Comparing the ADR With Air Insufflation, Water Immersion and Water Exchange During Two-endoscopist Colonoscopy

Study Overview
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Brief Summary
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Interval (missed) cancers and lower than expected mortality reduction of proximal colon cancers in the United States and elsewhere after screening colonoscopy drew attention to quality indicators. Missed adenomas which are more likely to be in the proximal colon may be contributing factors. An independent predictor of the risk of interval cancers is adenoma detection rate. In pilot observations, the investigators showed that water exchange enhanced adenoma detection in the right colon (cecum to hepatic flexure). This prospective, randomized controlled trial will compare water exchange with water immersion and traditional air insufflation in patients undergoing colonoscopy. The investigators test the hypothesis that compared with air insufflation and water immersion, water exchange produces a significantly higher adenoma detection rate in the right colon

Detailed Description
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All of the procedures will be recorded and stored as digital files.

Official Title
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A Randomized, Controlled Trial Comparing the Adenoma Detection Rate With Air Insufflation, Water Immersion and Water Exchange During Two-endoscopist Colonoscopy

Conditions
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Adenoma

Intervention / Treatment
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* Procedure: Air insufflation
* Procedure: water immersion
* Procedure: water exchange


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing colonoscopy performed by the participating endoscopists Exclusion Criteria: obstructive lesions of the colon known before colonoscopy massive ascites past history of partial colectomy refusal to provide written informed consent

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: air insufflation<br>Air insufflation will be used throughout whole procedure of colonoscopy | Procedure: Air insufflation<br>* Insufflation during colonoscopy including insertion phase<br>|
| Active Comparator: water immersion<br>Water will be infused during the insertion phase and removed during withdrawal phase of colonoscopy | Procedure: water immersion<br>* Water will infused during insertion phase and removed during withdrawal phase of colonoscopy<br>|
| Active Comparator: water exchange<br>Water will be infused and removed during insertion phase of colonoscopy | Procedure: water exchange<br>* Water will infused and removed during insertion phase of colonoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adenoma detection rate in the right colon |  | one week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall adenoma detection rate |  | one week | 
| post-procedure discomfort | pain or distention on a 0 to 10 VAS scale | 1 day after colonoscopy | 
| 30 days complication rate | incidence of bleeding, perforation and unexpected admission | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenoma detection rate, colonoscopy, water exchange