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 |
| Protocol serial number | N0084118523 |
| Sponsor | Department of Health (UK) |
| Funder | The North and South Bank Research and Development Consortium (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 10/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Hyperbaric Medicine Unit
Hull
HU10 7AZ
United Kingdom
HU10 7AZ
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 |
Editorial Notes
28/07/2017: No publications found in PubMed, verifying study status with principal investigator.
