Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03988712
Recruitment Status : Completed
First Posted : June 17, 2019
Last Update Posted : June 20, 2019
Sponsor:
Information provided by (Responsible Party):
Mr Talal Majeed, Wirral University Teaching Hospital NHS Trust

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.


Condition or disease Intervention/treatment
Colorectal Cancer Diagnostic Test: Colonoscopy, gastroscopy, virtual colonoscopy, CT scan

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.


Layout table for study information
Study Type : Observational
Actual Enrollment : 950 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: 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.
Actual Study Start Date : April 1, 2018
Actual Primary Completion Date : August 3, 2018
Actual Study Completion Date : February 12, 2019

Resource links provided by the National Library of Medicine


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
Diagnostic Test: 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.

Iron deficiency anaemia with no bowel symptoms
Patients with IDA with no bowel symptoms
Diagnostic Test: 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.

Iron deficiency anaemia with rectal bleeding
Patients with IDA and rectal bleeding
Diagnostic Test: 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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03988712


Locations
Layout table for location information
United Kingdom
York Hospital
York, Yorkshire, United Kingdom, YO31 8HE
Sponsors and Collaborators
Wirral University Teaching Hospital NHS Trust
Investigators
Layout table for investigator information
Principal Investigator: TALAL MAJEED, MRCS Mr Talal Majeed

Layout table for additonal information
Responsible Party: Mr Talal Majeed, Research Fellow, Wirral University Teaching Hospital NHS Trust
ClinicalTrials.gov Identifier: NCT03988712     History of Changes
Other Study ID Numbers: 161130
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: I have an excel sheet of the data and statistics done on the data which can be provided on request

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mr Talal Majeed, Wirral University Teaching Hospital NHS Trust:
Anaemia
colorectal cancer
Iron deficiency anaemia

Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Intestinal Diseases
Anemia
Anemia, Iron-Deficiency
Digestive System Diseases
Gastrointestinal Diseases
Rectal Diseases
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Iron
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs