Incidence and Clinical Course of Colonoscopy Related Perforation

January 8, 2021 updated by: Eun Soo Kim, MD, PhD, Kyungpook National University Hospital

Incidence and Risk of Poor Outcomes After Colonoscopy Related Perforation: Result From a Prospective Data Registry

This study aims to investigate the incidence and clinical course of colonoscopy related perforation based on the result of a prospective registry.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In each endoscopy unit from participating hospital, there is a alarm system focusing on the development of perforation. Therefore, perforation cases will not be missed from the registry.

Study Type

Observational

Enrollment (Actual)

58

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Daegu, Korea, Republic of, 41944
        • Kyungpook National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Any patients undergoing colonoscopy who end up with perforation.

Description

Inclusion Criteria:

  • Patients who have a perforation after colonoscopy

Exclusion Criteria:

  • Patients who refuse to be registered.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operation
Time Frame: 1 month
Number of participants who take surgical treatment after perforation
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyungpook National University Hospital

Investigators

  • Principal Investigator: Eun Soo Kim, MD, Kyungpook National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2017

Primary Completion (ACTUAL)

August 1, 2020

Study Completion (ACTUAL)

January 1, 2021

Study Registration Dates

First Submitted

February 6, 2019

First Submitted That Met QC Criteria

February 6, 2019

First Posted (ACTUAL)

February 7, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 12, 2021

Last Update Submitted That Met QC Criteria

January 8, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • KNUH2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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