Clinical Trial: Impact of Proximal Colon Retroflexion in Colorectal Cancer Screening Programme

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Impact of Proximal Colon Retroflexion in Colorectal Cancer Screening Programme: Randomized Trial

Brief Summary: Colorectal cancer (CRC) is the most common tumor and the second leading cause of death in the Western world. The decrease in incidence and mortality by CRC in the population undergoing screening has been observed. Colonoscopy is the recommended method for detecting tumors in early stages, as well as identifying and resecting adenomatous polyps, which are the precursor lesions of most CRCs. Colonoscopy should be of high quality to decrease incidence and mortality by CRC and avoid interval cancer. The literature shows that colonoscopy does not prevent right colon lesions in the same way as the left colon lesions, with most of the interval cancers located in the right colon. Studies published so far show an increase in the adenomas detection rate (ADT) in the right colon in a second visualization of this segment and an increase between 2 and 10% if this second examination is performed with the proximal retroflexion maneuver .Retroflexion is a safe maneuver in expert endoscopists. The aim of our study is to evaluate the ADT in right colon by means of a second visualization by performing proximal retroflexion or second frontal visualization at random in the CCR screening population.

Detailed Summary:
Sponsor: Hospital del Río Hortega

Current Primary Outcome: Proximal retroflexion improve adenoma detection rate in colorectal cancer screening [ Time Frame: through study completion, an average of 1 year ]

Determine whether to perform retroflexion proximal improves adenoma detection rate in the right colon versus forward vision in population screening colorectal cancer with medium risk with immune blood test positive stool


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Second look for right colon improve adenoma detection rate [ Time Frame: through study completion, an average of 1 year ]
    Determine if a second look: retroflexion proximal or forward view improve adenoma detection rate
  • Rate of retroflexion related adverse events [ Time Frame: through study completion, an average of 1 year ]
  • Rate of retroflexion proximal adverse events with a pediatric colonoscopy [ Time Frame: through study completion, an average of 1 year ]
  • Pre-procedure factors [ Time Frame: through study completion, an average of 1 year ]
    To analyze pre-procedure factors that may influence the prevalence of precursor lesions in the colon: age, sex, race, alcohol, smoking habit and the value of SOH, in which more detailed explorations should be performed using proximal retroflexion


Original Secondary Outcome: Same as current

Information By: Hospital del Río Hortega

Dates:
Date Received: January 25, 2017
Date Started: February 2017
Date Completion: December 31, 2017
Last Updated: February 1, 2017
Last Verified: January 2017