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

Not Applicable

Completed

• Conditions: Colonoscopy
• Interventions: Device: Conventional Pediatric Colonoscope; Device: Short-Turn Radius Colonoscope

• Registration Number: NCT03807089
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-01
• Primary Completion: 2017-05-11
• Study Completion: 2017-05-11
• Study First Submitted: 2019-01-11
• Study First Submitted QC: 2019-01-14
• Study First Posted: 2019-01-16
• Results First Submitted: 2019-05-29
• Status Verified: 2019-06
• Results First Submitted QC: 2019-06-27
• Last Update Submitted: 2019-06-27
• Results First Posted: 2019-07-16
• Last Update Posted: 2019-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 283

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Pediatric Colonoscope	Conventional Pediatric Colonoscope	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 The colonoscope will then be re-advanced to the cecum and again withdrawn using the forward-facing view.
Short-Turn Radius Colonoscope	Short-Turn Radius Colonoscope	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With At Least One Adenoma	1 hour	Compare adenoma detection rate between patients undergoing a colonoscopy with Pentax Retroview colonoscope and pediatric colonoscope.

Secondary Outcome Measures

Name	Time	Method
Mean Number of Adenomas Identified Per Patient With Polyps	1 hour	Compare average number of adenomas found per patient with polyps between patients undergoing a colonoscopy with Pentax Retroview colonoscope and pediatric colonoscope.
Overall Polyp Detection Rate	1 hour	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.