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Measures to Increase the Effectiveness of Fast Track Colorectal Clinics for Iron Deficiency Anaemia.
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 |
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 |
| 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 |
| 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.
|
- 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.
| 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 |
Inclusion Criteria:
- Patients with age more than 18 years Presenting to fast track colorectal clinic
- With bowel symptoms
- Presenting with anaemia
- Rectal bleeding
Exclusion Criteria:
-
Any patient presenting through routine colorectal clinics
- With bowel symptoms
- Presenting with anaemia
- Rectal bleeding Aged less than 18 years
| United Kingdom | |
| York Hospital | |
| York, Yorkshire, United Kingdom, YO31 8HE | |
| Principal Investigator: | TALAL MAJEED, MRCS | Mr Talal Majeed |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | June 6, 2019 | ||||
| First Posted Date | June 17, 2019 | ||||
| Last Update Posted Date | June 20, 2019 | ||||
| Actual Study Start Date | April 1, 2018 | ||||
| Actual Primary Completion Date | August 3, 2018 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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.
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| Original Primary Outcome Measures |
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| Change History | |||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures |
Early cancer detection rate [ Time Frame: 6 weeks ] Early cancer detection in patients with bowels symptoms
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Measures to Increase the Effectiveness of Fast Track Colorectal Clinics for Iron Deficiency Anaemia. | ||||
| 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. | ||||
| 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. |
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| 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. |
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| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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 | ||||
| Condition | Colorectal Cancer | ||||
| Intervention | 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.
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| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
950 | ||||
| Original Actual Enrollment | Same as current | ||||
| Actual Study Completion Date | February 12, 2019 | ||||
| Actual Primary Completion Date | August 3, 2018 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria: - Patients with age more than 18 years Presenting to fast track colorectal clinic
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | United Kingdom | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03988712 | ||||
| Other Study ID Numbers | 161130 | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Mr Talal Majeed, Wirral University Teaching Hospital NHS Trust | ||||
| Study Sponsor | Wirral University Teaching Hospital NHS Trust | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | Wirral University Teaching Hospital NHS Trust | ||||
| Verification Date | June 2019 | ||||
