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Completed

NCT Number: NCT02132455

The Utility of Timed Segmental Withdrawal During Screening Colonoscopy

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.

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Key information

Conditions

Colonoscopy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Texas Tech University Health Science Center El Paso

El Paso, Texas, 79905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

colonoscopy

Procedure

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

Primary outcomes

  1. 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.

  2. 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 outcomes

  1. 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

    • 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.

  2. 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

Sponsors and collaborators

Lead sponsor

Texas Tech University Health Sciences Center, El Paso

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
May 7, 2014
Registry last updated
May 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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