Double blind prospective randomised controlled trial of antibiotic prophylaxis for percutaneous endoscopic gastrostomy (PEG)
| ISRCTN | ISRCTN53943193 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53943193 |
| Secondary identifying numbers | N0557099429 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 08/07/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr BJM Jones
Scientific
Scientific
Department of Gastroenterology
Russells Hall Hospital
Dudley
DY1 2HQ
United Kingdom
| Phone | +44 01384 244074 |
|---|---|
| b.j.m.j@btinternet.com |
Study information
| Study design | Double blind prospective 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 | Does antibiotic prophylaxis reduce post PEG sepsis compared to placebo in a cohort of British district general hospital patients? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Injury, Occupational Diseases, Poisoning: Post percutaneous endoscopic gastrostomy sepsis |
| Intervention | 1. Antibiotic 2. Placebo |
| Intervention type | Other |
| Primary outcome measure | One week post procedure, sepsis present (graded) or sepsis free. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/08/2001 |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 200 |
| Key inclusion criteria | 200 patients referred for PEG insertion. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/08/2001 |
| Date of final enrolment | 31/12/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Gastroenterology
Dudley
DY1 2HQ
United Kingdom
DY1 2HQ
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
The Dudley Group of Hospitals NHS Trust (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 | 15/09/2005 | Yes | No |
