ColonoscopyNCT04607161
External Validation of Models for Predicting Inadequate Bowel Preparation
An observational study of Colonoscopy and Predictive Model, run by Ningbo No. 1 Hospital at 1 site in China.
Trial summary
In order to obtain the risk level of patients with intestinal insufficiency through simple indicators, many foreign scholars have studied and developed their own prediction models. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonoscopy, Predictive Model, External Validation
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2020to 31 Dec 2020
- 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: Adult patients undergoing colonoscopy
Who may be able to join
- patients undergoing colonoscopy.
- patients older than 18 years.
Who cannot join
- Emergency colonoscopy.
- Have a serious medical condition, such as heart failure, acute liver failure, severe kidney disease (dialysis or predialysis patients) or New York heart association class iii-iv.
- Pregnant or breastfeeding.
- No bowel preparation or poor compliance (no bowel preparation as instructed or laxatives < 90% of prescribed dose).
- Refuse to sign informed consent.
- The patient was rescheduled after the previous colonoscopy due to insufficient bowel preparation.
Show all 9Show fewer
- Temporarily change to colonoscopy for other reasons.
- Incomplete colonoscopy due to insufficient parenteral preparation.
- Lack of complete data.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: External Validation of Two Prediction Models for Adequate Bowel Preparation in Asia: A Prospective Study
In order to obtain the risk level of patients with intestinal insufficiency through simple indicators, many foreign scholars have studied and developed their own prediction models. However, the current guideline indicates that there is insufficient evidence to recommend the use of a specialized predictive model for clinical practice.There are few studies on external validation of existing prediction models.
- Conditions
- Colonoscopy, Predictive Model, External Validation
- Being tested
- no intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
discrimination
Compare the area under the curve (AUC) between predictive models and acutal bowel preparation.
Measured: cross-sectional analyses in 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start1 Aug 2020
- Primary completion1 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ColonoscopyStudies 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
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ningbo No. 1 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04607161
- Sponsor's protocol ID
- IBPV-V1.0
- Status last verified
- Jun 2021
- First submitted
- 25 Oct 2020
- Last updated
- 30 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yuan X, Gao H, Liu C, Wang W, Xie J, Zhang Z, Xu L. External validation of two prediction models for adequate bowel preparation in Asia: a prospective study. Int J Colorectal Dis. 2022 Jun;37(6):1223-1229. doi: 10.1007/s00384-022-04156-0. Epub 2022 Apr 25.
PubMed 35467123
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Validation of Two Prediction Models for Adequate Bowel Preparation in Asia: A Prospective Study
- ClinicalTrials.gov ID
- NCT04607161
- Acronym / sponsor ID
- IBPV-V1.0
- Conditions
- Colonoscopy, Predictive Model, External Validation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Ningbo No. 1 HospitalUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 29 Oct 2020 (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.
In order to obtain the risk level of patients with intestinal insufficiency through simple indicators, many foreign scholars have studied and developed their own prediction models. However, the current guideline indicates that there is insufficient evidence to recommend the use of a specialized predictive model for clinical practice.There are few studies on external validation of existing prediction models.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing colonoscopy
Key inclusion criteria (2 listed)
- patients undergoing colonoscopy.
- patients older than 18 years.
Key exclusion criteria (9 listed)
- Emergency colonoscopy.
- Have a serious medical condition, such as heart failure, acute liver failure, severe kidney disease (dialysis or predialysis patients) or New York heart association class iii-iv.
- Pregnant or breastfeeding.
- No bowel preparation or poor compliance (no bowel preparation as instructed or laxatives < 90% of prescribed dose).
- Refuse to sign informed consent.
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 |
|---|---|---|
| no interventionno intervention | Other | – |
Primary outcome
discrimination
Time frame: cross-sectional analyses in 2020
Compare the area under the curve (AUC) between predictive models and acutal bowel preparation.
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 30 Jun 2021.
- Derived from this study: PubMed 35467123Yuan X, Gao H, Liu C, Wang W, Xie J, Zhang Z, Xu L. External validation of two prediction models for adequate bowel preparation in Asia: a prospective study. Int J Colorectal Dis. 2022 Jun;37(6):1223-1229. doi: 10.1007/s00384-022-04156-0. Epub 2022 Apr 25.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Predictive Model, run by Ningbo No. 1 Hospital at 1 site in China.
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 2 inclusion and 9 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 30 Jun 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 China. 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?
discrimination (time frame: cross-sectional analyses in 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04607161, which also lists 1 linked publication.
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 30 Jun 2021.