Comparison of Adenoma Detection Rate Among Water, Carbon Dioxide and Air Methods of Minimal Sedation Colonoscopy

Study Overview
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Brief Summary
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The purpose of this study is to determine which of the methods of colonoscopy viz. water insufflation or air insufflation or carbon dioxide insufflation is better in detecting the adenomas in colon and also which of these methods is best tolerated by patients. Hypothesis: the investigators hypothesize that in patients undergoing first time screening colonoscopy a higher Adenoma Detection Rate will be found in the proximal colon in the group randomized to the water method compared to those randomized to the air or CO2 insufflation methods

Detailed Description
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Significance: ADR is an independent predictor of risk of post screening colonoscopy colon cancer. A simple method solely controlled by the colonoscopist that enhances proximal ADR holds the promise of rectifying some of the unresolved shortcomings of screening colonoscopy in failing to reduce the occurrence of post screening incident cancers in the proximal colon and the associated cancer mortality. Hypotheses & Specific Aims: Primary Hypothesis: In patients undergoing first time screening a higher ADR will be found in the proximal colon in those randomized to the water method compared to those randomized to the air method or CO2 method. Secondary Hypotheses: The examination method but not co-variables, procedure-related or patient-centered outcomes, is an independent predictor of proximal colon ADR. Specific Aims: This is a prospective, randomized, single-blinded controlled study to compare the study (water) and control 1 (air) method and control 2 (CO2 method) to aid insertion of the colonoscope. The proximal colon ADR, total ADR, co-variables, procedure-related and patient-centered outcomes and adverse event during and within 30 days of colonoscopy will be recorded and compared between the study and control methods.

Official Title
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Water Infusion and Carbon Dioxide Insufflation Versus Air Insufflation Versus Air Insufflation Techniques in Screening Colonoscopies in the United States: A Comparative Study Evaluating Safety, Efficacy and Adenoma Detection Rate (ADR)

Conditions
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Screening Colonoscopy

Intervention / Treatment
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* Procedure: colonoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Asymptomatic patients with average risk for colorectal cancer, who are scheduled for first-time screening colonoscopy, will be enrolled. Exclusion Criteria: decline to be randomized unable to give consent non-screening (surveillance or diagnostic) colonoscopy current participation in other colonoscopy studies a medical condition that could increase the risk associated with colonoscopy pregnancy those with a known family history of polyposis syndromes or a family history of colon cancer

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: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Water Insufflation<br>Colonoscopy using water insufflation | Procedure: colonoscopy<br>* colonoscopy using different methods of insufflation<br>|
| Active Comparator: Carbon dioxide insufflation<br>Colonoscopy using carbon dioxide insufflation | Procedure: colonoscopy<br>* colonoscopy using different methods of insufflation<br>|
| Active Comparator: Air insufflation<br>Colonoscopy using air insufflation | Procedure: colonoscopy<br>* colonoscopy using different methods of insufflation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma Detection Rate, proximal colon and total | The number of adenomas detected in proximal colon and total number of adenomas detected during the procedure will be compared between the three methods | Day 1, At time of colonoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores | Visual Analog Scales will be used to calculate the pain scores based on the discomfort/pain experienced by the patient | during and immediately after colonoscopy on day 1 | 
| Sedation requirements | The amount of sedation required to complete the patient's colonoscopy. | Collected at Day 1, during the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Screening colonoscopy, Water method, Carbon dioxide method, Air method, Water versus carbon dioxide versus air insufflation colonoscopy, Adenoma Detection Rate, Pain Scores in colonoscopy