A comparison of endoscopic and radiological methods of placement of large bore gastrostomy tubes
| ISRCTN | ISRCTN44313851 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44313851 |
| Protocol serial number | N0226118476 |
| Sponsor | Department of Health (UK) |
| Funder | South Manchester University Hospitals NHS Trust (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 11/02/2010
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Surgery
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
Dr Derrick F Martin
Scientific
Scientific
Main X Ray Area A
South Manchester University Hospitals NHS Trust
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
| Phone | +44 (0)161 291 6237 |
|---|---|
| derrick.martin@smuht.nwest.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To compare the success and complication rates of the modified and the endoscopic method in a prospective randomised study. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Gastrostomy tube insertion |
| Intervention | To compare the success and complication rates of the modified and the endoscopic method. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Successful insertion of gastrostomy tube at the first attempt. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/12/2004 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 200 |
| Key inclusion criteria | 200 Consecutive patients undergoing percutaneous gastrostomy (100 each arm). |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/12/2002 |
| Date of final enrolment | 01/12/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Main X Ray Area A
Manchester
M23 9LT
United Kingdom
M23 9LT
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 |
