Comparison of transnasal oesophagoscopy versus standard care for patients presenting with throat symptoms

ISRCTN	ISRCTN68055393
DOI	https://doi.org/10.1186/ISRCTN68055393
Protocol serial number	Version 2.0
Sponsor	Royal Free Hampstead NHS Trust (UK)
Funder	Pentax UK Limited (UK) - funding analysis; analysis is being completed independantly by the Courtyard Group.

Submission date: 16/03/2010
Registration date: 23/08/2010
Last edited: 12/09/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Ear, Nose and Throat

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

Prof Martin Birchall
Scientific

Royal National Throat Nose and Ear Hospital
330 Gray's Inn Road
London
WC1X 8DA
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised controlled open-label clinical trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Randomised controlled trial of transnasal oesophagoscopy versus standard care for patients presenting with throat symptoms
Study acronym	TOVSC
Study objectives	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(s)	Gloucestershire Research Ethics Committee, 08/12/2008, ref: 07/H0105/79
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	01/12/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	50
Key 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
Key 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
Date of first enrolment	01/11/2009
Date of final enrolment	01/12/2010

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Royal National Throat Nose and Ear Hospital

London
WC1X 8DA
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

Editorial Notes

12/09/2016: No publications found, verifying study status with principal investigator.