NATO Study
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Principal Investigator
Dr Lachlan Miles
Project Details
NATO: Non Anaemic Iron Deficiency and Treatment Outcomes after Colorectal Cancer Surgery
Aim: This study will aim to assess if non-anaemic iron deficiency (NAID) influences outcome relative to a non-anaemic iron replete (NAIR) cohort after surgery for colorectal cancer.
Background: Based on data published in 2005, the majority of patients with colorectal cancer present with iron deficiency. In right-sided lesions, the incidence of NAID is 11%, and in left sided lesions, the incidence is 27%. Evidence in the literature from other populations suggests that NAID is important, modifiable risk factors to improve outcome. Patients with heart failure have a lower incidence of hospital admission and all cause mortality when NAID is corrected. Patients with COPD have an improved response to exercise training when NAID is corrected. Otherwise well women and endurance athletes experience improvements in in exercise capacity, fatigue and mental acuity when NAID is corrected.
At the same time, it is recognised that intraoperative and postoperative transfusion has an important impact on short- and long-term outcome after colorectal cancer surgery. Allogeneic blood transfusion is linked to a higher incidence of cancer recurrence, wound infection and respiratory complications. It is biologically plausible that those patients without an adequate store of iron (absolute iron deficiency), or a store of iron that they cannot effectively access (functional iron deficiency) will have deficient eryththropoesis after a surgical insult, and hence a higher incidence of transfusion. However, this hypothesis is yet to be investigated or even tested in the literature. Given the evidence in other populations, it is also possible that correction of NAID will lead to improvements in fatigue and performance status, leading to a shorter hospital stay, improvement in functional status, and earlier return to intended oncological therapy.
Primary Outcome Measure:
- Allogeneic blood transfusion during inpatient stay for major colorectal cancer surgery.
Secondary Outcome Measures:
- Duration of inpatient stay;
- Days alive and out of hospital at day 90;
- Pre-operative functional status as measured by SF-12;
- Post-operative functional status at day 30 as measured by SF-12;
- Baseline haemoglobin;
- Haemoglobin at day 3 post-operatively.
Study Design: This will be a prospective, observational study of patients undergoing colorectal cancer surgery at University of Melbourne hospitals and Geelong Hospital. Ideally, all patients at these centres will have iron studies taken as part of routine pre-operative workup, allowing identification and 1:1 recruitment prior to enrolment into the trial.
Patients will undergo SF-12 testing prior to surgery, as well as a 6MWT. They will have post-operative data collected, and will be contacted at 30 and 90 days post-operatively to retake SF-12 and assess DAoH-90.
Researchers
Dr Lachlan Miles
Prof David Story
Professor Bernhard Riedel
Dr Kate Burbury
Ms Adele Burgess
Ms Sabine Braat
Dr Hilmy Ismail
Dr Andrew Marriot
Dr Hugh Taylor
Dr Nicole Tan
Collaborators
Albury Wodonga Health
Austin Health
Alfred Health
Ballarat Base Hospital
Barwon Health
Bendigo Health
Epworth HealthCare
Flinders Medical Centre
Goulburn Valley Health
John Hunter Hospital
Middlemore Hospital, New Zealand
North Shore Hospital, New Zealand
Peter MacCallum Cancer Centre
Prince of Wales Hospital
Princess Alaexandra Hospital
St Vincent's Hospital, Melbourne
Western Health
Vifor Pharma
Funding
Vifor Pharma
Department of Health and Human Services