A Comparison of Methods to Detect Polyps During Colonoscopy

• ClinicalTrials.gov Identifier: NCT01025960
• Recruitment Status: Completed
• First Posted: December 4, 2009
• Last Update Posted: March 27, 2012
• Sponsor: The Cleveland Clinic
• Information provided by (Responsible Party): The Cleveland Clinic

Study Description

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to the approach whereby the physician examines the bowel as the scope is initially inserted AND as the colonoscope is withdrawn from patients' colons.

Condition or disease	Intervention/treatment	Phase
Colorectal Cancer	Procedure: Standard Inspection Colonoscopy; Procedure: Dual Inspection Colonoscopy	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 768 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: November 2009
• Actual Primary Completion Date: December 2011
• Actual Study Completion Date: January 2012

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. Adenoma detection rates for each method [ Time Frame: within the first 30 days after colonoscopy ]

Secondary Outcome Measures :

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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Sanaka MR, Parsi MA, Burke CA, Barnes D, Church J, Rizk M, Zein N, Joseph R, Thota PN, Lopez R, Kiran RP. Adenoma detection at colonoscopy by polypectomy in withdrawal only versus both insertion and withdrawal: a randomized controlled trial. Surg Endosc. 2015 Mar;29(3):692-9. doi: 10.1007/s00464-014-3723-3. Epub 2014 Jul 19.

• Responsible Party: The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT01025960
• Other Study ID Numbers: 09-786
• First Posted: December 4, 2009
• Last Update Posted: March 27, 2012
• Last Verified: March 2012

Keywords provided by The Cleveland Clinic:

colonoscopy; adenoma detection; polyps

Additional relevant MeSH terms:

Polyps; Pathological Conditions, Anatomical