Bowel Cleansing QualityPhase 4NCT02415569
Tailored Bowel Preparation According to Bristol Stool Form Scale
A Phase 4 study testing Standard Bowel Prep (2L PEG-ELP) and 2L PEG-ELP and 10mg bisacodyl in people with Bowel Cleansing Quality, run by Shandong University at 1 site in China.
Trial summary
The Bristol stool form scale ( BSFS) based tailored bowel cleansing regimen might be helpful to improve bowel cleansing quality before colonoscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bowel Cleansing Quality
- What is being tested?
- Standard Bowel Prep (2L PEG-ELP) and 2L PEG-ELP and 10mg bisacodyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to Oct 2015
- Phase
- Phase 4
- 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 18 years of age or older,
- scheduled to undergo elective outpatient colonoscopy,
- and were able to provide informed consent.
Who cannot join
- history of colorectal surgery
- severe colonic stricture or obstructing tumour
- dysphagia
- compromised swallowing reflex or mental status
- significant gastroparesis or gastric outlet obstruction
- known or suspected bowel obstruction or perforation
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- 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)
- inflammatory bowel disease or megacolon
- dehydration
- disturbance of electrolytes
- pregnancy or lactation
- haemodynamically unstable
- unable to give informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, 250012
About this study
Official title: Tailored Bowel Preparation According to Bristol Stool Form Scale: a Prospective, Randomized, Controlled, Investigator-blinded, Multicenter Study
The Bristol stool form scale ( BSFS) based tailored bowel cleansing regimen might be helpful to improve bowel cleansing quality before colonoscopy.
Read the detailed description
Colonoscopy is the standard approach for evaluating the colon currently. Thorough bowel cleansing is critical for adequate visualization of colonic mucosa during colonoscopy. Inadequate bowel cleansing results in adverse consequences for the examination, including lower adenoma detection rates, longer procedural time, lower cecal intubation rates, shorter intervals between examinations and an estimated 12-22% increase in overall colonoscopy cost.Unfortunately, despite advances in bowel preparation methods, up to one-third of all colonoscopies are reported to have an inadequate bowel preparation.
The Bristol stool form scale ( BSFS) was developed in 1988 by O'Donnell LJD et al and was widely applied in both gastrointestinal study and clinical practice. BSFS divides human stool into 7 different styles according to its moisture content. In our clinical work, we find that it is prone to gain poor bowel cleansing quality in patients who pass type 1or 2 stool. Unfortunately, there is lacking of study on tailored bowel preparation according to Bristol stool form scale. Thus, we intend to develop an easy, practical, BSFS based tailored bowel cleansing regimen, in order to serve clinical work and research.
- Conditions
- Bowel Cleansing Quality
- Being tested
- Standard Bowel Prep (2L PEG-ELP), 2L PEG-ELP and 10mg bisacodyl
- Keywords
- bowel cleansing, bisacodyl, polyethyleneglycol, colonoscopy, the bristol stool form scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Bowel Prep (2L PEG-ELP)Drug
Subjects whose bristol stool forms are type 1 or 2, will be asked to take standard bowel prep (2L PEG-ELP) the same-day of procedure.
2L PEG-ELP and 10mg bisacodylDrug
Subjects whose bristol stool forms are type 1 or 2, will be asked to take standard bowel prep (2L PEG-ELP) the same-day of procedure and 10mg bisacodyl the day before procedure.
Standard Bowel Prep (2L PEG-ELP)Drug
Subjects whose bristol stool forms are type 3 to 7, will be asked to take standard bowel prep (2L PEG-ELP) the same-day of procedure.
| Study group | Role | What they receive |
|---|---|---|
| group1 | Experimental | Subjects whose bristol stool forms are type 1 or 2, will receive standard bowel prep (2L PEG-ELP) the same-day of procedure. Receives: Drug: Standard Bowel Prep (2L PEG-ELP) |
| group2 | Experimental | Subjects whose bristol stool forms are type 1 or 2, will be asked to take standard bowel prep (2L PEG-ELP) the same-day of procedure and 10mg bisacodyl the day before procedure. ( 2L PEG-ELP and 10mg bisacodyl ) Receives: Drug: 2L PEG-ELP and 10mg bisacodyl |
| group3 | Active comparator | Subjects whose bristol stool forms are type 3 to 7, will receive standard bowel prep (2L PEG-ELP) the same-day of procedure. Receives: Drug: Standard Bowel Prep (2L PEG-ELP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of scores rating by Boston Bowel Preparation Scale among 3 groups.
This is an established rating scale to evaluate the quality of bowel prep. The ratings will be compared among the 3 groups.
Measured: 9 months
Secondary outcomes (5)
Rate of non-compliance with instructions among 3 groups.
Measured: 9 months
Willingness to repeat bowel preparation among 3 groups.
