The Utility of Timed Segmental Withdrawal During Screening Colonoscopy

Study Overview
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Brief Summary
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The purpose of colonoscopy (colon examination with flexible tube and a camera) is to find early precancerous growth in the colon (polyps) and remove them before they turn into cancer. The doctor performing the procedure will first advance the colonoscope to the end of the colon (cecum) and then he will examine the colon for polyps while he is withdrawing the colonoscope. The period of time that the doctor spent examining the colon called withdrawal time. Usually doctors will spend at least 6 minutes examining the colon after he reached the cecum. The investigators are proposing that dedicating half of the withdrawal time during colonoscopy in examining the right side of the colon, will increase the detection of polyps in the right side of the colon.

Detailed Description
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Research design: This is a prospective, randomized trial comparing the ADR between patients undergoing a screening colonoscopy in four different groups: 1) at least 3 minutes from the total withdrawal time dedicated to the right side of the colon, 2) at least 4 minutes from the total withdrawal time dedicated to the right side of the colon, 3) 6 minutes total withdrawal time regardless of time spent in any segment, 4) 8 minutes total withdrawal time regardless of the time spent in any segment. Randomization will be done in blocks after stratification. Four gastroenterologists and two fellows matched base on similar ADR and stratified on each arm of the study (segmental versus non-segmental withdrawal) will be performing the procedures. The estimated sample size of the four arms of the study is 400 patients.

Official Title
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The Utility of Timed Segmental Withdrawal During Screening Colonoscopy for Increasing Adenoma Detection Rate. A Randomized Controlled Clinical Trial

Conditions
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Colonoscopy

Intervention / Treatment
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* Procedure: colonoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adults undergoing colonoscopy for screening or surveillance purposes Exclusion Criteria: prior history of colonic surgeries Crohn's colitis or ulcerative colitis prior history of colon cancer poor bowel preparation pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3 minutes in the right side colon<br>Colonoscopy, at least 3 minutes in the right side colon from the total withdrawal time | Procedure: colonoscopy<br>* colonoscopy (colon examination with flexible tube and a camera) is to find early precancerous growth in the colon (polyps) and remove them before they turn into cancer<br>|
| Experimental: 4 minutes in the right side colon<br>Colonoscopy, at least 4 minutes in the right side colon from the total withdrawal time | Procedure: colonoscopy<br>* colonoscopy (colon examination with flexible tube and a camera) is to find early precancerous growth in the colon (polyps) and remove them before they turn into cancer<br>|
| No Intervention: 6 minutes whole withdrawal time<br>Colonoscopy, at least 6 minutes whole withdrawal time regardless of time spent in any segment | |
| Experimental: 8 minutes whole withdrawal time<br>Colonoscopy, at least 8 minutes whole withdrawal time regardless of time spent in any segment | Procedure: colonoscopy<br>* colonoscopy (colon examination with flexible tube and a camera) is to find early precancerous growth in the colon (polyps) and remove them before they turn into cancer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polyp detection rate (PDR) and Adenoma detection rate (ADR) of patients undergoing a screening colonoscopy either with segmental withdrawal protocol or with non-segmental withdrawal protocol. | Compare polyp detection rate (PDR) and ADR between patients undergoing a screening colonoscopy with segmental withdrawal protocol and with non-segmental withdrawal protocol. | 30 minutes | 
| The Polyp detection rate( PDR) and Adenoma detection rate (ADR) of patients undergoing screening colonoscopy either with 6-minutes or 8-minutes protocols of the segmental withdrawal. | Compare PDR and ADR between patients undergoing a screening colonoscopy with at least 6-minutes protocol versus at least 8-minutes protocol within each segmental and non-segmental withdrawal protocol. | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The polyp detection rate( PDR) and Adenoma detection rate (ADR) of patients undergoing screening colonoscopy either with 3-minutes or 4-minutes protocols of the non segmental withdrawal | 1. Compare PDR and ADR associated with different withdrawal times with segmental and non segmental withdrawal protocol. Compare sessile serrated lesion detection rate between patients undergoing a screening colonoscopy with segmental and non segmental withdrawal protocol. | 30 minutes | 
| Complication rate | The complication rate of patients undergoing a screening colonoscopy with segmental and non segmental withdrawal protocol will be reported | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Screening colonoscopy, Surveillance colonoscopy