ColonoscopyNCT02174601
A Pre-endoscopic Prediction Model for Inadequate Bowel Preparation in Patients Receiving Split Dose Polyethylene Glycol Preparation
An observational study of Colonoscopy, run by Yonsei University at 1 site in South Korea.
Trial summary
After written consent for participating in clinical research studies, all clinical studies conducted to in the one day. The investigators will ask and record about bowel cleansing state in all patients who performed colonoscopy. There is no additional cost and the expected complications. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy
- How many people
- 500 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2014to Aug 2017
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: healthy subjects, more than 20 years old, who admitted to the health promotion center for performing colonoscopy.
Who may be able to join
- Adults over 20 years old
Who cannot join
- Less than 20 years old
- Cardiac, renal, and metabolic dysfunction in patients with serious adverse
- Mental or central nervous system disorders
- Individuals with bwel obstruction
- Individuals who can not read and understand the consent form (literacy, foreign, etc.) However, although individuals with vision / hearing disturbance and deterioration of cognitive abilities, they may participate in the research if can be able to complete the survey with one guardian or the help of researchers.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Gangnam Severance hospital
Seoul, Seoul, 120-752
JAEJUN PARK, MD, 82-2-2019-4371, JAEJPARK@yuhs.ac
About this study
After written consent for participating in clinical research studies, all clinical studies conducted to in the one day. The investigators will ask and record about bowel cleansing state in all patients who performed colonoscopy. There is no additional cost and the expected complications.
Based on answer, the investigators will develop a prediction model for inadequate bowel preparation and prove validation. This model can take the additional measures to subjects predicting improper cleansing. It can contribute to improve the accuracy of the test and reduce the discomfort due to re-performing colonoscopy after re-preparation, as well as cost savings due to reduced frequency of re-colonoscopy Ultimately, it will be able to bring a improvement of the quality of management
- Conditions
- Colonoscopy
- Keywords
- bowel preparation, coolprep, colonoscopy, prediction model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| colonoscopy group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
bowel cleansing state
Based on quality of bowel preparation(bowel cleansing state), we will develop a prediction model for inadequate bowel preparation. And then, assess to efficiency and reducing subjects' satisfaction.
Measured: average 24hours before colonoscopy after taking coolprep
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2014 (estimated)
- Study startApr 2014
- Primary completionAug 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02174601
- Sponsor's protocol ID
- 3-2013-0292
- Status last verified
- Sep 2016
- First submitted
- 23 Jun 2014
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pre-endoscopic Prediction Model for Inadequate Bowel Preparation in Patients Receiving Split Dose Polyethylene Glycol Preparation
- ClinicalTrials.gov ID
- NCT02174601
- Acronym / sponsor ID
- 3-2013-0292
- Conditions
- Colonoscopy
- Keywords
- bowel preparation, coolprep, colonoscopy, prediction model
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 25 Jun 2014 (estimated)
- 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.
After written consent for participating in clinical research studies, all clinical studies conducted to in the one day. The investigators will ask and record about bowel cleansing state in all patients who performed colonoscopy. There is no additional cost and the expected complications.
Based on answer, the investigators will develop a prediction model for inadequate bowel preparation and prove validation. This model can take the additional measures to subjects predicting improper cleansing. It can contribute to improve the accuracy of the test and reduce the discomfort due to re-performing colonoscopy after re-preparation, as well as cost savings due to reduced frequency of re-colonoscopy Ultimately, it will be able to bring a improvement of the quality of management
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| colonoscopy group | – | – |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- healthy subjects, more than 20 years old, who admitted to the health promotion center for performing colonoscopy.
Key inclusion criteria (1 listed)
- Adults over 20 years old
Key exclusion criteria (5 listed)
- Less than 20 years old
- Cardiac, renal, and metabolic dysfunction in patients with serious adverse
- Mental or central nervous system disorders
- Individuals with bwel obstruction
- Individuals who can not read and understand the consent form (literacy, foreign, etc.) However, although individuals with vision / hearing disturbance and deterioration of cognitive abilities, they may participate in the research if can be able to complete the survey with one guardian or the help of researchers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
bowel cleansing state
Time frame: average 24hours before colonoscopy after taking coolprep
Based on quality of bowel preparation(bowel cleansing state), we will develop a prediction model for inadequate bowel preparation. And then, assess to efficiency and reducing subjects' satisfaction.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2016.
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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.
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 Colonoscopy, run by Yonsei University 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 5 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: status not confirmed, as of the sponsor's last update on 7 Sep 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact JAEJUN PARK, MD (82-2-2019-4371, JAEJPARK@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bowel cleansing state (time frame: average 24hours before colonoscopy after taking coolprep). 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 7 Sep 2016.