Unsedated Colonoscopy for Colorectal Cancer Screening and Surveillance

Study Overview
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Brief Summary
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In a prospective, randomized, controlled study, two methods (water method vs. air method) of performing colonoscopy will be compared in patients undergoing unsedated colonoscopy for CRC screening. The investigators hypothesize that: Study method increases overall cecal intubation with comparable assessment of current experience and patient willingness to repeat future colonoscopy compared with conventional colonoscopy Study method improves bowel preparation and increases polyp pickup rate

Detailed Description
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Colorectal cancer (CRC) screening for the high and the low risk healthy asymptomatic Veterans Affairs (VA) patients is being promoted. Compliance with this Directive will result in an increased number of VA patients undergoing colonoscopy. The demand for colonoscopy far exceeds the capacity available to perform the procedure in the VA system. The conventional practice for colonoscopy at VA facilities across the country is to perform colonoscopy under conscious sedation with air insufflation. Efficiency is governed by the fact that sedated patients require time and space for recovery and these are major limiting factors in the current setting for the use of colonoscopy for CRC screening. In a prospective, randomized, controlled trial (RCT), two methods of performing colonoscopy will be compared in patients undergoing unsedated colonoscopy for CRC screening. We compared the water infusion in lieu of air insufflation (water method) with the conventional air insufflation method. We hypothesize that the water method (Study method) increases overall cecal intubation with comparable assessment of current experience and patient willingness to repeat future colonoscopy compared with conventional colonoscopy. In addition, the water method improves bowel preparation and increases polyp pickup rate.

Official Title
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Comparison of Study Method Versus Conventional Method for Performing Unsedated Colonoscopy for Colorectal Cancer Screening and Surveillance

Conditions
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Colon Polyp

Intervention / Treatment
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* Procedure: Water infusion in lieu of air insufflation
* Procedure: Air method


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult (>50 years old) Male and female patients Scheduled and consented for screening or surveillance colonoscopy without medications Accept randomization to the study or the conventional method Agree to complete study questionnaires The adults will be normal healthy patients or patients with mild systemic disease, ASA 1 or ASA 2. Exclusion Criteria: Patients who decline to participate Unable to give informed consent or complete the questionnaires due to language or other difficulties

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 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: Screening
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Water method<br>Water infusion in lieu of air insufflation for screening and surveillance colonoscopy | Procedure: Water infusion in lieu of air insufflation<br>* Air pump is turned off, water is infused using a peristaltic pump to aid colonoscope insertion until the cecum is reached. Air pockets and dirty water are suctioned before clean water is infused (exchange) to facilitate scope insertion.<br>* Other names: Screening colonoscopy;|
| Active Comparator: Air method<br>Air insufflation for screening and surveillance colonoscopy | Procedure: Air method<br>* Conventional air method with minimal insufflation of air to aid scope insertion until the cecum is reached. Water in aliquots will be used for irrigation and cleansing.<br>* Other names: Screening colonoscopy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success of colonoscopy | successful cecal intubation | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polyp detection | Adenoma detection rate | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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water method, air method, unsedated colonoscopy, adenoma detection