Protocol Summary

Protocol No.: OCR24544

Sponsor Protocol No.: IRB201901596

Protocol Title.: Endoscopic Resection of Large Colorectal Polyps: An Observational Cohort Study

Principal Investigator: Yang, Dennis

Objective: This protocol describes a prospective cohort study. It addresses an important challenge in the prevention of colorectal cancer: how to safely and effectively remove large polyps.

Description: Over recent years, a number of studies have been published that have highlighted factors associated with improved efficacy and safety of large polyp resection. Almost all of these studies originate from one large Australian cohort. It is unclear, whether the results are generalizable to other populations. It is important to understand if these findings can be duplicated, to further build on the gained knowledge. At the same time the technology of endoscopic resection is evolving. Established in 2012, the Large Polyp Study group aims to prospectively examine outcomes related to endoscopic large polyp removal. Enrollment of an ongoing randomized trial of 920 patients has just been completed and a second trial is planned. The primary aim of both trials is to understand whether a specific intervention will reduce the risk of adverse events. The added observational study will complement the trials in different ways: It will enroll patients who might not have been eligible for the trials and allow the application of other resection techniques. The observational study will therefore better represent the average patient who undergoes resection of a large polyp. Furthermore, it will add sample size to examine secondary outcomes with greater power. This is a continuation of NCT01936948 (Safety of Endoscopic Resection of Large Colorectal Polyps: A Randomized Trial) as a observational cohort. The continuation was approved by the institutional IRB as part of the initial RCT. At this point the investigators document the observational arm as its own study in this registry.

Phase: N/A (Cancer Prevention)

Age Group: Adult

Age: 18 Years - N/A

Gender: All

Scope: National

Detailed Eligibility:

Any patient who is known to have a large polyp and are referred for resection of the polyp.

Applicable Conditions:

  • Colon Cancer
  • Participation Institution:

  • UF Gainesville : April Goddard
  • Contact:
    April Goddard
    Phone: +1 352-273-9483
    Email: April.Goddard@medicine.ufl.edu

    More Information: View study listing on ClinicialTrials.gov http://www.clinicaltrials.gov/ct2/show/NCT04220905