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

NCT ID: NCT03988712

Last Updated: 2019-06-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 950 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2019-02-12

Brief Summary

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.

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.

Conditions

Colorectal Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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

Colonoscopy, gastroscopy, virtual colonoscopy, CT scan

Intervention Type: DIAGNOSTIC_TEST

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

Colonoscopy, gastroscopy, virtual colonoscopy, CT scan

Intervention Type: DIAGNOSTIC_TEST

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

Colonoscopy, gastroscopy, virtual colonoscopy, CT scan

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

Colonoscopy, gastroscopy, virtual colonoscopy, CT scan

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wirral University Teaching Hospital NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Mr Talal Majeed

Research Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

TALAL MAJEED, MRCS

Role: PRINCIPAL_INVESTIGATOR

Mr Talal Majeed

Locations

York Hospital

York, Yorkshire, United Kingdom

Countries

United Kingdom

Other Identifiers

161130

Identifier Type: -

Identifier Source: org_study_id