Condition category
Surgery
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
13/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Tristram Hugh John Lesser

ORCID ID

Contact details

AintreeTrust
University Hospital Aintree
Lower Lane
L9 7AL
Liverpool
L9 7AL
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0025157091

Study information

Scientific title

Randomised pilot study of primary re-innervation of the larynx in patients undergoing vagal resection

Acronym

Study hypothesis

To perform a pilot trial to assess whether dynamic methods of vagal nerve repair produce superior functional results to static repair techniques.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled pilot trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Surgery: Vagal resection

Intervention

Pilot study

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/12/2004

Overall trial end date

01/12/2008

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

10 patients

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/12/2004

Recruitment end date

01/12/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

AintreeTrust
Liverpool
L9 7AL
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Aintree Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes