A randomised controlled pilot study in the use of hyperbaric oxygen therapy versus metronidazole in chronic pouchitis
| ISRCTN | ISRCTN83399182 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83399182 |
| Secondary identifying numbers | N0084118523 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 28/07/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- 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 Gerald Laden
Scientific
Scientific
Hyperbaric Medicine Unit
BUPA, Hull & East Ridings
Hull
HU10 7AZ
United Kingdom
| gerardladen@aol.com |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | A randomised controlled pilot study in the use of hyperbaric oxygen therapy versus metronidazole in chronic pouchitis |
| Study objectives | To assess the benefits and effectiveness of hyperbaric oxygenation as a potential new treatment for chronic or refractory pouchitis. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Pouchitis |
| Intervention | Randomised controlled trial comparing: 1. Hyperbaric oxygen therapy 2. Metronizadole |
| Intervention type | Mixed |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 30/09/2002 |
| Completion date | 10/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Total number required: 30 |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 30/09/2002 |
| Date of final enrolment | 10/12/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Hyperbaric Medicine Unit
Hull
HU10 7AZ
United Kingdom
HU10 7AZ
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 North and South Bank Research and Development Consortium (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 |
Editorial Notes
28/07/2017: No publications found in PubMed, verifying study status with principal investigator.
