A prospective, pilot, randomised, controlled trial of continuous versus bolus feeding in gastrostomy fed patients

ISRCTN	ISRCTN86016963
DOI	https://doi.org/10.1186/ISRCTN86016963
Secondary identifying numbers	N0192147123

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

Consultant in Gastroenterology and Clinical Nutrition
Queens Medical Centre
University Hospital
Nottingham
NG7 2UH
United Kingdom

Phone	+44 115 9249924
Email	tim.bowling@nuh.nhs.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Not Specified
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	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 study start date	01/04/2004
Completion date	30/09/2005

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	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

England
United Kingdom

Study participating centre

Consultant in Gastroenterology and Clinical Nutrition

Nottingham
NG7 2UH
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Queen's Medical Centre University Hospital NHS Trust (UK)

No information available

NHS R&D Support Funding

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

29/02/2016: No publications found, verifying study status with principal investigator.
29/03/2016: No publications found, verifying study status with principal investigator.