Bowel PreparationNCT04160104
Pre-procedure Modle Predicts Bowel Preparation Quality Prior Colonoscopy
An observational study of Bowel Preparation and Colonoscopy, run by Air Force Military Medical University, China at 1 site in China.
Trial summary
Bowel preparation is closely llined to the quality of colonoscopy, inadequate bowel preparation (IBP) could lead to higher miss rate of adenomas, patients' discomfort and higher health expense. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Bowel Preparation, Colonoscopy
- What is being tested?
- Questionnaire and Questionnair
- How many people
- 1,600 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2019to 31 Dec 2019
- How long will I take part?
- 7 Days
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This is a prospective study involving two tertiary-centers in China.
Who may be able to join
- Patients aged 18-90 years old who undergoing colonoscopy
Who cannot join
- failed colonoscopy because of technical chanllenge or poor tolerance of patients
- history of colorectal surgery
- prior finding of severe colonic stricture or obstructing tumor
- dysphagia
- compromised swallowing reflex or mental status
- significant gastroparesis or gastric outlet obstruction or ileum
Show all 9Show fewer
- known or suspected bowel obstruction or perforation
- pregnancy
- unable to give informed consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Endoscopic center, Xijing Hospital of Digestive Diseases
Xi'an, 710032
Hui Jia, MD, +862984771536, jiahuifmmu@163.com
Yanglin Pan, MD
About this study
Bowel preparation is closely llined to the quality of colonoscopy, inadequate bowel preparation (IBP) could lead to higher miss rate of adenomas, patients' discomfort and higher health expense. For the patients with possible IBP before the examination, it may be better to cancel the colonoscopy and repeat bowel preparation through modified or enhanced strategies. Thus, it is important to set up a model to predict the quality of bowel preparation individually.
- Conditions
- Bowel Preparation, Colonoscopy
- Being tested
- Questionnaire, Questionnair
- Keywords
- Bowel preparation, BBPS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Patients were asked to complete a questionnaire before colonoscopy. Bowel preparation was subsequently assessed by single endoscopist in each center using Boston bowel preparation quality score (BBPS). Both univariate and multivariate logistic regression models were used to identify high-risk factors associated with IBP and a predicting model with the bowel preparation score (BPS) was developed in the training cohort.
QuestionnairOther
Patients were asked to complete a questionnaire before colonoscopy. The predicting modle established by the training cohort will be used to assessing the preparation of validation cohort. The result will compared with endoscopists assessment of preparation.
| Study group | Role | What they receive |
|---|---|---|
| Training cohort | This cohort was used to establish the bowel preparation score (BPS). Receives: Other: Questionnaire | |
| Validation cohort | This cohort was used to verify the bowel preparation score (BPS). Receives: Other: Questionnair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Boston bowel preparation quality scale
A 10-point scale (0 is worst, 9 is best)
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start1 Apr 2019
- Primary completion30 Nov 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel PreparationStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,600 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanglin Pan, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04160104
- Sponsor's protocol ID
- KT20190827-2
- Status last verified
- Nov 2019
- First submitted
- 8 Nov 2019
- Last updated
- 12 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-procedure Modle Predicts Bowel Preparation Quality Prior Colonoscopy
- ClinicalTrials.gov ID
- NCT04160104
- Acronym / sponsor ID
- KT20190827-2
- Conditions
- Bowel Preparation, Colonoscopy
- Keywords
- Bowel preparation, BBPS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Nov 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 12 Nov 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.
Bowel preparation is closely llined to the quality of colonoscopy, inadequate bowel preparation (IBP) could lead to higher miss rate of adenomas, patients' discomfort and higher health expense. For the patients with possible IBP before the examination, it may be better to cancel the colonoscopy and repeat bowel preparation through modified or enhanced strategies. Thus, it is important to set up a model to predict the quality of bowel preparation individually.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training cohort | – | Other: QuestionnaireThis cohort was used to establish the bowel preparation score (BPS). |
| Validation cohort | – | Other: QuestionnairThis cohort was used to verify the bowel preparation score (BPS). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This is a prospective study involving two tertiary-centers in China.
Key inclusion criteria (1 listed)
- Patients aged 18-90 years old who undergoing colonoscopy
Key exclusion criteria (9 listed)
- failed colonoscopy because of technical chanllenge or poor tolerance of patients
- history of colorectal surgery
- prior finding of severe colonic stricture or obstructing tumor
- dysphagia
- compromised swallowing reflex or mental status
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 |
|---|---|---|
| QuestionnairePatients were asked to complete a questionnaire before colonoscopy. Bowel preparation was subsequently assessed by single endoscopist in each center using Boston bowel preparation quality score (BBPS). Both univariate and multivariate logistic regression models were used to identify high-risk factors associated with IBP and a predicting model with the bowel preparation score (BPS) was developed in the training cohort. | Other | Training cohort |
| QuestionnairPatients were asked to complete a questionnaire before colonoscopy. The predicting modle established by the training cohort will be used to assessing the preparation of validation cohort. The result will compared with endoscopists assessment of preparation. | Other | Validation cohort |
Primary outcome
Boston bowel preparation quality scale
Time frame: 1 hour
A 10-point scale (0 is worst, 9 is best)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2019.
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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 Bowel Preparation and Colonoscopy, run by Air Force Military Medical University, China 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 1 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: status not confirmed, as of the sponsor's last update on 12 Nov 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hui Jia, MD (+86-2984771536, jiahuifmmu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Boston bowel preparation quality scale (time frame: 1 hour). 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 Nov 2019.