NCT03833856

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 7, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

January 12, 2021

Status Verified

January 1, 2021

Enrollment Period

3.6 years

First QC Date

February 6, 2019

Last Update Submit

January 8, 2021

Conditions

Perforation Colon

Outcome Measures

Primary Outcomes (1)

  • Operation

    Number of participants who take surgical treatment after perforation

    1 month

Interventions

colonoscopy perforationPROCEDURE

The development of perforation after colonoscopy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any patients undergoing colonoscopy who end up with perforation.

You may qualify if:

  • Patients who have a perforation after colonoscopy

You may not qualify if:

  • Patients who refuse to be registered.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyungpook National University Hospital

Daegu, 41944, South Korea

Location

Study Officials

  • Eun Soo Kim, MD

    Kyungpook National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 6, 2019

First Posted

February 7, 2019

Study Start

January 1, 2017

Primary Completion

August 1, 2020

Study Completion

January 1, 2021

Last Updated

January 12, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)