Contact information
Type
Scientific
Primary contact
Dr T E Bowling
ORCID ID
Contact details
Consultant in Gastroenterology and Clinical Nutrition
Queens Medical Centre
University Hospital
Nottingham
NG7 2UH
United Kingdom
+44 115 9249924
tim.bowling@nuh.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0192147123
Study information
Scientific title
A prospective, pilot, randomised, controlled trial of continuous versus bolus feeding in gastrostomy fed patients
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Not Specified
Patient information sheet
Condition
Surgery: Gastrostomy
Intervention
Randomised Controlled Trial:
1: Continuous Feeding
2: Bolus Feeding
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
To examine the differences in enteral feeding complication in those patients who are fed via continuous infusion or via bolus feeding.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/04/2004
Overall trial end date
30/09/2005
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
60
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/04/2004
Recruitment end date
30/09/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Consultant in Gastroenterology and Clinical Nutrition
Nottingham
NG7 2UH
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Queen's Medical Centre University Hospital NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary