Bowel Cleansing QualityNCT03142854
Efficacy of Tailored Bowel Preparation Strategy Guided by a Predictive Model
A study testing Polyethylene Glycol (PEG) in people with Bowel Cleansing Quality and Colonoscopy, run by Shandong University at 1 site in China.
Trial summary
About 30% of patients were reported to suffer inadequate bowel preparation. So, it is desirable to prescribe personalized regimen according to patient's personal characteristics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bowel Cleansing Quality, Colonoscopy
- What is being tested?
- Polyethylene Glycol (PEG)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 429 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2017to 30 Aug 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients aged 18 or older
- patients undergoing colonoscopy
Who cannot join
- patients with a history of colorectal surgery
- patients with severe colonic stricture or obstructing tumor
- patients with dysphagia
- patients with compromised swallowing reflex or mental status
- patients with significant gastroparesis or gastric outlet obstruction
- patients with known or suspected bowel obstruction or perforation
Show all 15Show fewer
- patients with severe chronic renal failure (creatinine clearance<30 ml/min)
- patients with severe chronic renal failure (creatinine clearance<30 ml/min)
- patients with uncontrolled hypertension (systolic blood pressure>170 mm Hg, diastolic blood pressure>100 mm Hg)
- patients with inflammatory bowel disease or megacolon
- patients with dehydration
- patients with dehydration
- patients with pregnancy or lactation
- patients hemodynamically unstable
- patients unable to give informed consent
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Gastroenterology, Qilu Hospital, Shandong University
Ji'nan, Shandong, 250012
About this study
Official title: Efficacy of Tailored Bowel Preparation Strategy Guided by a Predictive Model: a Randomized Controlled Study
About 30% of patients were reported to suffer inadequate bowel preparation. So, it is desirable to prescribe personalized regimen according to patient's personal characteristics.
Read the detailed description
Colonoscopy is currently the main approach for detecting mucosal abnormalities in the whole colon. Inadequate bowel preparation is the predominant threaten to the efficacy of colonoscopy.Unfortunately, about 30% of patients were reported to suffer inadequate bowel preparation. In order to improve adequate bowel preparation rate, it is desirable to prescribe personalized regimen according to patient characteristics. We intend to create and verify a predictive model for inadequate bowel preparation. Then, in order to improve adequate bowel preparation rate, we aim to establish a bowel preparation strategy guided by the predicted model and verify it.
- Conditions
- Bowel Cleansing Quality, Colonoscopy
- Being tested
- Polyethylene Glycol (PEG)
- Keywords
- bowel preparation, colonoscopy, predictive model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyethylene Glycol (PEG)Drug
participants in Group A and Low risk patients in group B are given standard regimen: 2 L Polyethylene Glycol (PEG) regimen.
Polyethylene Glycol (PEG)Drug
Also called High-dose Bowel Preparation Regimen
High risk patients in Group B will receive 4 L Polyethylene Glycol (PEG) regimen.
| Study group | Role | What they receive |
|---|---|---|
| Group A: standard group | Active comparator | Participants are given standard regimen: 2 L Polyethylene Glycol (PEG) regimen. Receives: Drug: Polyethylene Glycol (PEG) |
| Group B: tailored group | Experimental | Participants are given personalized regimens for bowel preparation according to the the predictive model( a model which grades patients as low or high risk according to risk factors such as age, body mass index≧ 30 kg/m2, diabetes, constipation, pelvic surgery and tricyclic antidepressants usage).
Low risk patients are given standard regimen: 2 L Polyethylene Glycol (PEG) regimen; High risk patients are given standard regimen: 4 L Polyethylene Glycol (PEG) regimen. Receives: Drug: Polyethylene Glycol (PEG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
adequate bowel preparation rates between 2 groups.
adequate bowel preparation rates between 2 groups according to Boston Bowel Preparation Scale (BBPS)
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start1 May 2017
- Primary completion30 Jul 2017
- Study completion30 Aug 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to group A or B. Participants of group A are given normal bowel preparation, while participants of group B are given personalized regimens according to a predictive model we have established.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 429 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
- NCT03142854
- Sponsor's protocol ID
- 2017SDU-QILU-01
- Status last verified
- Sep 2017
- First submitted
- 3 May 2017
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: individual participant data of this trial will be shared when necessary
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Tailored Bowel Preparation Strategy Guided by a Predictive Model: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03142854
- Acronym / sponsor ID
- 2017SDU-QILU-01
- Conditions
- Bowel Cleansing Quality, Colonoscopy
- Keywords
- bowel preparation, colonoscopy, predictive model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 429 participants (actual)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 30 Jul 2017 (actual)
- Study completion
- 30 Aug 2017 (actual)
- First posted
- 8 May 2017 (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.
About 30% of patients were reported to suffer inadequate bowel preparation. So, it is desirable to prescribe personalized regimen according to patient's personal characteristics.
Detailed description
Colonoscopy is currently the main approach for detecting mucosal abnormalities in the whole colon. Inadequate bowel preparation is the predominant threaten to the efficacy of colonoscopy.Unfortunately, about 30% of patients were reported to suffer inadequate bowel preparation. In order to improve adequate bowel preparation rate, it is desirable to prescribe personalized regimen according to patient characteristics. We intend to create and verify a predictive model for inadequate bowel preparation. Then, in order to improve adequate bowel preparation rate, we aim to establish a bowel preparation strategy guided by the predicted model and verify it.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to group A or B. Participants of group A are given normal bowel preparation, while participants of group B are given personalized regimens according to a predictive model we have established.
| Arm | Type | Receives |
|---|---|---|
| Group A: standard group | Active comparator | Drug: Polyethylene Glycol (PEG)Participants are given standard regimen: 2 L Polyethylene Glycol (PEG) regimen. |
| Group B: tailored group | Experimental | Drug: Polyethylene Glycol (PEG)Participants are given personalized regimens for bowel preparation according to the the predictive model( a model which grades patients as low or high risk according to risk factors such as age, body mass index≧ 30 kg/m2, diabetes, constipation, pelvic surgery and tricyclic antidepressants usage). Low risk patients are given standard regimen: 2 L Polyethylene Glycol (PEG) regimen; High risk patients are given standard regimen: 4 L Polyethylene Glycol (PEG) regimen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients aged 18 or older
- patients undergoing colonoscopy
Key exclusion criteria (15 listed)
- patients with a history of colorectal surgery
- patients with severe colonic stricture or obstructing tumor
- patients with dysphagia
- patients with compromised swallowing reflex or mental status
- patients with significant gastroparesis or gastric outlet obstruction
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 Glycol (PEG)participants in Group A and Low risk patients in group B are given standard regimen: 2 L Polyethylene Glycol (PEG) regimen. | Drug | Group A: standard group |
| Polyethylene Glycol (PEG)Also: High-dose Bowel Preparation RegimenHigh risk patients in Group B will receive 4 L Polyethylene Glycol (PEG) regimen. | Drug | Group B: tailored group |
Primary outcome
adequate bowel preparation rates between 2 groups.
Time frame: 4 months
adequate bowel preparation rates between 2 groups according to Boston Bowel Preparation Scale (BBPS)
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 11 Sep 2017.
- Individual participant dataSharing planned: Undecided. individual participant data of this trial will be shared when necessary
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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?
A study testing Polyethylene Glycol (PEG) in people with Bowel Cleansing Quality and Colonoscopy, 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 15 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 11 Sep 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?
adequate bowel preparation rates between 2 groups. (time frame: 4 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 11 Sep 2017.