etica Investigació Clinica, January 2011, Ref: 2010-Parés Study
Study design Single blind randomized controlled trial
Countries of recruitment Spain
Disease/condition/study domain Choleitiasis / Laparoscopic cholecystectomy
Participants - inclusion criteria 1. Adult patients
2. Elective surgery of laparoscopic cholecystectomy
Participants - exclusion criteria 1. Open specimen intraoperatively
2. Acute cholecistitys finding intraoperatively
Anticipated start date 01/01/2011
Anticipated end date 31/12/2012
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 200
Interventions 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.
Primary outcome measure(s) Surgical site infection
Secondary outcome measure(s) 1. Port site complications (hernia)
2. Economic analysis
Sources of funding Saint John of God Health Park (Parc sanitari Sant Joan de Deu) (Spain)
Trial website
Publications
Contact name Dr  David  Parés
  Address Parc Sanitari sant Joan de Déu
C/ Cami Vell de la colonia 25
  City/town Sant Boi de Llobregat (Barcelona)
  Zip/Postcode 08830
  Country Spain
Sponsor Saint John of God Health Park (Parc sanitari sant Joan de Deu) (Spain)
  Address c/o David Parés Md, PhD
Department of Surgery
C/ Cami vell colonia 25
  City/town Barcelona
  Zip/Postcode 08830
  Country Spain
  Sponsor website: http://www.pssjd.org/ca-es/Paginas/default.aspx
Date applied 10/10/2012
Last edited 03/12/2012
Date ISRCTN assigned 03/12/2012
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