Reduction of surgical stress by prevention of perioperative starvation

ISRCTN	ISRCTN89225485
DOI	https://doi.org/10.1186/ISRCTN89225485
Secondary identifying numbers	N0185146353

Submission date: 30/09/2005
Registration date: 30/09/2005
Last edited: 28/03/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr S Lewis
Scientific

level 09
Derriford Hospital
Plymouth
PL6 8DH
United Kingdom

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectives	Does feeding surgical patients improve intestinal permeability and insulin resistance? The purpose of this study is to examine the effect of maintaining patients nutritional intake in the pre and postoperative period on insulin resistance, nitrogen turnover and intestinal permeability.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Surgery
Intervention	The day before the operation study patients will be encouraged to take clear liquid dietary supplements during the day before their operation and on the day of their operation. Patients in group A will receive a placebo supplement of flavoured water. Patients in groups B and C will receive Fortisip. The amount of supplements will be measured to meet the patients calculated daily energy requirement. On the operative day patients will take 200ml of supplement drink at 8am then another 200ml 4 hours before their operations. In the postoperative period patient will be encouraged to take the liquid supplements as tolerated from the period immediately after their operation until normal diet is resumed. Patients in groups A and B will receive placebo supplement drinks whilst those in group C will receive Fortijuice. Insulin resistance will be measured using the HOMA method and by using a short insulin tolerance test. Intestinal permeability will be measured using a duel sugar test.
Intervention type	Procedure/Surgery
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	12/09/2002
Completion date	09/02/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target number of participants	60
Key inclusion criteria	60 participants in total - 40 experimental group, 20 control.
Key exclusion criteria	<18 years, diabetic, pregnant or lactating, receiving tube delivered nutrition, participating in another study.
Date of first enrolment	12/09/2002
Date of final enrolment	09/02/2008

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

level 09

Plymouth
PL6 8DH
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

Plymouth Hospitals NHS Trust

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2010		Yes	No