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The study was never started due to lack of staff
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The main objective of this study is to offer and evaluate an interim triage approach for patients waiting for surveillance colonoscopies. This will reduce the waiting period and the psychological stressors for our patients and from a scientific point of view allow us to compare the yield of findings for each approach.
This study will randomize patients (with low-risk findings in the initial colonoscopy) waiting for a surveillance colonoscopy into a follow-up with either FIT, CT colonography or colonoscopy. This approach will speed up the time for an exam for our patients and allow us to gather important data on the yield of significant findings when using FIT vs CT colonography vs colonoscopy for the surveillance exam.
All patients with positive FIT or CT colonography results will undergo subsequent colonoscopy. 300 patients will be randomized to 1:1:1 into 3 groups:
Group 1: patients will undergo Colonoscopy, findings will be documented and their participation in the study will end there. The findings of the colonoscopy will be addressed according to the institution's guidelines.
Group 2 will undergo fit testing if the fit test is positive: patients will have a subsequent colonoscopy within 3 months. Findings will be documented and participation in the study will end there. The findings of the colonoscopy will be addressed according to our institution's guidelines. If Fit test is negative patient will leave the study and will have a follow-up colonoscopy in one year.
Group 3 will have CT colonography. If CTC is positive: patients will have a subsequent colonoscopy within 3 months. Findings will be documented and participation in the study will end there. The findings of the colonoscopy will be addressed according to our institution's guidelines. If CTC is negative for polypoid lesions, the patient will leave the study and will have a follow-up 5 years after with a control colonoscopy.
All CT colonography and FIT tests analysis for patients will be performed as per the standard of care. Patients with suspicious lesions in CT colonography and positive FIT results will be redirected for colonoscopy and prioritized as P3 (Meaning endoscopy has to be done within 3 months).
Polypectomy specimens will be sent for pathological examination according to the standard of care and institutional routine practice. Pathology results will be followed up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| a colonoscopy as surveillance exam | Active Comparator | patients will undergo Colonoscopy, finding will be documented. Findings of colonoscopy will be documented and treated according to the institutional standards. Study participation for patients ends after the colonoscopy and follow-up of pathology results and complication assessment. |
|
| undergoing a FIT as surveillance exam | Active Comparator | if the FIT test is positive: patients will have subsequent colonoscopy within 3 months. Findings of FIT testing and if positive the colonoscopy will be documented and participation in the study will end after that. Findings of the FIT test and colonoscopy will be treated according to the institutional standards. If FIT test is negative patient will leave the study and will have a follow up with a colonoscopy or FIT test in 1 to 2 years outside of this study. |
|
| undergoing CT colonography as surveillance exam | Active Comparator | If CTC is positive: patients will have subsequent colonoscopy within 3 months. Findings will be documented and participation in the study will end there. Findings of the colonoscopy will be addressed according to our institution's guidelines. If CTC is negative for polypoid lesions patient will leave the study and will have a follow up 5 years after with either a CTC or colonoscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| colonoscopy | Diagnostic Test | colonoscopy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of detection of neoplastic colon polyp | Number of patients with a neoplastic colon polyp detected during colonoscopy | 12 months |
| Comparaison of neoplastic colon polyp number detected between CTC and colonoscopy | The number of neoplastic colon polyp detected with the CTC compare to the number of neoplastic colon polyp detected with colonoscopy | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients on the list having a positive or negative FIT test or CTC and diagnosed with advanced neoplasia, non-advanced CR neoplasia, CR cancerous and precancerous lesions on colonoscopy | Number of patients on the list having a positive or negative FIT test or CTC and diagnosed with advanced neoplasia, non-advanced CR neoplasia, CR cancerous and precancerous lesions on colonoscopy | 12 months |
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Inclusion Criteria:
- people with referral sheets for surveillance colonoscopies : meaning 3 or 5 years after the initial colonoscopy.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel von Renteln | Centre hospitalier de l'Université de Montréal (CHUM) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire de Montréal | Montreal | Quebec | Canada |
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| ID | Term |
|---|---|
| D018256 | Adenomatous Polyps |
| ID | Term |
|---|---|
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D003113 | Colonoscopy |
| D023881 | Colonography, Computed Tomographic |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
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patients who meet the eligibility requirements will be randomized in a double-blind manner (participant and investigator) in a 1:1:1 ratio into 3 groups
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| FIT test |
| Diagnostic Test |
faecal immunochemical test |
|
| CT colonography | Diagnostic Test | noninvasive medical imaging technique that uses computed tomography to visualize the interior of the colon and rectum especially to screen for polyps or cancerous growths |
|
| Number of patients on the list having a CTC and diagnosed with advanced neoplasia, non-advanced CR neoplasia, CR cancerous and precancerous lesions on colonoscopy | Number of patients on the list having a CTC and diagnosed with advanced neoplasia, non-advanced CR neoplasia, CR cancerous and precancerous lesions on colonoscopy | 12 months |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D014057 | Tomography, X-Ray Computed |
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |