Condition category
Surgery
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
29/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes

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