Comparing titanium-coated lightweight mesh versus medium-weight composite mesh for laparoscopic hernia repair

ISRCTN	ISRCTN88233610
DOI	https://doi.org/10.1186/ISRCTN88233610
Protocol serial number	N/A
Sponsor	Morales Meseguer Hospital (Spain)
Funder	Morales Meseguer Hospital (Spain)

Submission date: 27/09/2011
Registration date: 07/10/2011
Last edited: 13/10/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Prof Alfredo Morno-Egea
Scientific

Primo de Rivera 7, 5ºD
Murcia
30008
Spain

Study information

Primary study design	Interventional
Study design	Single-blind randomized controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Randomized clinical trial of laparoscopic hernia repair comparing titanium-coated lightweight mesh versus mediumweight composite mesh
Study acronym	Mesh Trial
Study objectives	The use of lightweight meshes in incisional hernia repair could have beneficial effects on quality of life.
Ethics approval(s)	Ethics Committee of Morales Meseguer Hospital, 07/08/2004
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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)
Key secondary outcome measure(s)	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.
Completion date	30/12/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	150
Key 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)
Key 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
Date of first enrolment	01/01/2005
Date of final enrolment	30/12/2008

Locations

Countries of recruitment

Spain

Study participating centre

Primo de Rivera 7, 5ºD

Murcia
30008
Spain

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

13/10/2016: Plain English summary added.