The effect of bag extraction in the prophylaxis of wound infection in laparoscopic cholecystectomy
| ISRCTN | ISRCTN38095251 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38095251 |
| Secondary identifying numbers | 2011-01 |
- Submission date
- 10/10/2012
- Registration date
- 03/12/2012
- Last edited
- 08/06/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
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
Contact information
Scientific
Parc Sanitari Sant Joan de Déu
C/ Cami Vell de la colonia 25
Sant Boi de Llobregat (Barcelona)
08830
Spain
Study information
| Study design | Single-blind randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A prospective, randomised control trial of the effect of bag extraction in the prophylaxis of wound infection in laparoscopic cholecystectomy |
| Study objectives | The use of bag to extract specimen during laparoscopic cholecystectomy will diminish the rate of wound infection on wound trocar site. |
| Ethics approval(s) | Comité de Etica Investigació Clinica, January 2011, ref: 2010-Parés Study |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Surgical site infection |
| Secondary outcome measures | 1. Port site complications (hernia) 2. Economic analysis |
| Overall study start date | 01/01/2011 |
| Completion date | 31/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 200 |
| Key inclusion criteria | 1. Adult patients 2. Elective surgery of laparoscopic cholecystectomy |
| Key exclusion criteria | 1. Open specimen intraoperatively 2. Acute cholecystitis finding intraoperatively |
| Date of first enrolment | 01/01/2011 |
| Date of final enrolment | 31/12/2012 |
Locations
Countries of recruitment
- Spain
Study participating centre
08830
Spain
Sponsor information
Hospital/treatment centre
c/o David Parés MD, PhD
Department of Surgery
C/ Cami vell colonia 25
Barcelona
08830
Spain
| Website | http://www.pssjd.org/ca-es/Paginas/default.aspx |
|---|---|
"ROR" |
https://ror.org/02f3ts956 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2017 | Yes | No |
Editorial Notes
08/06/2017: Plain English summary added.
16/05/2016: Publication reference added.
