Clinical Trial: The Utility of Cap Colonoscopy in Increasing Adenoma Detection Rate

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: The Utility of Cap Colonoscopy in Increasing Adenoma Detection Rate

Brief Summary: This is a research study about the usefulness of transparent cap during screening colonoscopy. The purpose of the research is to test the usefulness of adding small cap to the tip of the colonoscope. the investigators hypothesis is that Cap assisted colonoscopy will improve the detection of adenomatous polyps (polyps which can become colon cancer later on) in comparison to the standard colonoscopy.

Detailed Summary:

This is a prospective, randomized trial comparing the adenoma detection rate between Hispanic patients undergoing a screening colonoscopy with a conventional colonoscope or with a cap-assisted colonoscopy. The aims of the study are:

  1. Compare ADR between Hispanic patients undergoing a screening colonoscopy with and without cap.
  2. Compare the overall polyp detection rate between Hispanic patients undergoing a screening colonoscopy with and without cap.
  3. Compare the cecal intubation rate and cecal intubation time between standard colonoscopy and cap assisted colonoscopy.
  4. Compare the complication rate between standard colonoscopy and cap assisted colonoscopy.

Sponsor: Texas Tech University Health Sciences Center, El Paso

Current Primary Outcome: ADR differences in Hispanic patients undergoing a screening colonoscopy with and without cap. [ Time Frame: 1 year ]

1. Compare ADR between Hispanic patients undergoing a screening colonoscopy with and without cap.


Original Primary Outcome: ADR differences in Hispanic patients undergoing a screening colonoscopy with and without cap. [ Time Frame: 1 year ]

Current Secondary Outcome:

  • Polyp detection rate in Hispanic patients undergoing a screening colonoscopy with and without cap. [ Time Frame: 1 year ]
    2. Compare overall polyp detection rate between Hispanic patients undergoing a screening colonoscopy with and without cap.
  • Cecal intubation rate and time in standard colonoscopy vs. cap assisted colonoscopy. [ Time Frame: 1 year ]
    1. Compare the cecal intubation rate and cecal intubation time between standard colonoscopy and cap assisted colonoscopy.
  • Complication rate in standard colonoscopy vs. cap assisted colonoscopy. [ Time Frame: 1 year ]
    2. Compare the complication rate between standard colonoscopy and cap assisted colonoscopy.


Original Secondary Outcome:

  • Polyp detection rate in Hispanic patients undergoing a screening colonoscopy with and without cap. [ Time Frame: 1 year ]
  • Cecal intubation rate and time in standard colonoscopy vs. cap assisted colonoscopy. [ Time Frame: 1 year ]
  • Complication rate in standard colonoscopy vs. cap assisted colonoscopy. [ Time Frame: 1 year ]


Information By: Texas Tech University Health Sciences Center, El Paso

Dates:
Date Received: May 14, 2012
Date Started: March 29, 2012
Date Completion:
Last Updated: April 24, 2017
Last Verified: April 2017