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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
History of Changes
  Purpose

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to the approach whereby the physician examines the bowel as the scope is initially inserted AND as the colonoscope is withdrawn from patients' colons.


Condition Intervention
Colorectal Cancer
 Procedure: Standard Inspection Colonoscopy
Procedure: Dual Inspection Colonoscopy

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Adenoma detection rates for each method [ Time Frame: within the first 30 days after colonoscopy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 768
Study Start Date: November 2009
Study Completion Date: January 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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.
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.
 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01025960

Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Madhusudhan Sanaka, MD The Cleveland Clinic
  More Information

No publications provided

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01025960     History of Changes
Other Study ID Numbers: 09-786
Study First Received: December 2, 2009
Last Updated: March 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
colonoscopy
adenoma detection
polyps

Additional relevant MeSH terms:
Colorectal Neoplasms
Polyps
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 23, 2013