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 |
| Protocol serial number | N0084144516 |
| Sponsor | Department of Health |
| Funders | The North and South Bank Research and Development Consortium (UK), NHS R&D Support Funding |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| 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 sample size at registration | 200 |
| 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
- United Kingdom
- England
Study participating centre
GI Physiology Department
Hull
HU16 5JQ
United Kingdom
HU16 5JQ
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 |
