A prospective randomised controlled trial of Vypro II and TiMesh in inguinal hernia repair using the total extraperitoneal endoscopic approach
| ISRCTN | ISRCTN96288558 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN96288558 |
| Secondary identifying numbers | N/A |
- Submission date
- 13/09/2005
- Registration date
- 24/11/2005
- Last edited
- 14/09/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Jan Kuester
Scientific
Scientific
Schoenenwerdstrasse 1
Schlieren
8952
Switzerland
| jrkuester@gmx.net |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | No difference in inguinal pain and discomfort between TiMesh and Vypro II used in inguinal hernia repair. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Inguinal hernia. |
| Intervention | Total endoscopic extraperitoneal hernia repair with either TiMesh or Vypro II. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Inguinal pain and discomfort at 6 weeks and 2 years. |
| Secondary outcome measures | 1. Hernia recurrence 2. Complications 3. Quality of life |
| Overall study start date | 01/01/2004 |
| Completion date | 01/06/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target number of participants | 350 |
| Key inclusion criteria | 1. Male gender 2. Primary bilateral hernia 3. Recurrent unilateral hernia 4. Primary unilateral hernia 5. Age >18 years 6. Consent to the study |
| Key exclusion criteria | 1. Female gender 2. Change of diagnosis during operation (e.g. femoral hernia) 3. Change of operative procedure during operation (e.g. TAPP) |
| Date of first enrolment | 01/01/2004 |
| Date of final enrolment | 01/06/2006 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Schoenenwerdstrasse 1
Schlieren
8952
Switzerland
8952
Switzerland
Sponsor information
Spital Limmattal, Department of Surgery (Switzerland)
Hospital/treatment centre
Hospital/treatment centre
Urdorferstrasse 100
Schlieren
8952
Switzerland
"ROR" |
https://ror.org/0591e2567 |
|---|
Funders
Funder type
Hospital/treatment centre
Department of Surgery, Spital Limmattal (Switzerland)
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 |
