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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm | Active Comparator | intravenous iron isomaltose 3-10 weeks before operation date. The dose will be determined by the patient's body weight: > 50kg: 1000mg; <50kg: 20mg/kg body weight, to be infused over 30 minutes. 2 weeks after intravenous iron isomaltoside administration, blood test for hemoglobin level and iron profile would be repeated. Subjects with hemoglobin level less than 10g/dL will receive a second dose of intravenous iron isomaltoside. The second dose would be identical to the first dose |
|
| Control arm | No Intervention | Patient randomized to the control arm will follow the standard perioperative care and the perioperative management they received will be identical to the treatment arm except no intravenous iron isomaltoside will be given. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iron isomaltoside(Monofer®) | Drug | intravenous iron isomaltoside |
|
| Measure | Description | Time Frame |
|---|---|---|
| Preoperative change in hemoglobin concentration (g/dL) | the difference between the value at diagnosis(baseline) and preoperative day (3-10weeks after diagnosis). | 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). | 3 weeks to 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Units of red blood cells transfused in perioperative period | Units of red blood cells transfused from diagnosis to discharge | 3 weeks to 12 weeks |
| Duration of hospital stay (days) | 1 days up to 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Patient recruitment rate(%) | number of recruited patients divided by number of eligible patients x 100% | through study completion, an average of 1 year |
| Number of patients recruited per month | through study completion, an average of 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince of Wales Hospital | Shatin | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35771891 | Derived | Fung PLP, Lau VNM, Ng FF, Leung WW, Mak TWC, Lee A. Perioperative changes in haemoglobin and ferritin concentrations from preoperative intravenous iron isomaltoside for iron deficiency anaemia in patients with colorectal cancer: A pilot randomised controlled trial. PLoS One. 2022 Jun 30;17(6):e0270640. doi: 10.1371/journal.pone.0270640. eCollection 2022. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 3, 2018 | May 28, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Quality of recovery as measured by questionnaire (QoR-15(Chinese)) | post op day 3 |
| Incidence of adverse reactions/serious adverse events to intravenous iron administration and adverse reaction to blood transfusions | up to post op day 30 |
| Rate of surgical complications | recorded and graded according to Clavien Classification of Surgical Complications | up to post op day 30 |
| Days (alive and) at home within 30 days of surgery (DAH30) | up to post op day 30 |
| Median waiting time to surgery (days) | through study completion, an average of 1 year |
| D000090463 |
| Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |