Perforation ColonNCT03833856
Incidence and Clinical Course of Colonoscopy Related Perforation
An observational study of Perforation Colon, run by Kyungpook National University Hospital at 1 site in South Korea.
Trial summary
This study aims to investigate the incidence and clinical course of colonoscopy related perforation based on the result of a prospective registry. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perforation Colon
- What is being tested?
- colonoscopy perforation
- Type of treatment
- Surgery or procedure
- How many people
- 58 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2017to Jan 2021
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any patients undergoing colonoscopy who end up with perforation.
Who may be able to join
- Patients who have a perforation after colonoscopy
Who cannot join
- Patients who refuse to be registered.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Perforation Colon
- Being tested
- colonoscopy perforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colonoscopy perforationProcedure or surgery
The development of perforation after colonoscopy
What is being measured
The primary outcome is the main question the study is designed to answer.
Operation
Number of participants who take surgical treatment after perforation
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2019
- Study start1 Jan 2017
- Primary completionAug 2020
- Study completionJan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perforation ColonStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eun Soo Kim, MD, PhD, Kyungpook National University Hospital
- Investigators
- Eun Soo Kim, MD, Principal investigator, Kyungpook National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03833856
- Sponsor's protocol ID
- KNUH2019
- Status last verified
- Jan 2021
- First submitted
- 6 Feb 2019
- Last updated
- 12 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Risk of Poor Outcomes After Colonoscopy Related Perforation: Result From a Prospective Data Registry
- ClinicalTrials.gov ID
- NCT03833856
- Acronym / sponsor ID
- KNUH2019
- Conditions
- Perforation Colon
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Kyungpook National University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- Aug 2020 (actual)
- Study completion
- Jan 2021 (actual)
- First posted
- 7 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate the incidence and clinical course of colonoscopy related perforation based on the result of a prospective registry.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patients undergoing colonoscopy who end up with perforation.
Key inclusion criteria (1 listed)
- Patients who have a perforation after colonoscopy
Key exclusion criteria (1 listed)
- Patients who refuse to be registered.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| colonoscopy perforationThe development of perforation after colonoscopy | Procedure or surgery | – |
Primary outcome
Operation
Time frame: 1 month
Number of participants who take surgical treatment after perforation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eun Soo Kim, MD principal investigator
Kyungpook National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perforation Colon, run by Kyungpook National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operation (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2021.