The Utility of Timed Segmental Withdrawal During Screening Colonoscopy

Overview

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.

Full Title of Study: “The Utility of Timed Segmental Withdrawal During Screening Colonoscopy for Increasing Adenoma Detection Rate. A Randomized Controlled Clinical Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Screening
    • Masking: Single (Participant)
  • Study Primary Completion Date: December 2015

Detailed Description

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.

Interventions

  • Procedure: colonoscopy
    • 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

Arms, Groups and Cohorts

  • Experimental: 3 minutes in the right side colon
    • Colonoscopy, at least 3 minutes in the right side colon from the total withdrawal time
  • Experimental: 4 minutes in the right side colon
    • Colonoscopy, at least 4 minutes in the right side colon from the total withdrawal time
  • No Intervention: 6 minutes whole withdrawal time
    • Colonoscopy, at least 6 minutes whole withdrawal time regardless of time spent in any segment
  • Experimental: 8 minutes whole withdrawal time
    • Colonoscopy, at least 8 minutes whole withdrawal time regardless of time spent in any segment

Clinical Trial Outcome Measures

Primary Measures

  • 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.
    • Time Frame: 30 minutes
    • Compare polyp detection rate (PDR) and ADR between patients undergoing a screening colonoscopy with segmental withdrawal protocol and with non-segmental withdrawal protocol.
  • 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.
    • Time Frame: 30 minutes
    • 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.

Secondary Measures

  • 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
    • Time Frame: 30 minutes
    • 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.
  • Complication rate
    • Time Frame: 1 month
    • The complication rate of patients undergoing a screening colonoscopy with segmental and non segmental withdrawal protocol will be reported

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Texas Tech University Health Sciences Center, El Paso
  • Provider of Information About this Clinical Study
    • Principal Investigator: Marc Zuckerman, Professor – Texas Tech University Health Sciences Center, El Paso
  • Overall Official(s)
    • Marc Zuckerman, MD, Principal Investigator, Texas Tech University Health Science Center El Paso

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