Randomised pilot study of primary re-innervation of the larynx in patients undergoing vagal resection
| ISRCTN | ISRCTN85646253 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85646253 |
| Secondary identifying numbers | N0025157091 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 13/08/2015
- 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 Tristram Hugh John Lesser
Scientific
Scientific
AintreeTrust
University Hospital Aintree
Lower Lane
L9 7AL
Liverpool
L9 7AL
United Kingdom
Study information
| Study design | Randomised controlled pilot 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 below to request a patient information sheet |
| Scientific title | Randomised pilot study of primary re-innervation of the larynx in patients undergoing vagal resection |
| Study objectives | To perform a pilot trial to assess whether dynamic methods of vagal nerve repair produce superior functional results to static repair techniques. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Vagal resection |
| Intervention | Pilot study |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/12/2004 |
| Completion date | 01/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | 10 patients |
| Key inclusion criteria | 10 patients aged 16 and over undergoing resection of tumors related to the skull base where interruption of the vagus nerve is necessary to achieve tumour clearance. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/12/2004 |
| Date of final enrolment | 01/12/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
AintreeTrust
Liverpool
L9 7AL
United Kingdom
L9 7AL
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Aintree Hospitals NHS Trust (UK)
No information available
NHS R&D Support Funding
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 |
