Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Version 2.0
Study information
Scientific title
Randomised controlled trial of transnasal oesophagoscopy versus standard care for patients presenting with throat symptoms
Acronym
TOVSC
Study hypothesis
The availability of transnasal oesophagoscopy in secondary care clinics for patients with throat symptoms results in a reduction in overall patient pathway time, reduced adverse events, an improved cost-benefit profile and is viewed as preferable by patients.
Ethics approval
Gloucestershire Research Ethics Committee, 08/12/2008, ref: 07/H0105/79
Study design
Randomised controlled open-label clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
Throat symptoms
Intervention
Control arm: Standard care
Intervention arm: Otolaryngologist is able to us a trans-nasal oesophagoscope to evaluate patient in addition to all other investigations routinely at his or her disposal in the otolaryngology and other hospital departments
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Process time, measured from the date of first presentation to the ENT clinic. The process will be said to have ended when the patient has been informed face-to-face of their definitive diagnosis. At this point most patients will be referred back to their general practitioner, or will enter a new pathway, such as treatment for head and neck cancer.
Secondary outcome measures
1. Minor adverse events
2. Major adverse events
3. Cost to:
3.1. Health care service
3.2. The patient
3.3. Society, calculated using the human capital approach
4. Quality of life
5. Cost-effectiveness
Overall trial start date
01/11/2009
Overall trial end date
01/12/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients referred to secondary care Ear, Nose and Throat (ENT) services at recruiting centres with throat symptoms
2. Aged 18 years or older
3. Specific symptoms
3.1. Globus pharyngeus
3.2. Dysphagia
3.3. Odynophagia
3.4. Pain in throat
3.5. Foreign body sensation
3.6. Blood stained sputum
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50 in each arm
Participant exclusion criteria
1. Patients unable to provide informed consent
2. Patients with large neck mass, raising a strong suspicion that the patient is suffering from a head and neck cancer
Recruitment start date
01/11/2009
Recruitment end date
01/12/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal National Throat Nose and Ear Hospital
London
WC1X 8DA
United Kingdom
Sponsor information
Organisation
Royal Free Hampstead NHS Trust (UK)
Sponsor details
Royal Free Hospital
Pond Street
London
NW3 2QG
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
Pentax UK Limited (UK) - funding analysis; analysis is being completed independantly by the Courtyard Group.
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