Assessing Effect of Withdrawal Time on Adenoma Detection Rate for Screening Colonoscopy

Study Overview
=================
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.

Official Title
-----------------
Assessing Effect of Withdrawal Time on Adenoma Detection Rate for Screening Colonoscopy: A Randomized Tandem Study

Conditions
-----------------
Colon Cancer, Rectal Cancer, Colorectal Cancer

Intervention / Treatment
-----------------
* Procedure: Colonoscopy with 6 minute withdrawal
* Procedure: Colonoscopy 9 minute withdrawal
* Procedure: Colonoscopy 12 minute withdrawal


Participation Criteria
=================
Eligibility Criteria
-----------------
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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1: Colonoscopy 6 minute withdrawal time<br>-Undergo colonoscopy with the standard 6-minute withdrawal time followed by a tandem colonoscopy of at least another 6-minute withdrawal time. | Procedure: Colonoscopy with 6 minute withdrawal<br>* Withdrawal time will be determined using a digital stopwatch by the nursing staff.<br>|
| Experimental: Arm 2: Colonoscopy 9 minute withdrawal time<br>-Undergo a 9-minute withdrawal time followed by a tandem colonoscopy with at least the standard 6-minute withdrawal time. | Procedure: Colonoscopy 9 minute withdrawal<br>* Withdrawal time will be determined using a digital stopwatch by the nursing staff.<br>|
| Experimental: Arm 3: Colonoscopy 12 minute withdrawal time<br>-Undergo colonoscopy with a 12-minute withdrawal time followed by a tandem colonoscopy with at least the standard 6-minute withdrawal time | Procedure: Colonoscopy 12 minute withdrawal<br>* Withdrawal time will be determined using a digital stopwatch by the nursing staff.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Miss rate of polyps | Miss rate = missed polyps/missed polyps + polyps found during 1st exam Polyps is defined as adenomas and sessile serrated adenomas (SSA) | Time of colonoscopy (day 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Miss rate of advanced adenomas | 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 | Time of colonoscopy (day 1) |