Randomised pilot study of primary re-innervation of the larynx in patients undergoing vagal resection
| ISRCTN | ISRCTN85646253 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85646253 |
| Protocol serial number | N0025157091 |
| Sponsor | Department of Health |
| Funders | Aintree Hospitals NHS Trust (UK), NHS R&D Support Funding |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled pilot trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | All |
| Target sample size at registration | 10 |
| 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
- United Kingdom
- England
Study participating centre
AintreeTrust
Liverpool
L9 7AL
United Kingdom
L9 7AL
United Kingdom
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 |
