Plain English Summary
Background and study aims
Laparoscopy is a type of surgery that allows a surgeon to access the inside of the body without having to make large incisions in the skin. The arrival of laparoscopy could be regarded as the biggest change in surgical techniques this century. However, there is a negative side to this new approach, such as a new kind of hernia, the trocar-site hernia. A hernia is a weakness or split in the muscle wall of the abdomen which allows the abdominal contents (usually some part of the intestine) to bulge out. With the increasing use of laparoscopic surgery the problem of this new type of hernia will increase too. The surgical placement of a prophylactic (preventive) mesh may help to prevent trocar-site hernia. The aim of this study is to find out whether it is possible to prevent trocar-site hernia after laparoscopic cholecystectomy by placing a prophylactic mesh.
Who can participate?
Patients aged 20-70 undergoing laparoscopic cholecystectomy (gallbladder removal) for cholelitiasis (gallstones).
What does the study involve?
Patients are randomly allocated to either receive a prophylactic mesh or to not receive a mesh during their operation.
What are the possible benefits and risks of participating?
The patients who receive the mesh may be at risk of seroma (collection of fluid) or wound infection at the mesh site. The patients who do not receive the mesh may be at risk of hernia.
Where is the study run from?
La Vega Hospital (Spain).
When is the study starting and how long is it expected to run for?
January 2013 to December 2016.
Who is funding the study?
Universidad de Murcia (Spain).
Who is the main contact?
Prof Alfredo Moreno-Egea
moreno-egea@ono.com
Trial website
Contact information
Type
Scientific
Primary contact
Prof Alfredo Moreno-Egea
ORCID ID
Contact details
Avda Primo de Rivera 7
5ºD
Murcia
30008
Spain
+ 34(0) 639 66 21 13
moreno-egea@ono.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Prevention of the trocar-site hernia with prophylactic mesh: a randomized clinical trial
Acronym
Study hypothesis
The trocar-site hernia is a new complication in laparoscopic surgery which is becoming increasingly prevalent. Thus, the search for an efficient method of prophylaxis should be prioritized.
The aim of this study is to find out whether it is possible to prevent trocar-site hernia (umbilical site) after laparoscopic cholecystectomy using a prophylactic mesh.
Ethics approval
Hospital General Universitario Morales Meseguer Ethics Committee, 01/01/2013
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Trocar-site hernia
Intervention
Patients were randomized on the day of surgery to receive either a prophylactic mesh in the umbilical trocar site (treatment group) or no treatment in the umbilical site (no treatment - control group).
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Recurrence rate at 1 year
Secondary outcome measures
1. Operative time
2. Morbidity (infection, seroma or chronic pain) at 1 month and 3 months
Overall trial start date
01/01/2013
Overall trial end date
30/12/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients undergoing surgery for symptomatic cholelitiasis
2. Age range 20-70 years
3. Male and female
4. American Society of Anesthesiology (ASA) classification of 3 or less
5. No co-morbidity cardiopulmonary, hepatic or renal impairment
6. Consent was given for surgery
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100 patients: two groups of 50 patients
Participant exclusion criteria
1. Patients with ASA higher than 3
2. Current malignant diseases
3. Proven mental illness or other circumstances that might compromise the patient’s cooperation in addition to those who refused to give informed consent
Recruitment start date
01/01/2015
Recruitment end date
30/12/2016
Locations
Countries of recruitment
Spain
Trial participating centre
La Vega Hospital
Murcia
30008
Spain
Sponsor information
Organisation
Medical Cañada (Spain)
Sponsor details
Calle Jubilo
S/N - Parcela 24 Nave C6
Poligono Industrial Oeste
San Ginés
Murcia
30820
Spain
Sponsor type
Industry
Website
Funders
Funder type
University/education
Funder name
Universidad de Murcia
Alternative name(s)
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
Spain
Results and Publications
Publication and dissemination plan
To be confirmed at a later date
Intention to publish date
30/06/2016
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list