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Incidence and Clinical Course of Colonoscopy Related Perforation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03833856
Recruitment Status : Recruiting
First Posted : February 7, 2019
Last Update Posted : February 15, 2019
Information provided by (Responsible Party):
Eun Soo Kim, MD, PhD, Kyungpook National University

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

Condition or disease Intervention/treatment
Perforation Colon Procedure: colonoscopy perforation

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
Official Title: Incidence and Risk of Poor Outcomes After Colonoscopy Related Perforation: Result From a Prospective Data Registry
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Intervention Details:
  • Procedure: colonoscopy perforation
    The development of perforation after colonoscopy

Primary Outcome Measures :
  1. Operation [ Time Frame: 1 month ]
    Number of participants who take surgical treatment after perforation

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any patients undergoing colonoscopy who end up with perforation.

Inclusion Criteria:

  • Patients who have a perforation after colonoscopy

Exclusion Criteria:

  • Patients who refuse to be registered.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03833856

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Contact: Eun Young Lee +82-53-200-5968 EUNYOUNG0902@NAVER.COM

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Korea, Republic of
Kyungpook National University Hospital Recruiting
Daegu, Korea, Republic of, 41944
Contact: Eun Soo Kim, MD, PhD    +82-53-200-5879   
Sponsors and Collaborators
Kyungpook National University
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Principal Investigator: Eun Soo Kim, MD Kyungpook National University

Additional Information:

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Responsible Party: Eun Soo Kim, MD, PhD, Professor, Kyungpook National University Identifier: NCT03833856     History of Changes
Other Study ID Numbers: KNUH2019
First Posted: February 7, 2019    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No