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OpenTrials
Completed

NCT Number: NCT01025960

A Comparison of Methods to Detect Polyps During Colonoscopy

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to the approach whereby the physician examines the bowel as the scope is initially inserted AND as the colonoscope is withdrawn from patients' colons.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps Rectal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard Inspection Colonoscopy

Procedure

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

Procedure

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 outcomes

  1. Adenoma detection rates for each method

    Time frame: within the first 30 days after colonoscopy

Secondary outcomes

  1. Comparison of procedure times for each method

    Time frame: 1 year

  2. Percentage of patients with at least one adenoma detected by each method

    Time frame: 1 year

  3. Comparison of percentage of adenomas classified as high risk for each method

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Dec 4, 2009
Registry last updated
Mar 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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