Clinical Trial: Conventional Endoscopic Mucosal Resection vs Underwater Resection for Colorectal Non-pedunculated Colorectal Lesions

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

Official Title: Conventional Endoscopic Mucosal Resection (With Submucosal Injection) Versus Underwater Endoscopic Mucosal Resection (Without Submucosal Injection) for Colorectal Non-pedunculated Colorectal Lesions

Brief Summary: Randomized, comparative and prospective study between Conventional Endoscopic Mucosal Resection for the removal of flat or sessile colorectal lesions without previous attempt to resection.

Detailed Summary:
Sponsor: Instituto do Cancer do Estado de São Paulo

Current Primary Outcome:

  • Technical success rate [ Time Frame: three years ]
  • Safety (incidence of complications); [ Time Frame: three years ]
  • Local recurrence. [ Time Frame: Four years ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Resection rate en bloc [ Time Frame: three years ]
  • Time of resection [ Time Frame: Three years ]
  • Sydney resection ratio (characterized by the following equation - lesion size in millimeters divided by the number of fragments) [ Time Frame: Three years ]


Original Secondary Outcome: Same as current

Information By: Instituto do Cancer do Estado de São Paulo

Dates:
Date Received: November 4, 2016
Date Started: February 2017
Date Completion: February 2021
Last Updated: January 12, 2017
Last Verified: January 2017