Condition category
Digestive System
Date applied
27/09/2011
Date assigned
07/10/2011
Last edited
13/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
A hernia occurs when an internal part of the body pushes through a weakness in the muscle or surrounding tissue wall. An incisional hernia is a type of hernia caused by an incompletely-healed surgical wound. It has become standard practice to use a mesh in hernia surgery. In recent years a new generation of meshes has been developed which have bigger pores with a lower weight or density, which are classified as heavyweight, medium-weight or lightweight. The aim of this study is to test a new lightweight mesh with titanium, which seems to have certain advantages as it provokes a less pronounced foreign body reaction compared with identical meshes lacking a titanium coating.

Who can participate?
Patients with an incisional hernia who are at least 18 years old

What does the study involve?
Participants are randomly allocated into one of two groups. Both groups undergo laparoscopic hernia repair (keyhole surgery), with one group receiving a titanium-coated mesh while the other group receives a collagen-polyester composite mesh. Pain, hernia recurrence analgesic (painkiller) consumption, and time taken to return to everyday activities are measured in both groups.

What are the possible benefits and risks of participating?
The use of lightweight meshes in hernia repair could have beneficial effects on quality of life (less pain, less use of analgesics and faster return to work).

Where is the study run from?
Morales Meseguer University Hospital (Spain)

When is the study starting and how long is it expected to run for?
January 2005 to December 2008

Who is funding the study?
Morales Meseguer University Hospital (Spain)

Who is the main contact?
Prof. Alfredo Moreno-Egea

Trial website

Contact information

Type

Scientific

Primary contact

Prof Alfredo Morno-Egea

ORCID ID

Contact details

Primo de Rivera 7
5ºD
Murcia
30008
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Randomized clinical trial of laparoscopic hernia repair comparing titanium-coated lightweight mesh versus mediumweight composite mesh

Acronym

Mesh Trial

Study hypothesis

The use of lightweight meshes in incisional hernia repair could have beneficial effects on quality of life.

Ethics approval

Ethics Committee of Morales Meseguer Hospital, 07/08/2004

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

Incisional hernia

Intervention

Group A: laparoscopic hernia repair with lightweight (titanium-coated). Patients n=51
Group B: laparoscopic hernia repair with heavyweight (collagen-polyester composite), patients n=51

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

1. Pain
1.1. Acute pain, defined as pain reported by a patient in the first 6 months after operation
1.2. Chronic pain, defined as pain that persisted for more than 12 months
1.3. Pain scores on a 10-cm visual analogue scale (VAS) were measured from 0 (no pain) to 10 (unbearable pain)
2. Recurrence, confirmed by clinical examination and computerised tomography (CT)

Secondary outcome measures

1. Morbidity
2. Operating time (minutes)
3. Hospital stay (days)
4. Need for oral analgesia (days)
5. The time it took to return to everyday activity (days). This period was defined as the time needed to be able to perform household activities, drive or walk painlessly. An increased analgesic requirement was defined as an analgesic intake which lasted for more than one day.

Overall trial start date

01/01/2005

Overall trial end date

30/12/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients who were at least 18 years old and diagnosed at the Abdominal Wall Unit of Morales Meseguer University Hospital of Murcia with an incisional hernia
1.1. In this study, incisional hernia was defined as any midline abdominal wall gap with a bulge in the area of a postoperative scar perceptible or palpable by clinical examination and imaging (localized between the xiphoid and pubic bone)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150

Participant exclusion criteria

1. Patients with non-midline hernias and a fascial defect greater than 10cm
2. Patients with incisional hernias repaired with a synthetic mesh
3. Those receiving corticosteroid therapy, radiotherapy or chemotherapy
4. Concurrent neoplasms
5. Proven mental illness or other circumstances that might compromise the patient’s cooperation as well as those who refused to give informed consent

Recruitment start date

01/01/2005

Recruitment end date

30/12/2008

Locations

Countries of recruitment

Spain

Trial participating centre

Primo de Rivera 7, 5ºD
Murcia
30008
Spain

Sponsor information

Organisation

Morales Meseguer Hospital (Spain)

Sponsor details

Marques de los Velez s/n
Murcia
30008
Spain

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Morales Meseguer Hospital (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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

13/10/2016: Plain English summary added.