Bowel Cleansing QualityNCT02726893
A Predictive Model for Inadequate Bowel Preparation Before Colonoscopy: Development and Validation
An observational study of Bowel Cleansing Quality and Predictors, run by Shandong University at 1 site in China.
Trial summary
About 30% of patients were reported to suffer inadequate bowel preparation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bowel Cleansing Quality, Predictors, Colonoscopy
- How many people
- 1,504 participants
- Where
- 1 siteChina
- Study dates
- Apr 2016to Feb 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. patients undergoing colonoscopy. 2. patients older than 18 years.
Who may be able to join
- patients undergoing colonoscopy.
- patients older than 18 years.
Who cannot join
- patients referred for emergency colonoscopy.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, 250012
About this study
About 30% of patients were reported to suffer inadequate bowel preparation.
Read the detailed description
Risk factors, such as diabetes, constipation, history of intra-abdominal or pelvic surgery, etc, have been demonstrated to be important predictors for inadequate bowel preparation. The aim of the study is to create and verify a predictive model for inadequate bowel preparation in Chinese.
- 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
| Study group | Role | What they receive |
|---|---|---|
| patients undergoing colonoscopy | patients undergoing colonoscopy were observed in terms of the bowel preparation quality which is measured by Boston Bowel Preparation Scale (BBPS). Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
inadequate bowel preparation, defined as a Boston Bowel Preparation Scale (BBPS) score.
inadequate bowel preparation
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel Cleansing QualityStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,504 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanqing Li, Shandong University
- Investigators
- Li Yanqing, PhD,MD, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02726893
- Sponsor's protocol ID
- 2016SDU-QILU-01
- Status last verified
- Mar 2017
- First submitted
- 25 Mar 2016
- Last updated
- 20 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Predictive Model for Inadequate Bowel Preparation Before Colonoscopy: Development and Validation
- ClinicalTrials.gov ID
- NCT02726893
- Acronym / sponsor ID
- 2016SDU-QILU-01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,504 participants (actual)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 4 Apr 2016 (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.
About 30% of patients were reported to suffer inadequate bowel preparation.
Detailed description
Risk factors, such as diabetes, constipation, history of intra-abdominal or pelvic surgery, etc, have been demonstrated to be important predictors for inadequate bowel preparation. The aim of the study is to create and verify a predictive model for inadequate bowel preparation in Chinese.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients undergoing colonoscopy | – | Other: no interventionpatients undergoing colonoscopy were observed in terms of the bowel preparation quality which is measured by Boston Bowel Preparation Scale (BBPS). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. patients undergoing colonoscopy. 2. patients older than 18 years.
Key inclusion criteria (2 listed)
- patients undergoing colonoscopy.
- patients older than 18 years.
Key exclusion criteria (1 listed)
- patients referred for emergency colonoscopy.
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 intervention | Other | patients undergoing colonoscopy |
Primary outcome
inadequate bowel preparation, defined as a Boston Bowel Preparation Scale (BBPS) score.
Time frame: 5 months
inadequate 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 20 Mar 2017.
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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.
Li Yanqing, PhD,MD principal investigator
Qilu Hospital of Shandong University
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 Cleansing Quality and Predictors, run by Shandong University 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 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 20 Mar 2017. 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?
inadequate bowel preparation, defined as a Boston Bowel Preparation Scale (BBPS) score. (time frame: 5 months). 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 20 Mar 2017.