Bowel PreparationNCT03765216
Efficacy of Tailored Bowel Preparation Strategy: A Randomized Controlled Study
A study testing 2L Polyethylene Glycol (PEG) and 4L Polyethylene Glycol (PEG) in people with Bowel Preparation 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 to 80 years
- Conditions the study is for
- Bowel Preparation, Colonoscopy
- What is being tested?
- 2L Polyethylene Glycol (PEG) and 4L Polyethylene Glycol (PEG)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 15 Mar 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 80 years
- 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
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- 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
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 improve adequate bowel preparation rate by deploying tailored bowel preparation strategy. There are many predictive factors of inadequate bowel preparation such as obesity, constipation, abdominal surgery and so on. By recognizing these risk factors of the patients , we can prescribe the patients with higher dose of bowel cleansing regimen to improve bowel preparation quality.
- Conditions
- Bowel Preparation, Colonoscopy
- Being tested
- 2L Polyethylene Glycol (PEG), 4L Polyethylene Glycol (PEG)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2L Polyethylene Glycol (PEG)Drug
Also called Standard
Participants in Group A and Low risk patients in group B are given standard regimen: 2 L Polyethylene Glycol (PEG) regimen
4L Polyethylene Glycol (PEG)Drug
Also called High dose
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: 2L 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: 2L Polyethylene Glycol (PEG); Drug: 4L Polyethylene Glycol (PEG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequate bowel preparation rates
Adequate bowel preparation rates between 2 groups according to Boston Bowel Preparation Scale (BBPS)
Measured: 2 months
Secondary outcomes (1)
Polyp detection rate
Polyp detection rates between 2 groups
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start1 Jan 2019 (estimated)
- Primary completion28 Feb 2019 (estimated)
- Study completion15 Mar 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 600 participants (estimated)
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
- NCT03765216
- Sponsor's protocol ID
- 2018SDU-QILU-09
- Status last verified
- Dec 2018
- First submitted
- 4 Dec 2018
- Last updated
- 5 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The 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 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Tailored Bowel Preparation Strategy: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03765216
- Acronym / sponsor ID
- 2018SDU-QILU-09
- Conditions
- Bowel Preparation, Colonoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 28 Feb 2019 (estimated)
- Study completion
- 15 Mar 2019 (estimated)
- First posted
- 5 Dec 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.
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 improve adequate bowel preparation rate by deploying tailored bowel preparation strategy. There are many predictive factors of inadequate bowel preparation such as obesity, constipation, abdominal surgery and so on. By recognizing these risk factors of the patients , we can prescribe the patients with higher dose of bowel cleansing regimen to improve bowel preparation quality.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, 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: 2L Polyethylene Glycol (PEG)Participants are given standard regimen: 2 L Polyethylene Glycol (PEG) regimen. |
| Group B: tailored group | Experimental | Drug: 2L Polyethylene Glycol (PEG), Drug: 4L 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 to 80 years
- 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 |
|---|---|---|
| 2L Polyethylene Glycol (PEG)Also: StandardParticipants 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, Group B: tailored group |
| 4L Polyethylene Glycol (PEG)Also: High doseHigh risk patients in Group B will receive 4 L Polyethylene Glycol (PEG) regimen | Drug | Group B: tailored group |
Primary outcome
Adequate bowel preparation rates
Time frame: 2 months
Adequate bowel preparation rates between 2 groups according to Boston Bowel Preparation Scale (BBPS)
1 secondary outcome
Polyp detection rate
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2018.
- Individual participant dataSharing planned: Undecided. The 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 2L Polyethylene Glycol (PEG) and 4L Polyethylene Glycol (PEG) in people with Bowel Preparation 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: status not confirmed, as of the sponsor's last update on 5 Dec 2018. 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 Li Yanqing, PhD,MD (86-531-82169236, liyanqing@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adequate bowel preparation rates (time frame: 2 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 5 Dec 2018.