Iron deficiency anaemia is a common condition among colorectal surgical patient. Untreated anaemia would lead to increase in blood transfusion, surgical complications and mortality. Treatment with oral iron sulphate is poorly tolerated due to side effects. Intravenous iron supplement provides an alternative way to rapidly replace iron deficit during the preoperative period among surgical patients. Evidence is growing for its effect in rising hemoglobin level and reducing blood transfusion, at the same time supporting its safety profile. The investigators plan for a single-centered, randomized controlled trial to examine the effect of intravenous iron compared to standard care in terms of hemoglobin level/serum ferritin increment, need for blood transfusion, duration of hospital stay, quality of recovery and surgical complication rate, as well as safety profile among colorectal cancer surgical patients in Hong Kong. The investigator propose the following pilot RCT for exploring the effect size and study process in conducting the above-mentioned large-scale RCT.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
intravenous iron isomaltoside
Prince of Wales Hospital
Shatin, Hong Kong
Preoperative change in hemoglobin concentration (g/dL)
the difference between the value at diagnosis(baseline) and preoperative day (3-10weeks after diagnosis).
Time frame: 3 weeks to 10 weeks
Preoperative change in serum ferritin (mcg/L)
the difference between the value at diagnosis(baseline) and preoperative day (3-10weeks after diagnosis).
Time frame: 3 weeks to 10 weeks
Units of red blood cells transfused in perioperative period
Units of red blood cells transfused from diagnosis to discharge
Time frame: 3 weeks to 12 weeks
Duration of hospital stay (days)
Time frame: 1 days up to 1 month
Quality of recovery as measured by questionnaire (QoR-15(Chinese))
Time frame: post op day 3
Incidence of adverse reactions/serious adverse events to intravenous iron administration and adverse reaction to blood transfusions
Time frame: up to post op day 30
Rate of surgical complications
recorded and graded according to Clavien Classification of Surgical Complications
Time frame: up to post op day 30
Days (alive and) at home within 30 days of surgery (DAH30)
Time frame: up to post op day 30
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