Condition category
Digestive System
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
28/04/2015
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

Prof Graham Smith

ORCID ID

Contact details

University of Leicester
Leicester Royal Infirmary
Infirmary Square
Leicester
LE1 5WW
United Kingdom
+44 (0)116 258 5291
gs30@le.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RBF 99X22

Study information

Scientific title

The effect of early oral nutrition and mobilisation on post-operative recovery after major bowel surgery

Acronym

Study hypothesis

A patient's recovery after bowel surgery is inhibited by many factors but a common one is post-operative ileus which persists for 3 - 7 days after operation. Typically therefore patients are not fed but are treated with a naso-gastric tube and free drainage with intravenous fluids for 3 - 5 days post-operatively.

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

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Bowel surgery

Intervention

Early oral nutrition and mobilisation on post-operative recovery versus treatment as usual.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Time to passage of first flatus and time to first bowel sounds
2. Visual analogue pain scores will be obtained at rest and during a standard movement at 12-hourly intervals
3. Volume of fluid and/or food taken orally and IV over the duration of the study
4. Fatigue scores will be collected at 12 hourly intervals after operation
5. The time at which patients walk unaided to the bathroom will also be noted

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/08/2000

Overall trial end date

31/07/2002

Reason abandoned

Eligibility

Participant inclusion criteria

Propose to study 50 patients per group.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

100

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/08/2000

Recruitment end date

31/07/2002

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Leicester
Leicester
LE1 5WW
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
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.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive Trent (UK)

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