Plain English Summary
Background and study aims
Laparoscopic (keyhole) cholecystectomy is a surgical procedure where several small cuts (incisions) are made in the abdomen to access and remove the gallbladder. There is a lack of evidence about whether using a bag to extract the gallbladder reduces surgical site infection. Therefore the aim of this study is to assess the effectiveness of bag extraction of the gallbladder at preventing surgical site infection.
Who can participate?
Adult patients undergoing laparoscopic cholecystectomy
What does the study involve?
Participants are randomly allocated to have their gallbladder removed either using a bag or without using a bag. Surgical site infections, complications (hernia) and costs are compared between the two groups.
What are the possible benefits and risks of participating?
The use of a bag may reduce the chance of a surgical site infection. No side effects are expected.
Where is the study run from?
Parc Sanitari Sant Joan de Déu (Spain)
When is the study starting and how long is it expected to run for?
January 2011 to December 2012
Who is funding the study?
Parc Sanitari Sant Joan de Déu (Spain)
Who is the main contact?
Dr David Parés
Trial website
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 to request a patient information sheet
Condition
Choleitiasis/laparoscopic cholecystectomy
Intervention
The use of bag to extract specimen (gallbladder) after operation versus not using the bag (standard protocol).
At the end of the surgical intervention and after randomization, a bag will be used to extract the specimen for the umbilicus port site wound.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
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 (if study stopped)
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 cholecystitis 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
Basic results (scientific)
Publication list
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27177957