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

ISRCTN	ISRCTN15405004
DOI	https://doi.org/10.1186/ISRCTN15405004
Secondary identifying numbers	RBF 99X22

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Not provided at time of registration

Prof Graham Smith
Scientific

University of Leicester
Leicester Royal Infirmary
Infirmary Square
Leicester
LE1 5WW
United Kingdom

Phone	+44 (0)116 258 5291
Email	gs30@le.ac.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	The effect of early oral nutrition and mobilisation on post-operative recovery after major bowel surgery
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(s)	Not provided at time of registration
Condition	Bowel surgery
Intervention	Early oral nutrition and mobilisation on post-operative recovery versus treatment as usual.
Intervention type	Other
Primary outcome measure	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 study start date	01/08/2000
Overall study end date	31/07/2002

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	100
Participant inclusion criteria	Propose to study 50 patients per group.
Participant exclusion criteria	Not provided at time of registration
Recruitment start date	01/08/2000
Recruitment end date	31/07/2002

University of Leicester

Leicester
LE1 5WW
United Kingdom

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

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Government

NHS Executive Trent (UK)

No information available

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

19/07/2017: No publications found in PubMed, verifying study status with principal investigator.