Randomised controlled trial: groin hernia repair with titanium coated mesh compared to prolene mesh
| ISRCTN | ISRCTN36979348 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36979348 |
| Secondary identifying numbers | N/A |
- Submission date
- 13/11/2007
- Registration date
- 14/01/2008
- Last edited
- 15/09/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Angelica Koch
Scientific
Scientific
Djurgardsg 58
Linkoping
582 29
Sweden
Study information
| Study design | Randomised controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Lightweight titanium-coated mesh gives a faster time of convalescence and return to work and normal activity compared to standard heavyweight mesh prolene. |
| Ethics approval(s) | Ethics approval received from the Ethics Committee of (Forskningsetikkommitten) University Hospital on the 3rd December 2005 (ref: 03-428). |
| Health condition(s) or problem(s) studied | Primary unilateral inguinal hernia in men |
| Intervention | A tension free repair using the Lichtenstein technique is performed, with local anaesthetics administered into the wound peroperatively.The basic principle is one unit, one surgeon, one method, and two meshes (randomised): 1. Lightweight titanium-coated mesh 2. Heavyweight prolene mesh All operations are done in the same outpatient clinic under general anaesthesia. The surgeon is highly specialised, performing more than 500 hernia repairs a year and has over 30 years of operative experience. |
| Intervention type | Other |
| Primary outcome measure | Short-term convalescence, is evaluated by using a validated questionnaire in form of a diary assessing postoperative symptoms and recovery at rest and some other activities, which the patients after completion return by mail. It includes Visual Analogue Scales (VAS) ranging from 0 (no pain) to 100 mm (worst imaginable pain) to estimate preoperative pain, and experienced pain on day 1, 2, 3, 4, and 8 weeks after the operation. It also includes questions about time to return to work and normal activity. |
| Secondary outcome measures | One-year follow-up results: 1. Testicular atrophy, recurrence and chronic pain and discomfort (VAS) are assessed at the clinical visit 2. Quality of life is assessed using the Short Health Scale (SHS), regarding the intensity of symptoms, how much worries they cause and how they affect daily life and general well-being |
| Overall study start date | 01/02/2004 |
| Completion date | 30/06/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 300 |
| Key inclusion criteria | Men in the age from 20 to 75 years with an elective Lichtenstein repair of a unilateral primary inguinal hernia were eligible to participate in the study. The patients were recruited and had their surgery in a clinic specialised in elective out-patient operations. |
| Key exclusion criteria | Patients who were unable to walk 500 metres or unlikely to participate in the follow up (for example owing to language difficulties) were excluded. |
| Date of first enrolment | 01/02/2004 |
| Date of final enrolment | 30/06/2006 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Djurgardsg 58
Linkoping
582 29
Sweden
582 29
Sweden
Sponsor information
State Health Care in Ostergotland County (Landstingen i Ostergotland) (Sweden)
Government
Government
S:t Larsg 49 B
Linkoping
582 24
Sweden
| Phone | +46 (0)13 222000 |
|---|---|
| landstinget@lio.se | |
| Website | http://www.lio.se |
Funders
Funder type
Government
State Health Care in Ostergotland County (Landstingen i Ostergotland) (Sweden)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/10/2008 | Yes | No |
