A double blind RCT of selective supraomohyoid neck dissection with/without level 2b for node negative oral cancer and resulting shoulder function

ISRCTN	ISRCTN22424487
DOI	https://doi.org/10.1186/ISRCTN22424487
Secondary identifying numbers	N0025177121

Submission date: 29/09/2006
Registration date: 29/09/2006
Last edited: 27/11/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Stanley Parikh
Scientific

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

Phone	+44 0151 529 5283
Email	sparikh@nhs.net

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A double blind RCT of selective supraomohyoid neck dissection with/without level 2b for node negative oral cancer and resulting shoulder function
Study objectives	The aim of the project is to compare patient derived and clinician rated morbidity, in terms of shoulder function, following a selective 1-3 level neck dissection in two groups of patients randomised for inclusion of level 2b in the neck and shoulder.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Cancer: Head and neck
Intervention	This will be a pilot study for a double blind randomised controlled trial. 60 patients requiring selective 1-3 level neck dissection as part of their overall treatment plan would be randomised as to whether they have a level 2b or not. Assessment will be at 3 points: baseline, six weeks post operatively and 6 months. There will be monitoring for 2 years using existing follow-up protocols for neck node recurrence. Assessment will include: neurophysiology examination, clinical examination, self-completed questionnaires.
Intervention type	Other
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/2006
Completion date	01/01/2009

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	60
Key inclusion criteria	1. Patients with previously untreated oral cancer arising from the floor of the mouth and anterior two thirds of tongue who are neck node negative both clinically and on MRI scan. 2. Requiring selective 1-3 level neck dissection as part of their overall treatment plan.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/2006
Date of final enrolment	01/01/2009

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

AintreeTrust

Liverpool
L9 7AL
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2012		Yes	No

Editorial Notes

27/11/2015: Publication reference added.