Colon Cancer, Colorectal Cancer, Rectal Cancer
Conditions
Brief summary
The investigators' null hypothesis is that a withdrawal time of 9 to 10 minutes is non-inferior to a withdrawal time of 12 minutes or greater. Thus, the goal of this tandem design trial is to compare the additional diagnostic yield (# of missed lesions) for withdrawal times exceeding 10 minutes for screening/surveillance colonoscopies. Although withdrawal times longer than the standard 6-minute recommendation have been shown to be beneficial, there is limited prospective evidence investigating the benefit or lack thereof for withdrawal times greater than 9-10 minutes.
Interventions
PROCEDUREColonoscopy with 6 minute withdrawal
Withdrawal time will be determined using a digital stopwatch by the nursing staff.
PROCEDUREColonoscopy 9 minute withdrawal
Withdrawal time will be determined using a digital stopwatch by the nursing staff.
PROCEDUREColonoscopy 12 minute withdrawal
Withdrawal time will be determined using a digital stopwatch by the nursing staff.
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Must be between the ages of 18 and 75 years * Must be a patient undergoing screening or surveillance colonoscopy * Must be able to understand and willing to sign an IRB-approved written informed consent document.
Exclusion criteria
* Inability to provide informed consent. * Personal history of colorectal cancer (CRC) * Personal history of colon surgery or colon resection * Personal history of Inflammatory bowel disease * Personal history of familial polyposis * Current pregnancy * Active GI bleeding * Colonoscopy exams where the cecum cannot be reached (randomization will occur after cecum is reached).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Miss rate of polyps | Time of colonoscopy (day 1) | * Miss rate = missed polyps/missed polyps + polyps found during 1st exam * Polyps is defined as adenomas and sessile serrated adenomas (SSA) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Miss rate of advanced adenomas | Time of colonoscopy (day 1) | * Miss rate = missed advanced adenomas/missed advanced adenomas + advanced adenomas found during 1st exam * Advanced adenoma defined as a polyp ≥ 10mm, adenomas with high-grade dysplasia or villous architecture, serrated lesions with dysplasia, or traditional serrated adenomas |
Countries
United States
Outcome results
None listed