Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000456651
Ethics application status
Approved
Date submitted
13/09/2005
Date registered
21/09/2005
Date last updated
20/08/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Preoperative oral carbohydrate administration in patients undergoing elective major abdominal surgery: a randomised controlled trial.
Scientific title
A double-blind, randomised, placebo-controlled trial to investigate effects of preoperative oral carbohydrate on postoperative fatigue in patients undergoing elective major abdominal surgery.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients requiring major lower GI surgery or liver resection 571 0
Condition category
Condition code
Surgery 647 647 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single-centre, randomised, double-blind study comparing oral carbohydrate drink (PreOp, Nutricia) provided preoperatively up to 2 hours prior to major abdominal surgery.
Intervention code [1] 597 0
None
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 763 0
Fatigue score
Timepoint [1] 763 0
Measured on postoperative day 4
Secondary outcome [1] 1552 0
Insulin resistance
Timepoint [1] 1552 0
On postoperative days 1 and 3.
Secondary outcome [2] 1553 0
Length of hospital stay
Timepoint [2] 1553 0
Hospital discharge
Secondary outcome [3] 1554 0
Postoperative infectious complications
Timepoint [3] 1554 0
First 30 postoperative days
Secondary outcome [4] 1555 0
Grip strength
Timepoint [4] 1555 0
On postoperative days 3 and 5.

Eligibility
Key inclusion criteria
Elective major abdominal surgery (lower GI surgery and liver resection); age 18-80; ASA I-III; eligible for preoperative intake of clear fluids; written informed consent.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diabetes type 1 or 2; emergency surgery; GI obstruction; pregnancy; on steroids (prednisone>5 mg/d).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated stratified blocks
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 224 0
New Zealand
State/province [1] 224 0

Funding & Sponsors
Funding source category [1] 707 0
Commercial sector/Industry
Name [1] 707 0
Nutricia NZ
Country [1] 707 0
New Zealand
Primary sponsor type
Individual
Name
Dr Lindsay Plank
Address
Department of Surgery, University of Auckland, P.B. 92019, Auckland
Country
New Zealand
Secondary sponsor category [1] 592 0
None
Name [1] 592 0
Nil
Address [1] 592 0
Country [1] 592 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35119 0
Address 35119 0
Country 35119 0
Phone 35119 0
Fax 35119 0
Email 35119 0
Contact person for public queries
Name 9786 0
Dr Lindsay Plank
Address 9786 0
Department of Surgery
University of Auckland
Private Bag 92019
Auckland
Country 9786 0
New Zealand
Phone 9786 0
+64 9 3074935
Fax 9786 0
+64 9 3779656
Email 9786 0
l.plank@auckland.ac.nz
Contact person for scientific queries
Name 714 0
Dr Lindsay Plank
Address 714 0
Department of Surgery
University of Auckland
Private Bag 92019
Auckland
Country 714 0
New Zealand
Phone 714 0
+64 9 3074935
Fax 714 0
+64 9 3779656
Email 714 0
l.plank@auckland.ac.nz

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.