Trial Outcomes & Findings for Perioperative Iron for Colorectal Cancer (PICoC Study) (NCT NCT05177484)
NCT ID: NCT05177484
Last Updated: 2026-01-30
Results Overview
Feasibility measures will include the number of patients: * Eligible from screening * excluded and why * will stay in the study
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
40 participants
Primary outcome timeframe
1 year
Results posted on
2026-01-30
Participant Flow
Participant milestones
| Measure |
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 If a patient shows no evidence of anaemia on either day 2, 3 or 5 blood tests they will be withdrawn from the study.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.
|
Standard Care
Standard post-operative care
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
16
|
18
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
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 If a patient shows no evidence of anaemia on either day 2, 3 or 5 blood tests they will be withdrawn from the study.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.
|
Standard Care
Standard post-operative care
|
|---|---|---|
|
Overall Study
Withdrawn as not anaemic post operatively
|
1
|
0
|
|
Overall Study
Inadvertently withdrawn
|
3
|
1
|
|
Overall Study
Withdrawn as not given standard care, given IV iron
|
0
|
1
|
Baseline Characteristics
Perioperative Iron for Colorectal Cancer (PICoC Study)
Baseline characteristics by cohort
| Measure |
Ferric Maltol
n=20 Participants
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.
|
Standard Care
n=20 Participants
Standard post-operative care
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
74.30 years
n=41 Participants
|
73.5 years
n=1581 Participants
|
73.9 years
n=4626 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=41 Participants
|
8 Participants
n=1581 Participants
|
16 Participants
n=4626 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=41 Participants
|
12 Participants
n=1581 Participants
|
24 Participants
n=4626 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · White British
|
17 Participants
n=41 Participants
|
17 Participants
n=1581 Participants
|
34 Participants
n=4626 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · South Asian
|
2 Participants
n=41 Participants
|
3 Participants
n=1581 Participants
|
5 Participants
n=4626 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Black British (Caribbean)
|
1 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: 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%.
Feasibility measures will include the number of patients: * Eligible from screening * excluded and why * will stay in the study
Outcome measures
| Measure |
Standard Care
n=21 Participants
Standard post-operative care
|
Ferric Maltol
n=21 Participants
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.
|
|---|---|---|
|
The Feasibility of Running the Study, to See if it Could be Run as a Large Multi-centre Study
|
18 participants
|
16 participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Standard Care
n=18 Participants
Standard post-operative care
|
Ferric Maltol
n=16 Participants
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.
|
|---|---|---|
|
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
|
87 g/l
Standard Deviation 15.2
|
|
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
|
106.4 g/l
Standard Deviation 16.5
|
|
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
|
116.7 g/l
Standard Deviation 16.1
|
|
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
|
104.1 g/l
Standard Deviation 19.6
|
|
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
|
108.8 g/l
Standard Deviation 16.7
|
|
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
|
103.9 g/l
Standard Deviation 15.4
|
|
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
|
98.9 g/l
Standard Deviation 13.4
|
|
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
|
129.7 g/l
Standard Deviation 19.8
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Standard Care
n=18 Participants
Standard post-operative care
|
Ferric Maltol
n=16 Participants
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.
