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
Protocol serial number	RBF 99X22
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive Trent (UK)

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

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	The effect of early oral nutrition and mobilisation on post-operative recovery after major bowel surgery
Study objectives	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
Health condition(s) or problem(s) studied	Bowel surgery
Intervention	Early oral nutrition and mobilisation on post-operative recovery versus treatment as usual.
Intervention type	Other
Primary outcome measure(s)	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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/07/2002

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	100
Key inclusion criteria	Propose to study 50 patients per group.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/08/2000
Date of final enrolment	31/07/2002

University of Leicester

Leicester
LE1 5WW
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

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