A prospective randomised trial in order to determine the benefit of preoperative oral iron supplementation for patients undergoing elective colorectal cancer resectio
Phase 1
- Conditions
- Colorectal cancer
- Registration Number
- EUCTR2005-003355-12-GB
- Lead Sponsor
- niversity hospitals of Leicester NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 90
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
Stenosing or obstructed lesion (relative contra-indication to oral iron therapy)
Declining to consent
Patients already on oral iron therapy
Patients requiring emergency surgery
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br><br>;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.<br><br>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)<br>;Primary end point(s): Primary endpoint: Blood transfusion requirement<br><br>Secondary endpoints: Change in haemoglobin produced by oral iron supplements<br>Side effect profile produced by oral iron supplements<br>
- Secondary Outcome Measures
Name Time Method