|
|---|---|---|
|
Haematinics (Iron Studies)
Iron at recruitment
|
6.86 mmol/l
Standard Deviation 5.790
|
8.445 mmol/l
Standard Deviation 11.800
|
|
Haematinics (Iron Studies)
Iron at day of surgery
|
11.52 mmol/l
Standard Deviation 8.900
|
13.68 mmol/l
Standard Deviation 8.349
|
|
Haematinics (Iron Studies)
Iron on POD5
|
7.328 mmol/l
Standard Deviation 4.546
|
6.938 mmol/l
Standard Deviation 5.302
|
|
Haematinics (Iron Studies)
Iron follow up
|
12.97 mmol/l
Standard Deviation 6.662
|
15.69 mmol/l
Standard Deviation 8.931
|
|
Haematinics (Iron Studies)
Transferrin at recruitment
|
3.09 mmol/l
Standard Deviation 0.740
|
3.045 mmol/l
Standard Deviation 0.470
|
|
Haematinics (Iron Studies)
Transferrin at day of surgery
|
4.265 mmol/l
Standard Deviation 7.701
|
2.355 mmol/l
Standard Deviation 0.397
|
|
Haematinics (Iron Studies)
Transferrin on POD5
|
2.893 mmol/l
Standard Deviation 3.028
|
1.66 mmol/l
Standard Deviation 0.411
|
|
Haematinics (Iron Studies)
T.Sats at recruitment
|
9.89 mmol/l
Standard Deviation 9.500
|
11.49 mmol/l
Standard Deviation 15.800
|
|
Haematinics (Iron Studies)
T.Sats at day of surgery
|
18.16 mmol/l
Standard Deviation 12.303
|
23.18 mmol/l
Standard Deviation 13.593
|
|
Haematinics (Iron Studies)
T.Sats on POD5
|
15.64 mmol/l
Standard Deviation 8.669
|
16.46 mmol/l
Standard Deviation 11.310
|
|
Haematinics (Iron Studies)
T.Sats follow up
|
19.84 mmol/l
Standard Deviation 9.846
|
26.63 mmol/l
Standard Deviation 14.305
|
|
Haematinics (Iron Studies)
TIBC at recruitment
|
74.21 mmol/l
Standard Deviation 14.140
|
75.91 mmol/l
Standard Deviation 10.970
|
|
Haematinics (Iron Studies)
TIBC at day of surgery
|
62.63 mmol/l
Standard Deviation 12.656
|
59.11 mmol/l
Standard Deviation 9.942
|
|
Haematinics (Iron Studies)
TIBC on POD5
|
47.29 mmol/l
Standard Deviation 11.191
|
41.68 mmol/l
Standard Deviation 10.308
|
|
Haematinics (Iron Studies)
TIBC follow up
|
67.81 mmol/l
Standard Deviation 13.712
|
58.65 mmol/l
Standard Deviation 10.769
|
|
Haematinics (Iron Studies)
Transferrin follow up
|
2.705 mmol/l
Standard Deviation 0.553
|
2.337 mmol/l
Standard Deviation 0.4290
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Standard Care
n=18 Participants
Standard post-operative care
|
Ferric Maltol
n=16 Participants
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.
|
|---|---|---|
|
CRP
Recruitment
|
11.8 mg/dl
Standard Deviation 13.91
|
13.29 mg/dl
Standard Deviation 25.65
|
|
CRP
Day of surgery
|
12.55 mg/dl
Standard Deviation 14.98
|
11.9 mg/dl
Standard Deviation 21.30
|
|
CRP
POD2
|
145.85 mg/dl
Standard Deviation 74.62
|
137.8 mg/dl
Standard Deviation 94.48
|
|
CRP
POD3
|
136.83 mg/dl
Standard Deviation 99.10
|
156.8 mg/dl
Standard Deviation 101.49
|
|
CRP
POD5
|
89.6 mg/dl
Standard Deviation 94.76
|
114.4 mg/dl
Standard Deviation 104.32
|
|
CRP
Follow up
|
5.278 mg/dl
Standard Deviation 8.46
|
4.571 mg/dl
Standard Deviation 5.96
|
SECONDARY outcome
Timeframe: 1 yearAn 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.
Outcome measures
| Measure |
Standard Care
n=17 Participants
Standard post-operative care
|
Ferric Maltol
n=15 Participants
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.
|
|---|---|---|
|
Side Effects to Ferric Maltol Administration
No side effects
|
11 Participants
|
10 Participants
|
|
Side Effects to Ferric Maltol Administration
Side effects
|
6 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 1 yearPatients adherence to treatment - if they took their tablets. Both arms are not included as the standard care group did not take Ferric Maltol.
Outcome measures
| Measure |
Standard Care
Standard post-operative care
|
Ferric Maltol
n=15 Participants
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.
|
|---|---|---|
|
Adherence to Treatment
All of tablets taken
|
—
|
11 Participants
|
|
Adherence to Treatment
Most of tablets taken
|
—
|
2 Participants
|
|
Adherence to Treatment
Some of tablets taken
|
—
|
1 Participants
|
|
Adherence to Treatment
Few of tablets taken
|
—
|
1 Participants
|
SECONDARY outcome
Timeframe: 1 yearDifferences in rates of complications between the two groups.
