A prospective, pilot, randomised, controlled trial of continuous versus bolus feeding in gastrostomy fed patients
| ISRCTN | ISRCTN86016963 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86016963 |
| Protocol serial number | N0192147123 |
| Sponsor | Department of Health |
| Funders | Queen's Medical Centre University Hospital NHS Trust (UK), NHS R&D Support Funding |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 29/03/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- 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 T E Bowling
Scientific
Scientific
Consultant in Gastroenterology and Clinical Nutrition
Queens Medical Centre
University Hospital
Nottingham
NG7 2UH
United Kingdom
| Phone | +44 115 9249924 |
|---|---|
| tim.bowling@nuh.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | A prospective, pilot, randomised, controlled trial of continuous versus bolus feeding in gastrostomy fed patients |
| Study objectives | To establish in patients being fed by Percutaneous Endoscopic Gastrostomy (PEG) whether bolus fed patients have a lower incidence of feeding related complications than patients fed via continuous infusion and to determine patient preference between the two methods of feeding. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Gastrostomy |
| Intervention | Randomised Controlled Trial: 1: Continuous Feeding 2: Bolus Feeding |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
To examine the differences in enteral feeding complication in those patients who are fed via continuous infusion or via bolus feeding. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/09/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 60 |
| Key inclusion criteria | 60 patients being fed Percutaneous Endoscopic Gastrostomy (PEG). Patient and/or carer must, in the opinion of the researcher be able to comply with the protocol. Anticipated length of time on tube feeding greater than the study period: 10 weeks. Patient suitable for standard polymeric fibre feed: patients not taking diet orally. |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/04/2004 |
| Date of final enrolment | 30/09/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Consultant in Gastroenterology and Clinical Nutrition
Nottingham
NG7 2UH
United Kingdom
NG7 2UH
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
29/02/2016: No publications found, verifying study status with principal investigator.
29/03/2016: No publications found, verifying study status with principal investigator.
