Bowel PreparationNCT03704571
A Predictive Model for Inadequate Bowel Preparation
A study testing Polyethylene Glycol in people with Bowel Preparation, run by Shandong University at 1 site in China.
Trial summary
We aimed to develop a predictive model of inadequate bowel preparation and to further validate it by a randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bowel Preparation
- What is being tested?
- Polyethylene Glycol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 429 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2018to 30 Aug 2019
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-75 years undergoing colonoscopy
Who cannot join
- known or suspected bowel obstruction, stricture or perforation
- compromised swallowing reflex or mental status
- severe chronic renal failure(creatinine clearance < 30 ml/min)
- severe congestive heart failure (New York Heart Association class III or IV)
- uncontrolled hypertension (systolic blood pressure > 170 mm Hg, diastolic blood pressure > 100 mm Hg)
- dehydration
Show all 10Show fewer
- disturbance of electrolytes
- pregnancy or lactation
- hemodynamically unstable
- unable to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Predictive Model for Inadequate Bowel Preparation: Development and Validation With a Randomized Controlled Trial
We aimed to develop a predictive model of inadequate bowel preparation and to further validate it by a randomized controlled trial.
- Conditions
- Bowel Preparation
- Being tested
- Polyethylene Glycol
- Keywords
- adenoma, bowel preparation, colonoscopy, predictive model, randomized controlled trial
- Medical subject headings
- Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyethylene GlycolDrug
In the Tailored group, high-risk people are given intensified bowel preparation regimens, low-risk people are given routine regimens.
In the control group, all the patients are given routine regimens.
| Study group | Role | What they receive |
|---|---|---|
| Tailored Group | Experimental | In the tailored group, high-risk patients are instructed to drink the first 2 L of Polyethylene Glycol (PEG) at 19:00-21:00 hours on the day before colonoscopy at a rate of 250 ml every 15 min. On the day of the procedure, they take another 2 L PEG 4-6 h before colonoscopy. The low-risk patients were given a standard dose of 2 L PEG 4-6 h before colonoscopy. Receives: Drug: Polyethylene Glycol |
| Control Group | Active comparator | In the control group, all the patients drink single dose of 2 l Polyethylene Glycol (PEG) 4-6 h before colonoscopy at a rate of 250 ml every 15 min. Receives: Drug: Polyethylene Glycol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Bowel Preparation
The quality of bowel preparation is evaluated using BBPS.
Measured: 10 months
Secondary outcomes (3)
Adenoma Detection Rate
The proportion of patients from whom at least one adenoma can be detected.
Measured: 10 months
Polyp Detection Rate
The proportion of patients from whom at least one polyp can be detected.
Measured: 10 months
Adverse Events
Including nausea, bloating, stomachache, vomiting, vertigo and belching and so on.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start1 Nov 2018
- Primary completion31 Jul 2019
- Study completion30 Aug 2019
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 429 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiuli Zuo, Shandong University
- Investigators
- Xiuli Zuo, MD, PhD, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03704571
- Sponsor's protocol ID
- 2018SDU-QILU-G111
- Status last verified
- Oct 2019
- First submitted
- 10 Oct 2018
- Last updated
- 1 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 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Predictive Model for Inadequate Bowel Preparation: Development and Validation With a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03704571
- Acronym / sponsor ID
- 2018SDU-QILU-G111
- Conditions
- Bowel Preparation
- Keywords
- adenoma, bowel preparation, colonoscopy, predictive model, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 429 participants (actual)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 15 Oct 2018 (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.
We aimed to develop a predictive model of inadequate bowel preparation and to further validate it by a randomized controlled trial.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tailored Group | Experimental | Drug: Polyethylene GlycolIn the tailored group, high-risk patients are instructed to drink the first 2 L of Polyethylene Glycol (PEG) at 19:00-21:00 hours on the day before colonoscopy at a rate of 250 ml every 15 min. On the day of the procedure, they take another 2 L PEG 4-6 h before colonoscopy. The low-risk patients were given a standard dose of 2 L PEG 4-6 h before colonoscopy. |
| Control Group | Active comparator | Drug: Polyethylene GlycolIn the control group, all the patients drink single dose of 2 l Polyethylene Glycol (PEG) 4-6 h before colonoscopy at a rate of 250 ml every 15 min. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 18-75 years undergoing colonoscopy
Key exclusion criteria (10 listed)
- known or suspected bowel obstruction, stricture or perforation
- compromised swallowing reflex or mental status
- severe chronic renal failure(creatinine clearance < 30 ml/min)
- severe congestive heart failure (New York Heart Association class III or IV)
- uncontrolled hypertension (systolic blood pressure > 170 mm Hg, diastolic blood pressure > 100 mm Hg)
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 |
|---|---|---|
| Polyethylene GlycolIn the Tailored group, high-risk people are given intensified bowel preparation regimens, low-risk people are given routine regimens. In the control group, all the patients are given routine regimens. | Drug | Control Group, Tailored Group |
Primary outcome
Quality of Bowel Preparation
Time frame: 10 months
The quality of bowel preparation is evaluated using BBPS.
3 secondary outcomes
Adenoma Detection Rate
Time frame: 10 months
Polyp Detection Rate
Time frame: 10 months
Adverse Events
Time frame: 10 months
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 1 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.
Xiuli Zuo, MD, PhD 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?
A study testing Polyethylene Glycol in people with Bowel Preparation, 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 1 inclusion and 10 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 1 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?
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?
Quality of Bowel Preparation (time frame: 10 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 1 Nov 2019.