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NATO – Non Anaemic Iron Deficiency and Treatment Outcomes after Colorectal Cancer Surgery

A prospective observational study to determine if non-anaemic iron deficiency increases the risk of poor post-operative outcome relative to an iron replete control in patients undergoing surgery for colorectal malignancy.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12618001997246
Acronym
NATO
Enrollment
422
Registered
2018-12-12
Start date
2019-05-07
Completion date
2023-04-17
Last updated
2023-05-01

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

Conditions

None listed

Brief summary

The purpose of this study is to assess whether there is a role of non-anaemic iron deficiency in colorectal cancer. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with colorectal cancer, and are also scheduled to undergo surgery for colorectal cancer. Study details Participants will continue with their current cancer treatment plan, and answer questionnaires in regards to their health over a 3-month period following their surgery. The results of certain blood tests will also be used. These blood tests are taken as part of routine care. You will not be required to have additional blood tests if you are participating in this study. The results of participants with iron deficiency prior to their surgery will be compared to those without iron deficiency. We hope that this study will show that iron replete patients have improved recovery after surgery for colorectal cancer, and enable more widespread research into the role of iron treatments prior to this sort of surgery.

Interventions

This is a non-interventional study. Patients will not receive any treatment additional to current standard of care. The "intervention" group will be patients undergoing surgery for colorectal cancer who are non-anaemic and iron deficient. They will be followed from the time of surgery until 90 days after the primary surgical procedure.

Sponsors

Department of Critical Care, University of Melbourne
Lead SponsorUniversity

Eligibility

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

Inclusion criteria

Patient scheduled to undergo major elective surgery for colorectal cancer (laparoscopic or open colectomy, anterior resection or abdominoperineal resection).

Exclusion criteria

Pregnancy Age < 18 years Iron supplementation (oral or parenteral) or EPO therapy received or planned between baseline preoperative blood tests and operation Haemoglobinopathy (thalassaemia or sickle cell) Bone marrow disease or haemochromatosis End-stage renal failure requiring dialysis Pre-operative anaemia (female: Hb < 120g/L, male: Hb < 130 g/L) Pelvic exenteration or secondary surgical procedure (i.e. bowel resection AND liver resection during the same surgical procedure)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 19, 2026