Clinical Trial: Evaluation of Colonic Diminutive Polyps With Electronic Filters

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

Official Title: "Remove and Discard" Policy in Colonic Diminutive Polyps: is it Always Safe?

Brief Summary:

Diminutive polyps, measuring between 1 and 5 mm, represent the vast majority of colorectal polyps encountered during colonoscopy. Since the chance of harboring advanced adenoma or carcinoma in this kind of polyps is very low, a "remove and discard" technique has been proposed.

The differentiation between adenoma/non adenoma polyps is based on the use of endoscopes equipped with high definition, magnification and optical filters.


Detailed Summary:

Any diminutive polyps encountered during a colonoscopy will be examined with the use of electronic filters and magnification and assigned by the endoscopist to a adenoma/non adenoma category, resected and retrieved: a follow up surveillance period will be assigned on the basis of the endoscopic appearance of the polyps.

Each polyp will then be sent separately to Pathology for the histologic evaluation, and a surveillance interval period will be determined accordingly.


Sponsor: Ospedale Cardinal Massaia

Current Primary Outcome: Percentage of accordance between endoscopic and histologic assignment of the polyps to the adenoma/non adenoma category [ Time Frame: 1 year ]

All the retrieved polyps will be examined and the percentage of accordance between the endoscopic and histologic diagnosis will be determined


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Cost savings expressed in dollars between the "remove and discard" technique and histologic examination of samples [ Time Frame: 1 year ]
    The cost of histologic examination for any polyp retrieved will be determined according to the current italian tariff of the procedure and the savings will be calculate
  • Percentage of concordance between the surveillance periods, determined on the basis of the endoscopic and histologic evaluation of the polyps [ Time Frame: 1 year ]
    For any patient, there will be an analysis of the surveillance period assigned both by the endoscopist and the pathologist in order to determine the percentage of accordance between the two.


Original Secondary Outcome: Same as current

Information By: Ospedale Cardinal Massaia

Dates:
Date Received: March 8, 2016
Date Started: May 2016
Date Completion: December 2016
Last Updated: March 11, 2016
Last Verified: March 2016