RCT of Air Insufflation Versus Water Infusion Colonoscopy by Supervised Trainees

Study Overview
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Brief Summary
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Our aim is to perform a randomized-controlled trial comparing air insufflation sedated colonoscopy (conventional method) vs. water infusion sedated colonoscopy (study method) by supervised trainees. Randomized trials demonstrating reduced need for sedation medications without compromising patients' comfort, cecal intubation rates or polyps detection may cause a paradigm shift and positively alter the way traditional colonoscopy is performed and future endoscopists are trained.

Detailed Description
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Background: A novel water method permitted 52% of patients accepting on-demand sedation to complete colonoscopy without medications and significantly increased successful cecal intubation from 76% to 97% in patients accepting scheduled unsedated colonoscopy. Aim: To perform a randomized controlled trial comparing air insufflation (conventional method) vs. water infusion in lieu of air (study method) colonoscopy in minimally sedated patients by supervised trainees. Hypothesis: Compared with the conventional method, patients examined by the study method have lower pain scores and require less medication but have similar cecal intubation rate and willingness to repeat future colonoscopy. Setting: Outpatient colonoscopy in a single VA hospital Methods: After informed consent and standard bowel preparation, patients received pre-medications administered as 0.5 increment of Fentanyl (25 μg) and 0.5 increment of Versed (1 mg) plus 50 mg Diphenhydramine. The conventional and the study method for colonoscopy were implemented as previously described. Additional pain medications were administered at the patients' request. Outcome measures: Increments of medications, pain scores, cecal intubation and willingness to repeat colonoscopy. Limitations: Single VA site, older male population

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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Procedure: Colonoscopy for colorectal cancer screening
* Procedure: Water Infusion Colonoscopy
* Procedure: Air insufflation colonoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Adult (> 50 years old) male and female patients who are scheduled and consented for screening or surveillance colonoscopy, Accept randomization to the study or the conventional method, and 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 have contraindications for sedation, decline to participate, unable to give informed consent or complete the questionnaires due to language or other difficulties will be excluded Excluded patients will be managed by usual procedures

Ages Eligible for Study
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Minimum Age: 50 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: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Water Infusion in lieu of Air Insufflation Colonoscopy | Procedure: Colonoscopy for colorectal cancer screening<br> <br> Procedure: Water Infusion Colonoscopy<br>* water infusion in lieu of air insufflation for screening colonoscopy<br>|
| Placebo Comparator: 2<br>Air Insufflation Colonoscopy | Procedure: Colonoscopy for colorectal cancer screening<br> <br> Procedure: Air insufflation colonoscopy<br>* Conventional colonoscopy with air insufflation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increments of medications used for sedation |  | duration of procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain score during colonoscopy |  | duration of procedure | 
| success of cecal intubation |  | duration of study | 
| willingness to repeat colonoscopy |  | duration of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal cancer screening, Optical colonoscopy, Water method, Sedation