Consultants and Physiology technicians: A comparative analysis of treatment pathways for patients with gastro oesophageal reflux disease and dysphagia.
| ISRCTN | ISRCTN85216012 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85216012 |
| Secondary identifying numbers | N0084144516 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 21/04/2011
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Digestive System
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
Mr Warren Jackson
Scientific
Scientific
GI Physiology Department
Castle Hill Hospital
Castle Road
Hull
HU16 5JQ
United Kingdom
| Phone | +44 Ext 2155 |
|---|---|
| warrenjackson72@hotmail.com |
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 |
| Scientific title | |
| Study objectives | Proposing an alternative fast track route of treatment. Patients suspected of having an oesophageal disorder and/or GORD would be referred via the consultant surgeon/physician/upper GI nurse practitioner or GP. Patients would initially undergo an endoscopy. After an endoscopy has excluded any serious and significant pathology, the technician would carry out oesophageal manometry and 24 hour pH studies. After performing the studies the technician will then make a diagnosis, based upon the results. Upon an abnormal diagnosis, of oesophagical function or GORD made, patients will then be asked to take part in the proposed study and will be randomised to either consultant or technician mediated treatment. Resources: investigator's time. Per patient: one hour of investigator's time. Pharmacy department will issue medication. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Digestive System: Gastro-oesophageal reflux disease (GORD) |
| Intervention | Randomisation to either consultant or technician mediated treatment. Added July 2008: the trial was stopped due to lack of funding. |
| 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 | 01/06/2002 |
| Completion date | 01/10/2004 |
| Reason abandoned (if study stopped) | Lack of funding |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Approximately 200 patients |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/06/2002 |
| Date of final enrolment | 01/10/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
GI Physiology Department
Hull
HU16 5JQ
United Kingdom
HU16 5JQ
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
The North and South Bank Research and Development Consortium (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 |