Outcome measures
| Measure |
Standard Care
n=17 Participants
Standard post-operative care
|
Ferric Maltol
n=15 Participants
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.
|
|---|---|---|
|
Complications
Complications
|
9 Participants
|
8 Participants
|
|
Complications
No complications
|
8 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 12 weeksAnalysis 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.
Outcome measures
| Measure |
Standard Care
n=16 Participants
Standard post-operative care
|
Ferric Maltol
n=15 Participants
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.
|
|---|---|---|
|
Mortality
Death
|
0 Participants
|
1 Participants
|
|
Mortality
Alive
|
16 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 1 yearAnalysing the length of hospital stay of patients in the two groups.
Outcome measures
| Measure |
Standard Care
n=18 Participants
Standard post-operative care
|
Ferric Maltol
n=16 Participants
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.
|
|---|---|---|
|
Length of Hospital Stay
|
7.333 Days
Standard Deviation 6.202
|
7.133 Days
Standard Deviation 4.809
|
SECONDARY outcome
Timeframe: 1 yearRates of readmission between the two groups.
Outcome measures
| Measure |
Standard Care
n=17 Participants
Standard post-operative care
|
Ferric Maltol
n=16 Participants
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.
|
|---|---|---|
|
Readmission
Readmission
|
1 Participants
|
2 Participants
|
|
Readmission
No readmission
|
16 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 1 yearPatients who required blood transfusion during the trial period.
Outcome measures
| Measure |
Standard Care
n=3 Participants
Standard post-operative care
|
Ferric Maltol
n=4 Participants
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.
|
|---|---|---|
|
Allogenic Blood Transfusion
Pre-operative and intra-operative Transfusion
|
1 Participants
|
3 Participants
|
|
Allogenic Blood Transfusion
Post-operative Transfusion (During admission)
|
1 Participants
|
1 Participants
|
|
Allogenic Blood Transfusion
Post-operative Transfusion (Following Discharge)
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Standard Care
n=20 Participants
Standard post-operative care
|
Ferric Maltol
n=19 Participants
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.
|
|---|---|---|
|
Grip Strength
Recruitment
|
23.6342105 kg
Standard Deviation 11.4668369
|
23.0868421 kg
Standard Deviation 8.49509404
|
|
Grip Strength
Day of Surgery
|
24.84 kg
Standard Deviation 10.6813364
|
23.2763158 kg
Standard Deviation 9.41755701
|
|
Grip Strength
POD2
|
21.55 kg
Standard Deviation 9.28184502
|
20 kg
Standard Deviation 9.21453455
|
|
Grip Strength
POD3
|
23.01 kg
Standard Deviation 10.9261351
|
20.2447368 kg
Standard Deviation 9.30052111
|
|
Grip Strength
POD5
|
22.2052632 kg
Standard Deviation 10.0175526
|
20.471875 kg
Standard Deviation 9.5833183
|
|
Grip Strength
Follow up
|
24.2944444 kg
Standard Deviation 9.77469556
|
22.7846154 kg
Standard Deviation 10.3199117
|
Adverse Events
Ferric Maltol
Serious events: 6 serious events
Other events: 4 other events
Deaths: 1 deaths
Standard Care
Serious events: 4 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ferric Maltol
n=16 participants at risk
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.
|
Standard Care
n=18 participants at risk
Standard post-operative care
|
|---|---|---|
|
Gastrointestinal disorders
Hospital stay
|
6.2%
1/16 • Number of events 1 • Prior to randomisation, following discharge, during admission, post-operative. Through to study completion, over 19 months
|
0.00%
0/18 • Prior to randomisation, following discharge, during admission, post-operative. Through to study completion, over 19 months
|
|
Infections and infestations
Hospital stay
|
6.2%
1/16 • Number of events 1 • Prior to randomisation, following discharge, during admission, post-operative. Through to study completion, over 19 months
|
0.00%
0/18 • Prior to randomisation, following discharge, during admission, post-operative. Through to study completion, over 19 months
|
|
Cardiac disorders
Hospital stay
|
0.00%
0/16 • Prior to randomisation, following discharge, during admission, post-operative. Through to study completion, over 19 months
|
5.6%
1/18 • Number of events 1 • Prior to randomisation, following discharge, during admission, post-operative. Through to study completion, over 19 months
|
|
Infections and infestations
Readmission
|
6.2%
1/16 • Number of events 1 • Prior to randomisation, following discharge, during admission, post-operative. Through to study completion, over 19 months
|
0.00%
0/18 • Prior to randomisation, following discharge, during admission, post-operative. Through to study completion, over 19 months
|
|
Respiratory, thoracic and mediastinal disorders
Hospital stay
|
0.00%
0/16 • Prior to randomisation, following discharge, during admission, post-operative. Through to study completion, over 19 months
|
5.6%
1/18 • Number of events 1 • Prior to randomisation, following discharge, during admission, post-operative. Through to study completion, over 19 months
|
|
Blood and lymphatic system disorders
Readmission
|
0.00%
0/16 • Prior to randomisation, following discharge, during admission, post-operative. Through to study completion, over 19 months
|
5.6%
1/18 • Number of events 1 • Prior to randomisation, following discharge, during admission, post-operative. Through to study completion, over 19 months
|
|
Gastrointestinal disorders
Anastomotic Leak
|
6.2%
1/16 • Number of events 1 • Prior to randomisation, following discharge, during admission, post-operative. Through to study completion, over 19 months
|
0.00%
0/18 • Prior to randomisation, following discharge, during admission, post-operative. Through to study completion, over 19 months
|
|
Gastrointestinal disorders
Readmission
|
6.2%
1/16 • Number of events 1 • Prior to randomisation, following discharge, during admission, post-operative. Through to study completion, over 19 months
|
0.00%
0/18 • Prior to randomisation, following discharge, during admission, post-operative. Through to study completion, over 19 months
|
Other adverse events
| Measure |
Ferric Maltol
n=16 participants at risk
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.
|
Standard Care
n=18 participants at risk
Standard post-operative care
|
|---|---|---|
|
Investigations
Delirium
|
0.00%
0/16 • Prior to randomisation, following discharge, during admission, post-operative. Through to study completion, over 19 months
|
5.6%
1/18 • Number of events 1 • Prior to randomisation, following discharge, during admission, post-operative. Through to study completion, over 19 months
|
|
Surgical and medical procedures
Bleed
|
6.2%
1/16 • Number of events 1 • Prior to randomisation, following discharge, during admission, post-operative. Through to study completion, over 19 months
|
0.00%
0/18 • Prior to randomisation, following discharge, during admission, post-operative. Through to study completion, over 19 months
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/16 • Prior to randomisation, following discharge, during admission, post-operative. Through to study completion, over 19 months
|
5.6%
1/18 • Number of events 1 • Prior to randomisation, following discharge, during admission, post-operative. Through to study completion, over 19 months
|
|
Surgical and medical procedures
Oedema
|
6.2%
1/16 • Number of events 1 • Prior to randomisation, following discharge, during admission, post-operative. Through to study completion, over 19 months
|
0.00%
0/18 • Prior to randomisation, following discharge, during admission, post-operative. Through to study completion, over 19 months
|
|
Infections and infestations
Infection
|
0.00%
0/16 • Prior to randomisation, following discharge, during admission, post-operative. Through to study completion, over 19 months
|
5.6%
1/18 • Number of events 1 • Prior to randomisation, following discharge, during admission, post-operative. Through to study completion, over 19 months
|
|
Product Issues
Side effect of Ferric Maltol
|
6.2%
1/16 • Number of events 1 • Prior to randomisation, following discharge, during admission, post-operative. Through to study completion, over 19 months
|
0.00%
0/18 • Prior to randomisation, following discharge, during admission, post-operative. Through to study completion, over 19 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.2%
1/16 • Number of events 1 • Prior to randomisation, following discharge, during admission, post-operative. Through to study completion, over 19 months
|
0.00%
0/18 • Prior to randomisation, following discharge, during admission, post-operative. Through to study completion, over 19 months
|
Additional Information
Group Research Sponsorship Manager
Royal Wolverhampton NHS Trust
Phone: 01902
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place