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
1 other identifier
interventional
768
1 country
1
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to the approach whereby the physician examines the bowel as the scope is initially inserted AND as the colonoscope is withdrawn from patients' colons.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable colorectal-cancer
Started Nov 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 2, 2009
CompletedFirst Posted
Study publicly available on registry
December 4, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedMarch 27, 2012
March 1, 2012
2.1 years
December 2, 2009
March 26, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adenoma detection rates for each method
within the first 30 days after colonoscopy
Secondary Outcomes (3)
Comparison of procedure times for each method
1 year
Percentage of patients with at least one adenoma detected by each method
1 year
Comparison of percentage of adenomas classified as high risk for each method
1 year
Study Arms (2)
Standard Inspection Colonoscopy
OTHERThe colonoscope will be inserted rapidly to reach the cecum. Inspection of the large bowel will occur during the withdrawal of the colonoscope.
Dual Inspection Colonoscopy
ACTIVE COMPARATORThe 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.
Interventions
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.
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 Criteria
You may qualify if:
- Adult patients
- Patients able to provide an informed consent
- Patients undergoing colonoscopy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Related Publications (1)
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.
PMID: 25037727DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Madhusudhan Sanaka, MD
The Cleveland Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2009
First Posted
December 4, 2009
Study Start
November 1, 2009
Primary Completion
December 1, 2011
Study Completion
January 1, 2012
Last Updated
March 27, 2012
Record last verified: 2012-03