A Comparison of Methods to Detect Polyps During Colonoscopy

Study Overview
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Brief Summary
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Colorectal cancer (CRC) is the third most common cancer and second leading cause of cancer deaths in western countries. Colonoscopy is a preferred colorectal screening modality since it has both diagnostic and therapeutic capability. Detection and removal of polyps at colonoscopy decreases the incidence and mortality from colorectal cancer. Typical practice is to insert the colonoscope rapidly until it reaches the cecum (a pouch-like portion of the intestines, where the large bowel and the small bowel meet). The physician then withdraws the colonoscope slowly and looks for any polyps or abnormalities within the large bowel. The purpose of this study is to compare this standard practice to the approach whereby the physician examines the bowel as the scope is initially inserted AND as the colonoscope is withdrawn from patients' colons.

Official Title
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Comparison of Detection of Polyps During Both Insertion and Withdrawal Phases of Colonoscopy Versus the Standard Practice of Detection of Polyps During the Withdrawal Phase of Colonoscopy: A Prospective Quality Improvement Study

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Procedure: Standard Inspection Colonoscopy
* Procedure: Dual Inspection Colonoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients Patients able to provide an informed consent Patients undergoing colonoscopy Exclusion Criteria: Pregnant women Patients with Familial Adenomatous Polyposis Syndromes (FAP) Patients with Hereditary Non-polyposis Colon Cancer Syndrome (HNPCC) Patients who have undergone previous surgical resection of the colon Patients who have been diagnosed with inflammatory bowel disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Standard Inspection Colonoscopy<br>The colonoscope will be inserted rapidly to reach the cecum. Inspection of the large bowel will occur during the withdrawal of the colonoscope. | Procedure: Standard Inspection Colonoscopy<br>* The large bowel will be inspected for polyps during the withdrawal of the colonoscope to the cecum, and during the withdrawal of the scope from the large bowel.<br>|
| Active Comparator: Dual Inspection Colonoscopy<br>The large bowel will be inspected for polyps during the insertion of the colonoscope to the cecum, and during the withdrawal of the scope from the large bowel. | Procedure: Dual Inspection Colonoscopy<br>* The large bowel will be inspected for polyps during the insertion of the colonoscope to the cecum, and during the withdrawal of the scope from the large bowel.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma detection rates for each method |  | within the first 30 days after colonoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of procedure times for each method |  | 1 year | 
| Percentage of patients with at least one adenoma detected by each method |  | 1 year | 
| Comparison of percentage of adenomas classified as high risk for each method |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colonoscopy, adenoma detection, polyps