Helicobacter testing to rationalise use of endoscopy
| ISRCTN | ISRCTN31675962 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31675962 |
| Protocol serial number | PSI03-32 |
| Sponsor | Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK) |
| Funder | NHS Primary and Secondary Care Interface National Research and Development Programme (UK) |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 01/04/2009
- 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 Roger Jones
Scientific
Scientific
General Practice & Primary Care
Guys, Kings & St Thomas School of Medicine
5 Lambeth Walk
London
SE11 6SP
United Kingdom
| Phone | +44 (0)207 735 8881/2 |
|---|---|
| roger.jones@kcl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To determine whether the use of a Helicobacter pylori 'test and treat' strategy in general practice was associated with any improvement in clinical outcome or resource utilisation. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Peptic ulcer disease |
| Intervention | Randomised trial comparing a Helicobacter pylori test-and-treat strategy with referral to direct access endoscopy in the management of dyspepsia in general practice. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Helicobacter pylori |
| Primary outcome measure(s) |
1. Health care utilisation |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 01/09/1998 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 232 |
| Key inclusion criteria | A control group of practices in south east London pursuing 'usual' management of Helicobacter pylori, including endoscopy compared with a study group in which a near-patient test kit for Helicobacter pylori was provided for use on all patients under the age of 45 with persistent dyspepsia. |
| Key exclusion criteria | Does not meet with inclusion criteria |
| Date of first enrolment | 01/05/1995 |
| Date of final enrolment | 01/09/1998 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
General Practice & Primary Care
London
SE11 6SP
United Kingdom
SE11 6SP
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/1999 | Yes | No |
