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A Comparison of Methods to Detect Polyps During Colonoscopy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01025960
First received: December 2, 2009
Last updated: March 26, 2012
Last verified: March 2012

December 2, 2009
March 26, 2012
November 2009
December 2011   (final data collection date for primary outcome measure)
Adenoma detection rates for each method [ Time Frame: within the first 30 days after colonoscopy ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01025960 on ClinicalTrials.gov Archive Site
  • Comparison of procedure times for each method [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Percentage of patients with at least one adenoma detected by each method [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Comparison of percentage of adenomas classified as high risk for each method [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Comparison of Methods to Detect Polyps During Colonoscopy
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

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to the approach whereby the physician examines the bowel as the scope is initially inserted AND as the colonoscope is withdrawn from patients' colons.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Colorectal Cancer
  • 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.
  • Procedure: 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.
  • 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.
    Intervention: Procedure: Standard Inspection Colonoscopy
  • Active Comparator: 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.
    Intervention: Procedure: Dual Inspection Colonoscopy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
768
January 2012
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01025960
09-786
Yes
The Cleveland Clinic
The Cleveland Clinic
Not Provided
Principal Investigator: Madhusudhan Sanaka, MD The Cleveland Clinic
The Cleveland Clinic
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP