This clinical trial evaluates the effect of withdrawal time on cancer detection rates in patients undergoing standard of care screening colonoscopies. A colonoscopy is a standard medical procedure to screen for colorectal cancer using a long, thin and flexible tube-like instrument with a light and lens or small video camera on the end for viewing. Colorectal cancer develops from either an adenoma or a serrated sessile lesion. Removal of these lesions have been shown to decrease risk of colorectal cancer. Colonoscopy withdrawal time, the time it takes for an endoscopy to remove the colonoscopy from the cecum to anus, is an important quality indicator. Current guidelines recommend a withdrawal time of at least 6 minutes to decrease risk of missed polyps, which in turn increases the risk of developing colorectal cancer. This study may help improve colonoscopy quality standards.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05018325.
PRIMARY OBJECTIVE:
I. To complete a 3-arm tandem colonoscopy study to compare the standard colonoscopy withdrawal time of 6 mins with longer withdrawal times of 9 minutes and 12 minutes to determine the polyp (adenoma and SSA) miss rate.
SECONDARY OBJECTIVE:
I. To determine the miss rate of advanced adenomas between study groups.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM A: Patients undergo standard of care colonoscopy with standard 6-minute withdrawal time, and then a tandem colonoscopy with at least another 6-minute withdrawal time.
ARM B: Patients undergo standard of care colonoscopy with a 9-minute withdrawal time, and then a tandem colonoscopy with at least another 6-minute withdrawal time.
ARM C: Patients undergo standard of care colonoscopy with a 12-minute withdrawal time, and then a tandem colonoscopy with at least another 6-minute withdrawal time.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationSiteman Cancer Center at Washington University
Principal InvestigatorVladimir Kushnir
