Measures to Increase the Effectiveness of Fast Track Colorectal Clinics for Iron Deficiency Anaemia.

June 18, 2019 updated by: Mr Talal Majeed, Wirral University Teaching Hospital NHS Trust

Establishing Absolute Iron Deficiency Anaemia Before Referring Patients to Colorectal Fast Track Clinics Can Help to Increase the Diagnostic Yield of the Bowel Cancer Screening Programme.

A retrospective cohort study was conducted from 2016-18 in a single busy district general hospital providing services to a population of 700,000 people.

In the study, patients with true IDA (low MCV and ferritin) were found to be more likely to have Colorectal cancer compared to any other type of anaemia which confirmed the latest guidelines for management of IDA. Compared to symptoms, only the presence of a mass on abdominal examination and rectal examination was found to be more likely associated with cancer.

Study Overview

Detailed Description

Although there are strict and specific guidelines for referring patients with iron deficiency anaemia (IDA) to fast track colorectal cancer (FT CRC) clinics for further assessment and investigation, patients with other types of anaemia are still referred by primary care physicians in the UK. Investigators aim was to find out whether this practice is correct, or if it is causing an overburden on colorectal clinics and endoscopy services. Investigators also want to find out whether true/absolute IDA has a higher predictive value for diagnosing colorectal cancer (CRC) compared to other types of anaemia and specific bowel symptoms.

Investigator's hypothesis was that patients with IDA are more likely to have CRC compared to patients with no anaemia or non-IDA anaemia. By confirming this hypothesis, Investigators can identify high risk patients from the population who can then be preferentially subjected to investigations mandated by guidelines. This strategy can help to increase the diagnostic yield of FT CRC clinics.

A retrospective cohort study was conducted from 2016-18 in a single busy district general hospital providing services to a population of 700,000 people.

In the study, patients with true IDA (low MCV and ferritin) were found to be more likely to have CRC compared to any other type of anaemia which confirmed the latest guidelines for management of IDA. Compared to symptoms, only the presence of a mass on abdominal examination and rectal examination was found to be more likely associated with cancer.

Physicians should be able to stratify patients based on blood indices when referring them to FT CRC clinics. Diagnostic yield of these clinics can be increased if clinicians strictly adhere to fast track guidelines and confirm true IDA before referring patients to clinic.

Study Type

Observational

Enrollment (Actual)

950

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Yorkshire
      • York, Yorkshire, United Kingdom, YO31 8HE
        • York Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This was a retrospective observational study from a busy district general hospital. A retrospective analysis of prospectively maintained data for FT CRC was performed. Data was selected from 2016-18. A cohort of 4177 patients presented to FT clinics. Among them 950 (22.74%) patients were referred with anaemia

Description

Inclusion Criteria:

- Patients with age more than 18 years Presenting to fast track colorectal clinic

  1. With bowel symptoms
  2. Presenting with anaemia
  3. Rectal bleeding

Exclusion Criteria:

  • Any patient presenting through routine colorectal clinics

    1. With bowel symptoms
    2. Presenting with anaemia
    3. Rectal bleeding Aged less than 18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Iron deficiency anaemia with bowel symptoms
Patients with IDA presenting with bowel symptoms like change in bowel habits, weight loss and abdominal mass other than rectal bleed
Patients referred with a suspected bowel malignancy were subjected to top and bottom endoscopic examination or a cross sectional imaging like CT scan and MRI scan.
Iron deficiency anaemia with no bowel symptoms
Patients with IDA with no bowel symptoms
Patients referred with a suspected bowel malignancy were subjected to top and bottom endoscopic examination or a cross sectional imaging like CT scan and MRI scan.
Iron deficiency anaemia with rectal bleeding
Patients with IDA and rectal bleeding
Patients referred with a suspected bowel malignancy were subjected to top and bottom endoscopic examination or a cross sectional imaging like CT scan and MRI scan.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic yield of colorectal cancer
Time Frame: 2 weeks
diagnostic yield of colorectal cancer in patients presenting to fast track clinics with symptomatic ,asymptomatic anaemia, anaemia with normal blood indices, anaemia with Iron deficiency anaemia and certain bowel symptoms was measured. Patients were subjected to endoscopy for diagnosis. Diagnostic yield was expressed as diagnostic odds ratio and measured by statistical tools like Mantel Haenszel trend test and results are illustrated in the from of odds ratio. Crude odds ratio could not be used as association of binary outcome (colorectal caner or no cancer) with binary predictors in multiple case control groups was assessed.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: TALAL MAJEED, MRCS, Mr Talal Majeed

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2018

Primary Completion (Actual)

August 3, 2018

Study Completion (Actual)

February 12, 2019

Study Registration Dates

First Submitted

June 6, 2019

First Submitted That Met QC Criteria

June 13, 2019

First Posted (Actual)

June 17, 2019

Study Record Updates

Last Update Posted (Actual)

June 20, 2019

Last Update Submitted That Met QC Criteria

June 18, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

I have an excel sheet of the data and statistics done on the data which can be provided on request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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