Condition category
Digestive System
Date applied
16/11/2015
Date assigned
01/12/2015
Last edited
16/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 measures

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

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

www.medicalcanada.es

Funders

Funder type

University/education

Funder name

Universidad de Murcia

Alternative name(s)

University of Murcia

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes