Cancer Colon
Conditions
Brief summary
The PICoC study aims to investigate whether oral ferric maltol given postoperatively offers an improvement in patient and clinician reported outcomes compared to standard care.
Detailed description
Colorectal cancer is associated with iron deficiency anaemia in 40-60% of cases. This anaemia can lead to poorer post-operative outcomes such as higher complication rates, increased length of stay and reduced survival. There has been a recent shift towards the correction of preoperative anaemia in order to optimize perioperative outcomes. However, despite improvements in preoperative haemoglobin there exists a group of patients who develop worsening or recurrent anaemia in the post-operative period. Without intervention up to 90% of patients in the immediate postoperative period may develop anaemia. This is not unexpected given the peri-operative blood loss; poor nutritional intake in the postoperative period; and the frequent blood sampling for laboratory tests. Our data from previous trials has demonstrated that despite preoperative intravenous iron therapy 75% of patients remain anaemic at the time of their colorectal cancer operation. In addition, our unpublished data has found that around 1/3 of patients treated with preoperative iron therapy develop a recurrence of their anaemia in the first year postoperatively. Studies have identified that traditional oral ferrous iron supplementation is largely ineffective for the treatment of postoperative anaemia. However, a newer oral iron preparation - ferric maltol (Ferracru) has been found to be better tolerated and more efficacious than ferrous iron. This study aims to evaluate whether the use of iron supplementation in the form of Feraccru could lead to a more sustained or improved a response in haemoglobin if given after a colorectal cancer operation. Improving this postoperative anaemia may have important implications for clinician and patient reported outcomes. The Perioperative Iron in Colorectal Cancer (PICoC) trial will run as a feasibility study to assess the proposed design, recruitability and outcome measures. Anaemic colorectal cancer patients treated with preoperative intravenous iron will be randomised in an open label design to receive a course of Ferric maltol (intervention group) or standard care (control group) postoperatively. Secondary outcome measures will focus on a comparison of change in blood indices, quality of life, allogenic red blood transfusion rates and postoperative complications between groups. Follow up will continue until the first postoperative outpatient visit at approximately 12 weeks following discharge.
Interventions
The intervention group will commence a course of oral ferric maltol provided oral intake has recommenced and the control group will receive standard care. All patients will have blood tests checked again at day 3 and day 5 postoperatively if they remain as an inpatient. If they are found to be anaemic on either of these two blood tests they will, at this stage, enter their allocated treatment pathway. If a patient shows no evidence of anaemia on either day 2, 3 or 5 blood tests they will be withdrawn from the study. Patients will continue treatment according to their randomisation allocation until 12 weeks after the operation, at which point the patient attends a routine surgical outpatient follow-up clinic. During the outpatient visit the participants will undergo their final blood testing and questionnaire completion.
Sponsors
The Royal Wolverhampton Hospitals NHS Trust
Norgine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant is willing and able to give informed consent for participation in the study. * Male or Female, aged 18+ years. * Diagnosed with histologically or radiologically diagnosed colorectal adenocarcinoma. * Anaemic at point of diagnosis of colorectal adenocarcinoma (Defined as haemoglobin 10g/L below WHO criteria: 120g/L for males and 110g/L for females, to account for a 10% fluctuation in Hb) * Undergoing surgery for colorectal cancer with curative intent. * Date of planned surgery is ≥ 14 days from date of planned initiation of recruitment. * Able (in the investigators opinion) and willing to comply with all study requirements. * Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.
Exclusion criteria
* Patients who do not have a histological diagnosis of colorectal adenocarcinoma * Female participants who are pregnant, lactating or planning a pregnancy during the course of the study. * Patients with evidence of iron overload or disturbances in utilisation of iron as stated in the product SPC. * Previous gastric, small bowel or colorectal surgery (where ≥50% of stomach or terminal ileum has been resected) * Chemotherapeutic treatment within the last 4 weeks. * Known previous anaemia not attributable to colorectal carcinoma (i.e. anaemia in patients with well established, inflammatory disorders) * Known haematological disease. * Features necessitating urgent surgery (e.g. obstructive symptoms). * Previous allergy to intravenous or oral iron or related iron products. * Patients who are unable to consent. * Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study. * Participants who have participated in another research study involving an investigational product in the past 12 weeks * Confirmed liver or lung metastases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Feasibility of Running the Study, to See if it Could be Run as a Large Multi-centre Study | 1 year | Feasibility measures will include the number of patients: * Eligible from screening * excluded and why * will stay in the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Levels of Haemoglobin and Haematinic Markers (Full Blood Count, Ferritin, Iron, Transferrin, and Transferrin Saturation) | Diagnosis (Baseline), recruitment (at Enrollment), day of surgery (between 2 weeks - 2 months from recruitment), POD2 (2 days post op), POD3 (3 days post op), POD5 (5 days post op), discharge (5 days post op), and follow up (up to 12 weeks) | Haemoglobin (Hb) was measured at several timepoints across the study period. |
| Haematinics (Iron Studies) | Recruitment (at Enrollment), day of surgery (between 2 weeks - 2 months from recruitment), POD5 (5 days post op), and follow up (up to 12 weeks) | Iron studies, including total serum iron level, TIBC, transferrin, and transferrin saturation, are essential for diagnosing patients suspected of iron deficiency and overload. Results demonstrated that the Ferric Maltol has improved patents' iron stores. |
| CRP | Recruitment (at Enrollment), day of surgery (between 2 weeks - 2 months from recruitment), POD2 (2 days post op), POD3 (3 days post op), POD5 (5 days post op), and follow up (up to 12 weeks) | We looked at the CRP at the different timepoints |
| Side Effects to Ferric Maltol Administration | 1 year | An aspect of the safety and feasibility of the study was the tolerability of ferric maltol amongst post-operative colorectal cancer patients. We recorded any reported symptoms patient experienced as potential side effects. |
| Adherence to Treatment | 1 year | Patients adherence to treatment - if they took their tablets. Both arms are not included as the standard care group did not take Ferric Maltol. |
| Complications | 1 year | Differences in rates of complications between the two groups. |
| Mortality | 12 weeks | Analysis was using Fisher's exact test due to the small sample size, this is approximately 90-day mortality as patients were followed for approximately 12 weeks. |
| Length of Hospital Stay | 1 year | Analysing the length of hospital stay of patients in the two groups. |
| Readmission | 1 year | Rates of readmission between the two groups. |
| Allogenic Blood Transfusion | 1 year | Patients who required blood transfusion during the trial period. |
| Grip Strength | Recruitment (at Enrollment), day of surgery (between 2 weeks - 2 months from recruitment), POD2 (2 days post op), POD3 (3 days post op), POD5 (5 days post op), and follow up (12 weeks) | Assessed the patients grip strength throughout their perioperative journey. |
Countries
United Kingdom
Contacts
PRINCIPAL_INVESTIGATORNuha Yassin
The Royal Wolverhampton NHS Trust
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ferric Maltol oral ferric maltol: The intervention group will commence a course of oral ferric maltol provided oral intake has recommenced and the control group will receive standard care. All patients will have blood tests checked again at day 3 and day 5 postoperatively if they remain as an inpatient. If they are found to be anaemic on either of these two blood tests they will, at this stage, enter their allocated treatment pathway. If a patient shows no evidence of anaemia on either day 2, 3 or 5 blood tests they will be withdrawn from the study. Patients will continue treatment according to their randomisation allocation until 12 weeks after the operation, at which point the patient attends a routine surgical outpatient follow-up clinic. During the outpatient visit the participants will undergo their final blood testing and questionnaire completion. | 20 |
| Standard Care Standard post-operative care | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Ferric Maltol | Standard Care | Total |
|---|---|---|---|
| Age, Continuous | 74.30 years | 73.5 years | 73.9 years |
| Race/Ethnicity, Customized Ethnicity Black British (Caribbean) | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Ethnicity South Asian | 2 Participants | 3 Participants | 5 Participants |
| Race/Ethnicity, Customized Ethnicity White British | 17 Participants | 17 Participants | 34 Participants |
| Sex: Female, Male Female | 8 Participants | 8 Participants | 16 Participants |
| Sex: Female, Male Male | 12 Participants | 12 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 16 | 0 / 18 |
| other Total, other adverse events | 4 / 16 | 3 / 18 |
| serious Total, serious adverse events | 6 / 16 | 4 / 18 |
Outcome results
Primary
The Feasibility of Running the Study, to See if it Could be Run as a Large Multi-centre Study
Feasibility measures will include the number of patients: * Eligible from screening * excluded and why * will stay in the study
Time frame: 1 year
Population: A total of 42 patients were recruited to the study. There were 2 patients who were withdrawn prior to randomisation. Of those 40 patients randomised 32 patients remained in the study to analysis, this was 80%.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ferric Maltol | The Feasibility of Running the Study, to See if it Could be Run as a Large Multi-centre Study | 16 participants |
| Standard Care | The Feasibility of Running the Study, to See if it Could be Run as a Large Multi-centre Study | 18 participants |
Secondary
Adherence to Treatment
Patients adherence to treatment - if they took their tablets. Both arms are not included as the standard care group did not take Ferric Maltol.
Time frame: 1 year
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ferric Maltol | Adherence to Treatment | All of tablets taken | 11 Participants |
| Ferric Maltol | Adherence to Treatment | Most of tablets taken | 2 Participants |
| Ferric Maltol | Adherence to Treatment | Some of tablets taken | 1 Participants |
| Ferric Maltol | Adherence to Treatment | Few of tablets taken | 1 Participants |
Secondary
Allogenic Blood Transfusion
Patients who required blood transfusion during the trial period.
Time frame: 1 year
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ferric Maltol | Allogenic Blood Transfusion | Pre-operative and intra-operative Transfusion | 3 Participants |
| Ferric Maltol | Allogenic Blood Transfusion | Post-operative Transfusion (During admission) | 1 Participants |
| Ferric Maltol | Allogenic Blood Transfusion | Post-operative Transfusion (Following Discharge) | 0 Participants |
| Standard Care | Allogenic Blood Transfusion | Pre-operative and intra-operative Transfusion | 1 Participants |
| Standard Care | Allogenic Blood Transfusion | Post-operative Transfusion (During admission) | 1 Participants |
| Standard Care | Allogenic Blood Transfusion | Post-operative Transfusion (Following Discharge) | 1 Participants |
Secondary
Complications
Differences in rates of complications between the two groups.
Time frame: 1 year
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ferric Maltol | Complications | Complications | 8 Participants |
| Ferric Maltol | Complications | No complications | 7 Participants |
| Standard Care | Complications | Complications | 9 Participants |
| Standard Care | Complications | No complications | 8 Participants |
Secondary
CRP
We looked at the CRP at the different timepoints
Time frame: Recruitment (at Enrollment), day of surgery (between 2 weeks - 2 months from recruitment), POD2 (2 days post op), POD3 (3 days post op), POD5 (5 days post op), and follow up (up to 12 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ferric Maltol | CRP | Recruitment | 13.29 mg/dl | Standard Deviation 25.65 |
| Ferric Maltol | CRP | Day of surgery | 11.9 mg/dl | Standard Deviation 21.3 |
| Ferric Maltol | CRP | POD2 | 137.8 mg/dl | Standard Deviation 94.48 |
| Ferric Maltol | CRP | POD3 | 156.8 mg/dl | Standard Deviation 101.49 |
| Ferric Maltol | CRP | POD5 | 114.4 mg/dl | Standard Deviation 104.32 |
| Ferric Maltol | CRP | Follow up | 4.571 mg/dl | Standard Deviation 5.96 |
| Standard Care | CRP | POD5 | 89.6 mg/dl | Standard Deviation 94.76 |
| Standard Care | CRP | Recruitment | 11.8 mg/dl | Standard Deviation 13.91 |
| Standard Care | CRP | POD3 | 136.83 mg/dl | Standard Deviation 99.1 |
| Standard Care | CRP | Day of surgery | 12.55 mg/dl | Standard Deviation 14.98 |
| Standard Care | CRP | Follow up | 5.278 mg/dl | Standard Deviation 8.46 |
| Standard Care | CRP | POD2 | 145.85 mg/dl | Standard Deviation 74.62 |
Secondary
Grip Strength
Assessed the patients grip strength throughout their perioperative journey.
Time frame: Recruitment (at Enrollment), day of surgery (between 2 weeks - 2 months from recruitment), POD2 (2 days post op), POD3 (3 days post op), POD5 (5 days post op), and follow up (12 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ferric Maltol | Grip Strength | Recruitment | 23.0868421 kg | Standard Deviation 8.49509404 |
| Ferric Maltol | Grip Strength | Day of Surgery | 23.2763158 kg | Standard Deviation 9.41755701 |
| Ferric Maltol | Grip Strength | POD2 | 20 kg | Standard Deviation 9.21453455 |
| Ferric Maltol | Grip Strength | POD3 | 20.2447368 kg | Standard Deviation 9.30052111 |
| Ferric Maltol | Grip Strength | POD5 | 20.471875 kg | Standard Deviation 9.5833183 |
| Ferric Maltol | Grip Strength | Follow up | 22.7846154 kg | Standard Deviation 10.3199117 |
| Standard Care | Grip Strength | POD5 | 22.2052632 kg | Standard Deviation 10.0175526 |
| Standard Care | Grip Strength | Recruitment | 23.6342105 kg | Standard Deviation 11.4668369 |
| Standard Care | Grip Strength | POD3 | 23.01 kg | Standard Deviation 10.9261351 |
| Standard Care | Grip Strength | Day of Surgery | 24.84 kg | Standard Deviation 10.6813364 |
| Standard Care | Grip Strength | Follow up | 24.2944444 kg | Standard Deviation 9.77469556 |
| Standard Care | Grip Strength | POD2 | 21.55 kg | Standard Deviation 9.28184502 |
Secondary
Haematinics (Iron Studies)
Iron studies, including total serum iron level, TIBC, transferrin, and transferrin saturation, are essential for diagnosing patients suspected of iron deficiency and overload. Results demonstrated that the Ferric Maltol has improved patents' iron stores.
Time frame: Recruitment (at Enrollment), day of surgery (between 2 weeks - 2 months from recruitment), POD5 (5 days post op), and follow up (up to 12 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ferric Maltol | Haematinics (Iron Studies) | Iron at recruitment | 8.445 mmol/l | Standard Deviation 11.8 |
| Ferric Maltol | Haematinics (Iron Studies) | Iron at day of surgery | 13.68 mmol/l | Standard Deviation 8.349 |
| Ferric Maltol | Haematinics (Iron Studies) | Iron on POD5 | 6.938 mmol/l | Standard Deviation 5.302 |
| Ferric Maltol | Haematinics (Iron Studies) | Iron follow up | 15.69 mmol/l | Standard Deviation 8.931 |
| Ferric Maltol | Haematinics (Iron Studies) | Transferrin at recruitment | 3.045 mmol/l | Standard Deviation 0.47 |
| Ferric Maltol | Haematinics (Iron Studies) | Transferrin at day of surgery | 2.355 mmol/l | Standard Deviation 0.397 |
| Ferric Maltol | Haematinics (Iron Studies) | Transferrin on POD5 | 1.66 mmol/l | Standard Deviation 0.411 |
| Ferric Maltol | Haematinics (Iron Studies) | Transferrin follow up | 2.337 mmol/l | Standard Deviation 0.429 |
| Ferric Maltol | Haematinics (Iron Studies) | T.Sats at recruitment | 11.49 mmol/l | Standard Deviation 15.8 |
| Ferric Maltol | Haematinics (Iron Studies) | T.Sats at day of surgery | 23.18 mmol/l | Standard Deviation 13.593 |
| Ferric Maltol | Haematinics (Iron Studies) | T.Sats on POD5 | 16.46 mmol/l | Standard Deviation 11.31 |
| Ferric Maltol | Haematinics (Iron Studies) | T.Sats follow up | 26.63 mmol/l | Standard Deviation 14.305 |
| Ferric Maltol | Haematinics (Iron Studies) | TIBC at recruitment | 75.91 mmol/l | Standard Deviation 10.97 |
| Ferric Maltol | Haematinics (Iron Studies) | TIBC at day of surgery | 59.11 mmol/l | Standard Deviation 9.942 |
| Ferric Maltol | Haematinics (Iron Studies) | TIBC on POD5 | 41.68 mmol/l | Standard Deviation 10.308 |
| Ferric Maltol | Haematinics (Iron Studies) | TIBC follow up | 58.65 mmol/l | Standard Deviation 10.769 |
| Standard Care | Haematinics (Iron Studies) | TIBC follow up | 67.81 mmol/l | Standard Deviation 13.712 |
| Standard Care | Haematinics (Iron Studies) | Iron at recruitment | 6.86 mmol/l | Standard Deviation 5.79 |
| Standard Care | Haematinics (Iron Studies) | T.Sats at recruitment | 9.89 mmol/l | Standard Deviation 9.5 |
| Standard Care | Haematinics (Iron Studies) | Iron at day of surgery | 11.52 mmol/l | Standard Deviation 8.9 |
| Standard Care | Haematinics (Iron Studies) | TIBC at recruitment | 74.21 mmol/l | Standard Deviation 14.14 |
| Standard Care | Haematinics (Iron Studies) | Iron on POD5 | 7.328 mmol/l | Standard Deviation 4.546 |
| Standard Care | Haematinics (Iron Studies) | T.Sats at day of surgery | 18.16 mmol/l | Standard Deviation 12.303 |
| Standard Care | Haematinics (Iron Studies) | Iron follow up | 12.97 mmol/l | Standard Deviation 6.662 |
| Standard Care | Haematinics (Iron Studies) | TIBC on POD5 | 47.29 mmol/l | Standard Deviation 11.191 |
| Standard Care | Haematinics (Iron Studies) | Transferrin at recruitment | 3.09 mmol/l | Standard Deviation 0.74 |
| Standard Care | Haematinics (Iron Studies) | T.Sats on POD5 | 15.64 mmol/l | Standard Deviation 8.669 |
| Standard Care | Haematinics (Iron Studies) | Transferrin at day of surgery | 4.265 mmol/l | Standard Deviation 7.701 |
| Standard Care | Haematinics (Iron Studies) | TIBC at day of surgery | 62.63 mmol/l | Standard Deviation 12.656 |
| Standard Care | Haematinics (Iron Studies) | Transferrin on POD5 | 2.893 mmol/l | Standard Deviation 3.028 |
| Standard Care | Haematinics (Iron Studies) | T.Sats follow up | 19.84 mmol/l | Standard Deviation 9.846 |
| Standard Care | Haematinics (Iron Studies) | Transferrin follow up | 2.705 mmol/l | Standard Deviation 0.553 |
Secondary
Length of Hospital Stay
Analysing the length of hospital stay of patients in the two groups.
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ferric Maltol | Length of Hospital Stay | 7.133 Days | Standard Deviation 4.809 |
| Standard Care | Length of Hospital Stay | 7.333 Days | Standard Deviation 6.202 |
Secondary
Levels of Haemoglobin and Haematinic Markers (Full Blood Count, Ferritin, Iron, Transferrin, and Transferrin Saturation)
Haemoglobin (Hb) was measured at several timepoints across the study period.
Time frame: Diagnosis (Baseline), recruitment (at Enrollment), day of surgery (between 2 weeks - 2 months from recruitment), POD2 (2 days post op), POD3 (3 days post op), POD5 (5 days post op), discharge (5 days post op), and follow up (up to 12 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ferric Maltol | Levels of Haemoglobin and Haematinic Markers (Full Blood Count, Ferritin, Iron, Transferrin, and Transferrin Saturation) | Hb at Diagnosis | 87 g/l | Standard Deviation 15.2 |
| Ferric Maltol | Levels of Haemoglobin and Haematinic Markers (Full Blood Count, Ferritin, Iron, Transferrin, and Transferrin Saturation) | Hb at Recruitment | 106.4 g/l | Standard Deviation 16.5 |
| Ferric Maltol | Levels of Haemoglobin and Haematinic Markers (Full Blood Count, Ferritin, Iron, Transferrin, and Transferrin Saturation) | AHb at Day of Surgery | 116.7 g/l | Standard Deviation 16.1 |
| Ferric Maltol | Levels of Haemoglobin and Haematinic Markers (Full Blood Count, Ferritin, Iron, Transferrin, and Transferrin Saturation) | Hb on POD2 | 104.1 g/l | Standard Deviation 19.6 |
| Ferric Maltol | Levels of Haemoglobin and Haematinic Markers (Full Blood Count, Ferritin, Iron, Transferrin, and Transferrin Saturation) | Hb on POD3 | 108.8 g/l | Standard Deviation 16.7 |
| Ferric Maltol | Levels of Haemoglobin and Haematinic Markers (Full Blood Count, Ferritin, Iron, Transferrin, and Transferrin Saturation) | Hb on POD5 | 103.9 g/l | Standard Deviation 15.4 |
| Ferric Maltol | Levels of Haemoglobin and Haematinic Markers (Full Blood Count, Ferritin, Iron, Transferrin, and Transferrin Saturation) | Hb on Discharge | 98.9 g/l | Standard Deviation 13.4 |
| Ferric Maltol | Levels of Haemoglobin and Haematinic Markers (Full Blood Count, Ferritin, Iron, Transferrin, and Transferrin Saturation) | Hb Follow Up | 129.7 g/l | Standard Deviation 19.8 |
| Standard Care | Levels of Haemoglobin and Haematinic Markers (Full Blood Count, Ferritin, Iron, Transferrin, and Transferrin Saturation) | Hb Follow Up | 128.1 g/l | Standard Deviation 12.8 |
| Standard Care | Levels of Haemoglobin and Haematinic Markers (Full Blood Count, Ferritin, Iron, Transferrin, and Transferrin Saturation) | Hb at Diagnosis | 93.55 g/l | Standard Deviation 16.01 |
| Standard Care | Levels of Haemoglobin and Haematinic Markers (Full Blood Count, Ferritin, Iron, Transferrin, and Transferrin Saturation) | Hb on POD3 | 106.3 g/l | Standard Deviation 12.2 |
| Standard Care | Levels of Haemoglobin and Haematinic Markers (Full Blood Count, Ferritin, Iron, Transferrin, and Transferrin Saturation) | Hb at Recruitment | 105 g/l | Standard Deviation 16.7 |
| Standard Care | Levels of Haemoglobin and Haematinic Markers (Full Blood Count, Ferritin, Iron, Transferrin, and Transferrin Saturation) | Hb on Discharge | 106.2 g/l | Standard Deviation 10.9 |
| Standard Care | Levels of Haemoglobin and Haematinic Markers (Full Blood Count, Ferritin, Iron, Transferrin, and Transferrin Saturation) | AHb at Day of Surgery | 116.2 g/l | Standard Deviation 15.9 |
| Standard Care | Levels of Haemoglobin and Haematinic Markers (Full Blood Count, Ferritin, Iron, Transferrin, and Transferrin Saturation) | Hb on POD5 | 104.4 g/l | Standard Deviation 10.46 |
| Standard Care | Levels of Haemoglobin and Haematinic Markers (Full Blood Count, Ferritin, Iron, Transferrin, and Transferrin Saturation) | Hb on POD2 | 104.0 g/l | Standard Deviation 12.4 |
Secondary
Mortality
Analysis was using Fisher's exact test due to the small sample size, this is approximately 90-day mortality as patients were followed for approximately 12 weeks.
Time frame: 12 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ferric Maltol | Mortality | Death | 1 Participants |
| Ferric Maltol | Mortality | Alive | 14 Participants |
| Standard Care | Mortality | Death | 0 Participants |
| Standard Care | Mortality | Alive | 16 Participants |
Secondary
Readmission
Rates of readmission between the two groups.
Time frame: 1 year
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ferric Maltol | Readmission | Readmission | 2 Participants |
| Ferric Maltol | Readmission | No readmission | 14 Participants |
| Standard Care | Readmission | Readmission | 1 Participants |
| Standard Care | Readmission | No readmission | 16 Participants |
Secondary
Side Effects to Ferric Maltol Administration
An aspect of the safety and feasibility of the study was the tolerability of ferric maltol amongst post-operative colorectal cancer patients. We recorded any reported symptoms patient experienced as potential side effects.
Time frame: 1 year
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ferric Maltol | Side Effects to Ferric Maltol Administration | No side effects | 10 Participants |
| Ferric Maltol | Side Effects to Ferric Maltol Administration | Side effects | 5 Participants |
| Standard Care | Side Effects to Ferric Maltol Administration | No side effects | 11 Participants |
| Standard Care | Side Effects to Ferric Maltol Administration | Side effects | 6 Participants |