The Impact of Distraction on Adenoma Detection Rate

Study Overview
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Brief Summary
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The investigators will review video-recordings of three randomized, controlled trials (NCT01535326, 01699399, and 01894191) comparing air insufflation, water immersion and water exchange during colonoscopy. These studies were all conducted at Buddhist Dalin Tzu Chi Hospital.

Detailed Description
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The investigators will review video-recordings of three randomized controlled trials (NCT01535326, 01699399, and 01894191) comparing air insufflation, water immersion and water exchange. These studies were conducted at Buddhist Dalin Tzu Chi Hospital. Permission will be obtained from the local Institutional Review Board (IRB) to review, analyze and report de-identified findings. Two experienced endoscopists (YHH and CWT) performed all the recorded colonoscopies. Recordings will be selected for review if they are complete examinations; include clear identification of the appendiceal orifice and/or the ileocecal valve, indicating arrival at the cecum; available in the appropriate format for video editing; and contain no patient or endoscopist identifiers. Patients with incomplete recordings and a history of bowel resection will be excluded from analysis. The included video recordings will be edited to remove the insertion phase to blind the study reviewer to the insertion techniques. One blinded reviewer uninvolved in the performance of the colonoscopies will be in charge of evaluating the selected videos, using the criteria described by Yung et al

Official Title
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The Impact of Distraction on Adenoma Detection Rate in Patients Undergoing Colonoscopy With Air Insufflation, Water Immersion and Water Exchange

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: if they are complete examinations; include clear identification of the appendiceal orifice and/or the ileocecal valve, indicating arrival at the cecum; available in the appropriate format for video editing; and contain no patient or endoscopist identifiers. Exclusion Criteria: Patients with incomplete recordings and a history of bowel resection will be excluded from analysis.

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


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>* Air 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 |  | one week after colonoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distraction score |  | Immediate after video reviewing | 
| Withdrawal technique as specified by Lee RH (citation 1) | adequacy of distention (0-5), fold examination (0-5) and cleaning (0-5) for each colonic segment | immediate after video reviewing | 
| Bowel preparation score | Boston bowel preparation score | immediate after video reviewing | 

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