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Trial registered on ANZCTR


Registration number
ACTRN12608000035325
Ethics application status
Approved
Date submitted
9/01/2008
Date registered
22/01/2008
Date last updated
7/10/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of pre-operative oral immunonutrition therapy on postoperative outcomes in gastrointestinal surgery patients.
Scientific title
Does Impact Advanced Recovery given pre-operatively to elective upper and lower gastrointestinal surgical patients reduce length of stay?
Secondary ID [1] 273178 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cancer 2683 0
Inflammatory Bowel Disease (IBD) 2684 0
Diverticular Disease 2685 0
obstruction / stricture 2686 0
Pancreatitis 2687 0
Condition category
Condition code
Diet and Nutrition 2805 2805 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment group patients given Impact Advanced Recovery (Novartis Medical Nutrition) 237ml tetra pack 3 times per day for 5 days prior to surgery. Impact is a specialised nutrition supplement drink, each pack containing (as major ingredints)340 Calories, 18.1g Protein, 4.2g Arganide and 1.1g Omega-3 Fatty Acids.
Intervention code [1] 2425 0
Treatment: Other
Comparator / control treatment
Control group - no intervention (no placebo)
Control group
Active

Outcomes
Primary outcome [1] 3693 0
Length of hospital stay
Timepoint [1] 3693 0
Measured from day of admission to day of discharge either home or to rehabilitation facility
Secondary outcome [1] 6232 0
Non-infectious complications
Timepoint [1] 6232 0
Measured daily over duration of hospital admission
Secondary outcome [2] 6233 0
Infectious complications
Timepoint [2] 6233 0
Measured daily over duration of hospital admission
Secondary outcome [3] 6234 0
Mortalily
Timepoint [3] 6234 0
Measured daily over duration of hospital admission

Eligibility
Key inclusion criteria
Elective upper or lower gastrointestinal surgery
Minimum age
18 Years
Maximum age
90 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Chronic respiratory or cardiac dysfunction, Hepatic dysfunction, Chronic infection or immunosupression, Renal failure

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)
Patients will be randomly allocated to a treatment group by a blind draw from an envelope of a numbered square of paper. The number of the square will represent the two groups, 1 or 2. This will be done by the researcher who is responsible for consenting the patient, so the appropriate ‘pack’ can be given out. Each pack will have written instructions for the participants to follow depending on their allocated treatment group. The allocated treatment group will be recorded on the initial data sheet only, and the researcher collecting data post-operatively will be blinded to the group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Treatment allocation (to either treatment group or control group) will be written on a peice of paper and placed into individual sealed envelope, which will then be randomley selected by the pre-admission nurse during recruitment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2941 0
Self funded/Unfunded
Name [1] 2941 0
Lisa Barker
Address [1] 2941 0
Dietitian
The Royal Melbourne Hosptial
Grattan Street
Parkville 3050
Country [1] 2941 0
Australia
Primary sponsor type
Individual
Name
Lisa Barker
Address
Dietitian
The Royal Melbourne Hosptial
Grattan Street
Parkville 3050
Country
Australia
Secondary sponsor category [1] 2655 0
None
Name [1] 2655 0
Address [1] 2655 0
Country [1] 2655 0
Other collaborator category [1] 126 0
Individual
Name [1] 126 0
Mr Ben Thomson
Address [1] 126 0
Surgeon
The Royal Melbourne Hosptial
Grattan Street
Parkville 3050
Country [1] 126 0
Australia
Other collaborator category [2] 127 0
Individual
Name [2] 127 0
Ms Lisa Wilson
Address [2] 127 0
Nurse
The Royal Melbourne Hosptial
Grattan Street
Parkville 3050
Country [2] 127 0
Australia
Other collaborator category [3] 128 0
Individual
Name [3] 128 0
Professor Ian Jones
Address [3] 128 0
Surgeon
The Royal Melbourne Hosptial
Grattan Street
Parkville 3050
Country [3] 128 0
Australia
Other collaborator category [4] 129 0
Individual
Name [4] 129 0
Dr Tim Crowe
Address [4] 129 0
Senior Lecturer Nutrition
Deakin University
221 Burwood Hwy
Burwood 3125
Country [4] 129 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4885 0
Melbourne Health
Ethics committee address [1] 4885 0
The Royal Melbourne Hosptial
Grattan Street
Parkville 3050
Ethics committee country [1] 4885 0
Australia
Date submitted for ethics approval [1] 4885 0
Approval date [1] 4885 0
27/11/2007
Ethics approval number [1] 4885 0
2007.182

Summary
Brief summary
It is well known that major surgery causes a decrease in immune function, which in turn can lead to an increased rate of post operative inflammation and infection. Recently, research has been focused on the role of pre-operative oral immune enhancing nutrition and its positive influences on inflammation, metabolism and immune responses after surgery. The positive effects shown in recent studies have also been linked to a decreased in length of hospital stay and substantially reduced treatment costs. Given the strong support in medical literature, the Departments of Surgery and Clinical Nutrition wish to examine the effect of Impact Advanced Recovery (Novartis Nutrition Corporation, United States of America) on major upper and lower bowel surgery patients. Eligible patients (all patients undergoing upper and lower bowel surgery at The Royal Melbourne Hospital - excluding patients who are inmmunosupressed, have chronic infections, hepatic disease or renal failure), will be randomized into one of two groups, treatment or control. The treatment group will receive Impact Advanced Recovery (237ml packs) three times a day for the five days leading up to surgery. The control group will receive no nutritional supplements, which is in line with current treatment. After their operation, patients will receive normal clinical care as per their managing surgical team. Outcome measures such as length of hospital stay, infection rate, non-infective complications, unexpected ICU admission and death will be measured by means of direct data collection from medical charts during the patients admission. A statistical analysis using an unpaired t-test and Fisher's exact test will be performed on the data. We hope this trial will support the need for The Royal Melbourne Hospital to provide immune enhancing nutritional supplements to patients prior to major upper and lower bowel surgery patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28281 0
Address 28281 0
Country 28281 0
Phone 28281 0
Fax 28281 0
Email 28281 0
Contact person for public queries
Name 11438 0
Lisa Barker
Address 11438 0
Dietitian
The Royal Melbourne Hosptial
Grattan St
Parkville 3050
Country 11438 0
Australia
Phone 11438 0
03 9342 7440
Fax 11438 0
Email 11438 0
Lisa.Barker@mh.org.au
Contact person for scientific queries
Name 2366 0
Lisa Barker
Address 2366 0
Dietitian
The Royal Melbourne Hosptial
Grattan St
Parkville 3050
Country 2366 0
Australia
Phone 2366 0
03 9342 7440
Fax 2366 0
Email 2366 0
Lisa.Barker@mh.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary