Comparing titanium-coated lightweight mesh versus medium-weight composite mesh for laparoscopic hernia repair
| ISRCTN | ISRCTN88233610 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88233610 |
| Secondary identifying numbers | N/A |
- 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
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
Scientific
Primo de Rivera 7, 5ºD
Murcia
30008
Spain
Study information
| Study design | Single-blind randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient 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 | 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 study start date | 01/01/2005 |
| Completion date | 30/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
30008
Spain
Sponsor information
Hospital/treatment centre
Marques de los Velez s/n
Murcia
30008
Spain
"ROR" |
https://ror.org/00cfm3y81 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
13/10/2016: Plain English summary added.
