Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2011-01
Study information
Scientific title
A prospective, randomised control trial of the effect of bag extraction in the prophylaxis of wound infection in laparoscopic cholecystectomy
Acronym
Study hypothesis
The use of bag to extract specimen during laparoscopic cholecystectomy will diminish the rate of wound infection on wound trocar site.
Ethics approval
Comité de Etica Investigació Clinica, January 2011, Ref: 2010-Parés Study
Study design
Single blind randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Choleitiasis / Laparoscopic cholecystectomy
Intervention
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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Surgical site infection
Secondary outcome measures
1. Port site complications (hernia)
2. Economic analysis
Overall trial start date
01/01/2011
Overall trial end date
31/12/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. Adult patients
2. Elective surgery of laparoscopic cholecystectomy
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200
Participant exclusion criteria
1. Open specimen intraoperatively
2. Acute cholecistitys finding intraoperatively
Recruitment start date
01/01/2011
Recruitment end date
31/12/2012
Locations
Countries of recruitment
Spain
Trial participating centre
Parc Sanitari sant Joan de Déu
Sant Boi de Llobregat (Barcelona)
08830
Spain
Sponsor information
Organisation
Saint John of God Health Park (Parc sanitari sant Joan de Deu) (Spain)
Sponsor details
c/o David Parés Md
PhD
Department of Surgery
C/ Cami vell colonia 25
Barcelona
08830
Spain
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Saint John of God Health Park (Parc sanitari Sant Joan de Deu) (Spain)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary