Endoscopic Resection of Large Colorectal Polyps: An Observational Cohort Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-01

Study Completion Date

2025-05-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Colonic Polyp Colonoscopy Complication Recurrence Duodenal Polyp

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Any patient ≥18 who presents for an upper endoscopy or colonoscopy and who does not have criteria for exclusion
* Patients with a ≥20mm colon polyp
* Patients with a ≥10mm duodenal polyp

Exclusion Criteria

* Patients who are receiving an emergency endoscopy
* Patients with coagulopathy with an elevated INR ≥1.5, or platelets \<50
* Poor bowel preparation
* Pregnancy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes