Condition category
Digestive System
Date applied
10/10/2012
Date assigned
03/12/2012
Last edited
08/06/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr David Parés

ORCID ID

Contact details

Parc Sanitari Sant Joan de Déu
C/ Cami Vell de la colonia 25
Sant Boi de Llobregat (Barcelona)
08830
Spain

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

http://www.pssjd.org/ca-es/Paginas/default.aspx

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

Publication citations

Additional files

Editorial Notes

08/06/2017: Plain English summary added. 16/05/2016: Publication reference added.