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The effect of pre-operative oral immunonutrition therapy on postoperative outcomes in gastrointestinal surgery patients.

Does Impact Advanced Recovery given pre-operatively to elective upper and lower gastrointestinal surgical patients reduce length of stay?

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12608000035325
Enrollment
150
Registered
2008-01-22
Start date
2008-01-14
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Sponsors

Lisa Barker
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

Elective upper or lower gastrointestinal surgery

Exclusion criteria

Chronic respiratory or cardiac dysfunction, Hepatic dysfunction, Chronic infection or immunosupression, Renal failure

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026