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Trial registered on ANZCTR


Registration number
ACTRN12618001997246
Ethics application status
Approved
Date submitted
7/12/2018
Date registered
12/12/2018
Date last updated
12/12/2018
Date data sharing statement initially provided
12/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
NATO – Non Anaemic Iron Deficiency and Treatment Outcomes after Colorectal Cancer Surgery
Scientific title
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.
Secondary ID [1] 296814 0
Nil
Universal Trial Number (UTN)
U1111-1225-1465
Trial acronym
NATO
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
Iron deficiency 310699 0
Colorectal cancer 310702 0
Condition category
Condition code
Cancer 309401 309401 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Surgery 309402 309402 0 0
Other surgery
Blood 309403 309403 0 0
Other blood disorders
Metabolic and Endocrine 309434 309434 0 0
Other metabolic disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Intervention code [1] 313101 0
Not applicable
Comparator / control treatment
This is a non-interventional study. Patients will not receive any treatment additional to current standard of care. The "control" group will be patients undergoing surgery for colorectal cancer who are non-anaemic and iron replete. They will be followed from the time of surgery until 90 days after the primary surgical procedure.
Control group
Active

Outcomes
Primary outcome [1] 308367 0
Days alive and out of hospital (DAOH-90). The outcome will be assessed using patient interview and the medical record.
Timepoint [1] 308367 0
Measured on day 90 after the primary operation.
Secondary outcome [1] 354760 0
Duration of hospital stay. The outcome will be assessed using patient interview and the medical record.
Timepoint [1] 354760 0
Measured at the end of acute health care admission for the primary surgical procedure.
Secondary outcome [2] 354761 0
Days alive and out of hospital (DAOH-30). The outcome will be assessed using patient interview and the medical record.
Timepoint [2] 354761 0
Measured on day 30 after the primary operation.
Secondary outcome [3] 354762 0
WHODAS-2.0 The outcome will be assessed using patient interview.
Timepoint [3] 354762 0
Measured at baseline and on day 90 after the primary operation.
Secondary outcome [4] 354763 0
EQ-5D-5L. The outcome will be assessed using patient interview.
Timepoint [4] 354763 0
Measured at baseline and on day 30 after the primary operation.
Secondary outcome [5] 354764 0
Quality of recovery score (QoR-15). The outcome will be assessed using patient interview.
Timepoint [5] 354764 0
Measured on day 3 after the primary operation.
Secondary outcome [6] 354765 0
Haemoglobin concentration (g/L). The outcome will be assessed using the medical record.
Timepoint [6] 354765 0
Measured at baseline, and on day 3 and day of discharge from acute care after the primary operation.
Secondary outcome [7] 354766 0
Requirement for allogeneic blood transfusion. The outcome will be assessed using the medical record.
Timepoint [7] 354766 0
Measured on day 30 after the primary operation.
Secondary outcome [8] 354767 0
All cause infection. The outcome will be assessed using the medical record.
Timepoint [8] 354767 0
Measured up to day 90 after the primary operation.

Eligibility
Key inclusion criteria
Patient scheduled to undergo major elective surgery for colorectal cancer (laparoscopic or open colectomy, anterior resection or abdominoperineal resection).
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy
Age < 18 years
Iron supplementation (oral or parenteral) or EPO therapy in the preceding 4 weeks prior to surgery
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)

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Student’s t-test or Wilcoxon test
Chi-squared test or Fisher's exact test
Cox proportional hazards model
Quantile regression analysis

