A Comparison of Methods to Detect Polyps During Colonoscopy

Colorectal Cancer Clinical Trial

Official title:

Comparison of Detection of Polyps During Both Insertion and Withdrawal Phases of Colonoscopy Versus the Standard Practice of Detection of Polyps During the Withdrawal Phase of Colonoscopy: A Prospective Quality Improvement Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01025960
• Other study ID #: 09-786
• Status: Completed
• Phase: N/A
• First received: December 2, 2009
• Last updated: March 26, 2012
• Start date: November 2009
• Est. completion date: January 2012

Study information

• Verified date: March 2012
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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to the approach whereby the physician examines the bowel as the scope is initially inserted AND as the colonoscope is withdrawn from patients' colons.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 768
• Est. completion date: January 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colorectal Cancer

Intervention

Procedure:
• Standard Inspection Colonoscopy
The large bowel will be inspected for polyps during the withdrawal of the colonoscope to the cecum, and during the withdrawal of the scope from the large bowel.
• 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.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adenoma detection rates for each method		within the first 30 days after colonoscopy	No
Secondary	Comparison of procedure times for each method		1 year	No
Secondary	Percentage of patients with at least one adenoma detected by each method		1 year	No
Secondary	Comparison of percentage of adenomas classified as high risk for each method		1 year	No