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
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 patients 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
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