Randomised trial comparing the efficacy and costs of endoscopy with Helicobacter pylori testing versus non-invasive Helicobacter pylori testing alone in the management of dyspepsia
| ISRCTN | ISRCTN91662361 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91662361 |
| Secondary identifying numbers | HTA 94/41/17 |
- Submission date
- 25/04/2003
- Registration date
- 25/04/2003
- Last edited
- 27/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Kenneth McColl
Scientific
Scientific
University Dept of Medicine and Therapeutics
University of Glasgow
44 Church Street
Glasgow
G11 6NT
United Kingdom
| Phone | +44 (0)141 211 2513 |
|---|---|
| K.E.L.McColl@clinmed.gla.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Scientific title | |
| Study objectives | Dyspepsia is a common problem in the U.K. and accounts for 10% of GP attendance and 30% of hospital GI clinic referrals. Patients with persisting dyspepsia are investigated by upper GI endoscopy in order to diagnose the underlying cause and determine the most appropriate management. The demand for diagnostic endoscopy continues to increase and currently costs the NHS more than 100 million per year. The procedure also causes the patient significant discomfort and inconvenience. Studies in our own unit and other centres suggests that non-invasive Helicobacter pylori testing might replace endoscopy in determining the management of a substantial proportion of patients with simple dyspepsia. In order to asses this we propose a randomised controlled trial comparing endoscopy versus non-invasive H.pylori testing in patients with dyspepsia who are less than 55 years and have no sinister symptoms. The study will also allow identification of the patients who will benefit most from the non-endoscopic management. The ability to replace endoscopy by non-invasive test should result in major savings to the health budget and save the patient the discomfort of invasive procedure. It will also allow most dyspeptic patients to be managed definitively in primary care and without the need to attend hospital clinics or endoscopy units. |
| Ethics approval(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | Digestive system diseases: Peptic ulcer disease |
| Intervention | 1. Endoscopy 2. Non-invasive H. pylori testing |
| Intervention type | Other |
| Primary outcome measure | Glasgow dyspepsia severity score at one year. |
| Secondary outcome measures | Use of medical resources, patient oriented outcomes, and safety were also assessed. |
| Overall study start date | 01/08/1997 |
| Completion date | 31/08/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 708 |
| Key inclusion criteria | Patients with dyspepsia who are less than 55 years old with no sinister symptoms |
| Key exclusion criteria | Not provided at time of registration. |
| Date of first enrolment | 01/08/1997 |
| Date of final enrolment | 31/08/2001 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
University Dept of Medicine and Therapeutics
Glasgow
G11 6NT
United Kingdom
G11 6NT
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
| Phone | +44 (0)1132 545 843 |
|---|---|
| Sheila.Greener@doh.gsi.gov.uk | |
| Website | http://www.dh.gov.uk/en/index.htm |
"ROR" |
https://ror.org/03sbpja79 |
Funders
Funder type
Government
NIHR Health Technology Assessment Programme - HTA (UK)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 27/04/2002 | Yes | No |
