Adenoma Detection Rate With a New Pediatric Colonoscope With a Short Turn Radius (Pentax Retroview) Compared With a Standard Pentax Pediatric Colonoscope

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the new colonoscope that provides both a traditional and a retrograde view (bending 180 degrees to look behind itself) of the colon can detect more polyps than a standard colonoscope that only provides a forward-facing view. The investigators wish to effectively demonstrate the utility of the new colonoscope (Pentax Retroview Colonoscope) as the objective of this study is to determine polyp and adenoma detection rates in human subjects undergoing colonoscopy for polyp surveillance.

Official Title
-----------------
Adenoma Detection Rate With a New Pediatric Colonoscope With a Short Turn Radius (Pentax Retroview) Compared With a Standard Pentax Pediatric Colonoscope

Conditions
-----------------
Colonoscopy

Intervention / Treatment
-----------------
* Device: Conventional Pediatric Colonoscope
* Device: Short-Turn Radius Colonoscope


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability to provide Informed Consent Age > 40 Surveillance Colonoscopy (History of Adenomas) Exclusion Criteria: Poor or Fair Bowel Prep Difficult First Insertion Familial Polyposis Inflammatory Bowel Disease Pregnancy Active GI Bleeding Prior colonic or rectal resection Conserved Sattus Colonoscopy less than 3 years ago Screening Colonoscopy Colonoscopy done to evaluate systems like abdominal pain, diarrhea, constipation, change in bowel habits

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Short-Turn Radius Colonoscope<br>Colonoscopy performed with Short-Turn Radius Colonoscope. The colonoscope will provide a forward-facing view of the colon during advancement to the cecum (standard of care). The scope will then be withdrawn all the way to the rectum and the colon will be inspected using the forward-facing view (standard of care). The colonoscope will then be re-advanced to the cecum and be withdrawn using the retrograde view. | Device: Short-Turn Radius Colonoscope<br> <br> * Other names: Pentax Model EC-3490TLi;|
| Active Comparator: Conventional Pediatric Colonoscope<br>Colonoscopy will be performed with a conventional pediatric colonoscope. During withdrawal, the colon will be inspected using the forward-facing view (standard of care). The colonoscope will then be re-advanced to the cecum and again withdrawn using the forward-facing view. | Device: Conventional Pediatric Colonoscope<br> <br> * Other names: Pentax Model EG-2490K;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients With At Least One Adenoma | Compare adenoma detection rate between patients undergoing a colonoscopy with Pentax Retroview colonoscope and pediatric colonoscope. | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Polyp Detection Rate | Compare polyp detection rate (percent of patients with at least one polyp detected) between patients undergoing a colonoscopy with Pentax Retroview colonoscope and pediatric colonoscope. | 1 hour | 
| Mean Number of Adenomas Identified Per Patient With Polyps | Compare average number of adenomas found per patient with polyps between patients undergoing a colonoscopy with Pentax Retroview colonoscope and pediatric colonoscope. | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colonoscopy, colon cancer screening