Right Sided Colon Polyp Miss Rate: Impact Of Retroflexion In The Right Colon

Not Applicable

• Conditions: Colon Polyps; Colon Cancer Screening
• Interventions: Procedure: Retroflexion in the right colon

• Registration Number: NCT01704820
• Lead Sponsor: Washington University School of Medicine

Brief Summary

Colonoscopy is the gold standard screening test for colorectal cancer. Removal of pre-malignant colon polyps during colonoscopy reduces colorectal cancer mortality by over 50%. However, while colonoscopy is highly effective at preventing distal (left sided) colon cancers, it provides only limited protection from cancer in the proximal (right side) colon. Our goal is to determine if additional pre-cancerous colon polyps can be identified by looking at the right side of the colon in retroflexion. During retroflexion the tip of the colonoscope is turned 180 degrees; allowing the doctor to view the backs of colonic folds. If additional polyps can be identified in this manner colonoscopy will become a more efficient method of screening for colon cancer.

In order to evaluate how effective right colon retroflexion is at detecting polyps in the proximal colon we plan on performing a randomized, controlled trial. Patients undergoing screening or follow up colonoscopy will be invited to participate in the study. Those patients who agree to participate will be randomized into one of two groups once the colonoscope is fully inserted. Group one will have the right side of their colon examined for polyps with the endoscope looking forward (traditional form of examination) followed by repeat examination of the right side of the colon with the colonosocpe in retroflexion (looking backwards). Polyps seen during each section of the exam will be removed and manner in which the polyps were found/ removed will be recorded. Following the two exams of the right side of the colon the colonoscopy will be completed in the usual manner. The duration of each portion of colonoscopy will be recorded. After the procedure is completed the physician performing the colonoscopy will rate difficulty of the procedure and confidence with quality of the examination. Pathology results for each polyp will be recorded once available. There will be no study related follow up after the pathology results are recorded.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-10-08
• Study First Submitted QC: 2012-10-10
• Study First Posted: 2012-10-11
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-29
• Last Update Posted: 2013-05-31
• Primary Completion: 2014-09
• Study Completion: 2014-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1020

Inclusion Criteria

• • Patients >18 years of age undergoing colonoscopy for colorectal cancer screening or routine polyp surveillance

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Exclusion Criteria

• • Failure to intubate the cecum during colonoscope insertion

  • Prior right colon resection
  • Known polyposis syndrome or polyposis identified at colonoscopy
  • Inflammatory bowel disease
  • Preparation of the colon is judged fair or poor using Boston Bowel Preparation Scale.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Retroflexion arm	Retroflexion in the right colon	Retroflexion arm: retroflexion in the cecum or proximal ascending colon and slow withdrawal to the hepatic flexure with removal of all visible colon polyps

Primary Outcome Measures

Name	Time	Method
Per patient adenoma detection rate (average # adenomas detected/ patient in each arm of the study).	2 weeks	The primary objective of our study is to determine whether the diagnostic yield for pre-malignant polyps is increased by retroflexion of the colonoscope during withdrawal from the proximal colon when compared to the diagnostic yield of a second examination of the proximal colon with the colonoscope in forward view.

Secondary Outcome Measures

Name	Time	Method
Evaluate the success rate of retroflexion in the proximal colon.	1 day	Evaluate the percent of patients in whom retroflexion can be performed.
Identify risk factors for missing polyps on first examination of right colon	1 day	We will perform a multivariable analysis in order to identify patient and procedure related factors which are associated with missed polyps.
Access whether duration of exam is different in the retroflexion vs. forward view arms of the study.	1 day	Access whether duration of exam is different in the retroflexion vs. forward view arms of the study. By timing all portions of the exam.
Evaluate endoscopist comfort with performing retroflexion in the proximal colon.	1 day	Evaluate endoscopist comfort with performing retroflexion in the proximal colon using a 5 point Likert scale

Trial Locations

Locations (2)

Washington University in St Louis; 🇺🇸 St Louis, Missouri, United States

Medical College of Wisconsin; 🇺🇸 Milwaukie, Wisconsin, United States