A Comparison of Methods to Detect Polyps During Colonoscopy

Not Applicable

Completed

• Conditions: Colorectal Cancer
• Interventions: Procedure: Standard Inspection Colonoscopy; Procedure: Dual Inspection Colonoscopy

• Registration Number: NCT01025960
• Lead Sponsor: The Cleveland Clinic

Brief Summary

Colorectal cancer (CRC) is the third most common cancer and second leading cause of cancer deaths in western countries. Colonoscopy is a preferred colorectal screening modality since it has both diagnostic and therapeutic capability. Detection and removal of polyps at colonoscopy decreases the incidence and mortality from colorectal cancer.

Typical practice is to insert the colonoscope rapidly until it reaches the cecum (a pouch-like portion of the intestines, where the large bowel and the small bowel meet). The physician then withdraws the colonoscope slowly and looks for any polyps or abnormalities within the large bowel. The purpose of this study is to compare this standard practice to the approach whereby the physician examines the bowel as the scope is initially inserted AND as the colonoscope is withdrawn from patients' colons.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-12-02
• Study First Submitted QC: 2009-12-02
• Study First Posted: 2009-12-04
• Primary Completion: 2011-12
• Study Completion: 2012-01
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-26
• Last Update Posted: 2012-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 768

Inclusion Criteria

• Adult patients
• Patients able to provide an informed consent
• Patients undergoing colonoscopy

Exclusion Criteria

• Pregnant women
• Patients with Familial Adenomatous Polyposis Syndromes (FAP)
• Patients with Hereditary Non-polyposis Colon Cancer Syndrome (HNPCC)
• Patients who have undergone previous surgical resection of the colon
• Patients who have been diagnosed with inflammatory bowel disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Inspection Colonoscopy	Standard Inspection Colonoscopy	The colonoscope will be inserted rapidly to reach the cecum. Inspection of the large bowel will occur during the withdrawal of the colonoscope.
Dual Inspection Colonoscopy	Dual Inspection Colonoscopy	The large bowel will be inspected for polyps during the insertion of the colonoscope to the cecum, and during the withdrawal of the scope from the large bowel.

Primary Outcome Measures

Name	Time	Method
Adenoma detection rates for each method	within the first 30 days after colonoscopy

Secondary Outcome Measures

Name	Time	Method
Comparison of procedure times for each method	1 year
Percentage of patients with at least one adenoma detected by each method	1 year
Comparison of percentage of adenomas classified as high risk for each method	1 year

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States