Clinical Trial: Usefulness of Endocuff in the Adenoma Detection Rate. Comparative Study

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Usefulness of Endocuff in the Adenoma Detection Rate. A Randomized Clinical Trial

Brief Summary:

Colorectal cancer (CRC) is one of the leading causes of cancer death worldwide. The cumulative risk of developing CRC is about 6% lifelong.

The benefit of screening colonoscopy depends on the detection and removal of all adenomas, however, some of these may be difficult to detect.

The "endocuff" (EC) is a polymer sleeve which joins the tip of the colonoscope to improve the image viewing of the mucosa during colonoscopy procedure.

There is insufficient evidence of the usefulness of endocuf


Detailed Summary: All patients requiring colonoscopy for screening and who agree to participate in the study will be included and randomized them to make an standard colonoscopy or colonoscopy with endocuff, for randomization system will be used in balanced blocks of 4, created on the page randomization.com.
Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Current Primary Outcome:

  • Adenoma detection rate [ Time Frame: 30 minutes ]
    Percentage of adenomas detected during colonoscopy
  • Measurement of the polyp detection rate [ Time Frame: 30 minutes ]
    Percentage of polyps detected during colonoscopy


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Cecal intubation rate [ Time Frame: 30 minutes ]
    Percentage of cecal intubation
  • ileal intubation rate [ Time Frame: 10 minutes ]
    Percentage of ileal intubation
  • Difficulty performing polypectomy [ Time Frame: 10 minutes ]
    When the endoscopist requiring special maneuvers to perform polypectomy
  • Complications during colonoscopy [ Time Frame: One week ]
    When patients require special handling during or immediately subsequent colonoscopy


Original Secondary Outcome: Same as current

Information By: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Dates:
Date Received: March 9, 2015
Date Started: September 2014
Date Completion:
Last Updated: March 12, 2015
Last Verified: September 2014