Recruitment
Recruitment status
Not yet recruiting
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)
VIC
Recruitment hospital [1] 12674 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 12675 0
Western Hospital - Footscray - Footscray
Recruitment hospital [3] 12676 0
Sunshine Hospital - St Albans
Recruitment hospital [4] 12677 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [5] 12678 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [6] 12679 0
Epworth Eastern Hospital - Box Hill
Recruitment hospital [7] 12680 0
Epworth Richmond - Richmond
Recruitment hospital [8] 12681 0
Epworth Hospital Geelong - Waurn Ponds
Recruitment hospital [9] 12682 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment hospital [10] 12683 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Recruitment postcode(s) [1] 25096 0
3084 - Heidelberg
Recruitment postcode(s) [2] 25097 0
3011 - Footscray
Recruitment postcode(s) [3] 25098 0
3021 - St Albans
Recruitment postcode(s) [4] 25099 0
3065 - Fitzroy
Recruitment postcode(s) [5] 25100 0
3000 - Melbourne
Recruitment postcode(s) [6] 25101 0
3128 - Box Hill
Recruitment postcode(s) [7] 25102 0
3121 - Richmond
Recruitment postcode(s) [8] 25103 0
3216 - Waurn Ponds
Recruitment postcode(s) [9] 25104 0
3220 - Geelong
Recruitment postcode(s) [10] 25105 0
3081 - Heidelberg West

Funding & Sponsors
Funding source category [1] 301387 0
Hospital
Name [1] 301387 0
Austin Hospital Colorectal Surgery Research SPF
Address [1] 301387 0
Austin Health
145 Studley Road
HEIDELBERG VIC 3084
Country [1] 301387 0
Australia
Funding source category [2] 301399 0
Other
Name [2] 301399 0
Epworth Research Institute
Address [2] 301399 0
89 Bridge Road
RICHMOND VIC 3121
Country [2] 301399 0
Australia
Funding source category [3] 301400 0
Commercial sector/Industry
Name [3] 301400 0
Vifor Pharma Pty Ltd
Address [3] 301400 0
Level 8, 80 Dorcas Street
SOUTHBANK VIC 3006
Country [3] 301400 0
Australia
Primary sponsor type
University
Name
Centre for Integrated Critical Care, University of Melbourne
Address
Department of Medicine & Radiology
Melbourne Medical School
Faculty of Medicine, Dentistry & Health Sciences
The University of Melbourne
PARKVILLE VIC 3010
Country
Australia
Secondary sponsor category [1] 301075 0
None
Name [1] 301075 0
Address [1] 301075 0
Country [1] 301075 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302125 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 302125 0
Level 8, Lance Townsend Building
Austin Health
145 Studley Road
HEIDELBERG VIC 3084
Ethics committee country [1] 302125 0
Australia
Date submitted for ethics approval [1] 302125 0
09/03/2018
Approval date [1] 302125 0
21/06/2018
Ethics approval number [1] 302125 0
HREC/17/Austin/350

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89202 0
Dr Lachlan Miles
Address 89202 0
Department of Anaesthesia
Austin Health
145 Studley Road
HEIDELBERG VIC 3084
Country 89202 0
Australia
Phone 89202 0
+61 394965704
Fax 89202 0
Email 89202 0
lachlan.miles@austin.org.au
Contact person for public queries
Name 89203 0
Ms Anna Parker
Address 89203 0
Centre for Integrated Critical Care
Department of Medicine & Radiology
Melbourne Medical School
Level 1, Room 104, 202 Berkeley St
The University of Melbourne, VIC 3010
Country 89203 0
Australia
Phone 89203 0
+61 390359662
Fax 89203 0
Email 89203 0
anna.parker@unimelb.edu.au
Contact person for scientific queries
Name 89204 0
Dr Lachlan Miles
Address 89204 0
Department of Anaesthesia
Austin Health
145 Studley Road
HEIDELBERG VIC 3084
Country 89204 0
Australia
Phone 89204 0
+61 394965704
Fax 89204 0
Email 89204 0
lachlan.miles@austin.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data relating to participant demographics and outcomes. No data that may be used to re-identify participants will be shared.
When will data be available (start and end dates)?
Data will be available after the publication of the primary manuscript resulting from the study (anticipated Dec. 2021). Data will be available until 7 years after study conclusion.
Available to whom?
Academic authors. Requests from industry unaffiliated with an academic body such as a University will not be considered.
Available for what types of analyses?
Meta-analysis and systematic review.
How or where can data be obtained?
Electronic transfer.
What supporting documents are/will be available?
No other documents available
Summary results
No Results