A prospective randomised trial in order to determine the benefit of preoperative oral iron supplementation for patients undergoing elective colorectal cancer resection

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-003355-12-GB

Enrollment

Registered

2005-11-07

Start date

2005-09-06

Completion date

Unknown

Last updated

2020-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal cancer

Interventions

Trade Name: ferrous sulphate tablets BP 200mg Product Name: ferrous sulphate 200mg tablets Pharmaceutical Form: Tablet Other descriptive name: ferrous sulphate Concentration unit: mg milligram(s) Conc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria Age over 18 years Competent to give informed consent Colorectal cancer Curative elective surgery planned Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Exclusion criteria Stenosing or obstructed lesion (relative contra-indication to oral iron therapy) Declining to consent Patients already on oral iron therapy Patients requiring emergency surgery

Design outcomes

Primary

Measure	Time frame
Main Objective: 1.To determine whether giving iron tablets to patients for 2 weeks before a colorectal cancer operation prevents or reduces anaemia requiring blood transfusion. ;Secondary Objective: 1. To determine whether a high (200mg tds) or low dose (200mg od) of iron tablets has an influence on the effectiveness in preventing or reducing anaemia. 2. To determine whether a high (200mg tds) or low dose (200mg od) of iron tablets has an influence on the rate and severity of side effects (constipation, diarrhoea, nausea, upper abdominal pain) ;Primary end point(s): Primary endpoint: Blood transfusion requirement Secondary endpoints: Change in haemoglobin produced by oral iron supplements Side effect profile produced by oral iron supplements	—

Measure

Time frame

Main Objective: 1.To determine whether giving iron tablets to patients for 2 weeks before a colorectal cancer operation prevents or reduces anaemia requiring blood transfusion. ;Secondary Objective: 1. To determine whether a high (200mg tds) or low dose (200mg od) of iron tablets has an influence on the effectiveness in preventing or reducing anaemia. 2. To determine whether a high (200mg tds) or low dose (200mg od) of iron tablets has an influence on the rate and severity of side effects (constipation, diarrhoea, nausea, upper abdominal pain) ;Primary end point(s): Primary endpoint: Blood transfusion requirement Secondary endpoints: Change in haemoglobin produced by oral iron supplements Side effect profile produced by oral iron supplements

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026