Comparison of transnasal oesophagoscopy versus standard care for patients presenting with throat symptoms
| ISRCTN | ISRCTN68055393 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68055393 |
| Secondary identifying numbers | Version 2.0 |
- 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
Scientific
Royal National Throat Nose and Ear Hospital
330 Gray's Inn Road
London
WC1X 8DA
United Kingdom
Study information
| Study design | Randomised controlled open-label clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details below to request a patient 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 | 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 study start date | 01/11/2009 |
| Completion date | 01/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 50 in each arm |
| 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
- England
- United Kingdom
Study participating centre
Royal National Throat Nose and Ear Hospital
London
WC1X 8DA
United Kingdom
WC1X 8DA
United Kingdom
Sponsor information
Royal Free Hampstead NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Royal Free Hospital
Pond Street
London
NW3 2QG
England
United Kingdom
| Website | http://www.royalfree.org.uk/ |
|---|---|
"ROR" |
https://ror.org/04rtdp853 |
Funders
Funder type
Industry
Pentax UK Limited (UK) - funding analysis; analysis is being completed independantly by the Courtyard Group.
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 |
Editorial Notes
12/09/2016: No publications found, verifying study status with principal investigator.
