Condition category
Ear, Nose and Throat
Date applied
16/03/2010
Date assigned
23/08/2010
Last edited
12/09/2016
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

Prof Martin Birchall

ORCID ID

Contact details

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

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

http://www.royalfree.org.uk/

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

Publication citations

Additional files

Editorial Notes

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