Measured: 9 months
Polyp detection rate among 3 groups.
Measured: 9 months
Caecal intubation rate among 3 groups.
Measured: 9 months
Withdrawal time among 3 groups.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2015 (estimated)
- Study startJan 2015
- Primary completionOct 2015
- Study completionOct 2015
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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Qianfoshan Hospital, Binzhou People's Hospital
- 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
- NCT02415569
- Sponsor's protocol ID
- 2014SDU-QILU-G07
- Status last verified
- Apr 2016
- First submitted
- 21 Jan 2015
- Last updated
- 2 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored Bowel Preparation According to Bristol Stool Form Scale: a Prospective, Randomized, Controlled, Investigator-blinded, Multicenter Study
- ClinicalTrials.gov ID
- NCT02415569
- Acronym / sponsor ID
- 2014SDU-QILU-G07
- Conditions
- Bowel Cleansing Quality
- Keywords
- bowel cleansing, bisacodyl, polyethyleneglycol, colonoscopy, the bristol stool form scale
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Collaborators
- Qianfoshan Hospital, Binzhou People's Hospital
- Study start
- Jan 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 14 Apr 2015 (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.
The Bristol stool form scale ( BSFS) based tailored bowel cleansing regimen might be helpful to improve bowel cleansing quality before colonoscopy.
Detailed description
Colonoscopy is the standard approach for evaluating the colon currently. Thorough bowel cleansing is critical for adequate visualization of colonic mucosa during colonoscopy. Inadequate bowel cleansing results in adverse consequences for the examination, including lower adenoma detection rates, longer procedural time, lower cecal intubation rates, shorter intervals between examinations and an estimated 12-22% increase in overall colonoscopy cost.Unfortunately, despite advances in bowel preparation methods, up to one-third of all colonoscopies are reported to have an inadequate bowel preparation.
The Bristol stool form scale ( BSFS) was developed in 1988 by O'Donnell LJD et al and was widely applied in both gastrointestinal study and clinical practice. BSFS divides human stool into 7 different styles according to its moisture content. In our clinical work, we find that it is prone to gain poor bowel cleansing quality in patients who pass type 1or 2 stool. Unfortunately, there is lacking of study on tailored bowel preparation according to Bristol stool form scale. Thus, we intend to develop an easy, practical, BSFS based tailored bowel cleansing regimen, in order to serve clinical work and research.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group1 | Experimental | Drug: Standard Bowel Prep (2L PEG-ELP)Subjects whose bristol stool forms are type 1 or 2, will receive standard bowel prep (2L PEG-ELP) the same-day of procedure. |
| group2 | Experimental | Drug: 2L PEG-ELP and 10mg bisacodylSubjects whose bristol stool forms are type 1 or 2, will be asked to take standard bowel prep (2L PEG-ELP) the same-day of procedure and 10mg bisacodyl the day before procedure. ( 2L PEG-ELP and 10mg bisacodyl ) |
| group3 | Active comparator | Drug: Standard Bowel Prep (2L PEG-ELP)Subjects whose bristol stool forms are type 3 to 7, will receive standard bowel prep (2L PEG-ELP) the same-day of procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients 18 years of age or older,
- scheduled to undergo elective outpatient colonoscopy,
- and were able to provide informed consent.
Key exclusion criteria (15 listed)
- history of colorectal surgery
- severe colonic stricture or obstructing tumour
- dysphagia
- compromised swallowing reflex or mental status
- 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 |
|---|---|---|
| Standard Bowel Prep (2L PEG-ELP)Subjects whose bristol stool forms are type 1 or 2, will be asked to take standard bowel prep (2L PEG-ELP) the same-day of procedure. | Drug | group1 |
| 2L PEG-ELP and 10mg bisacodylSubjects whose bristol stool forms are type 1 or 2, will be asked to take standard bowel prep (2L PEG-ELP) the same-day of procedure and 10mg bisacodyl the day before procedure. | Drug | group2 |
| Standard Bowel Prep (2L PEG-ELP)Subjects whose bristol stool forms are type 3 to 7, will be asked to take standard bowel prep (2L PEG-ELP) the same-day of procedure. | Drug | group3 |
Primary outcome
Difference of scores rating by Boston Bowel Preparation Scale among 3 groups.
Time frame: 9 months
This is an established rating scale to evaluate the quality of bowel prep. The ratings will be compared among the 3 groups.
5 secondary outcomes
Rate of non-compliance with instructions among 3 groups.
Time frame: 9 months
Willingness to repeat bowel preparation among 3 groups.
Time frame: 9 months
Polyp detection rate among 3 groups.
Time frame: 9 months
Caecal intubation rate among 3 groups.
Time frame: 9 months
Withdrawal time among 3 groups.
Time frame: 9 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 2 May 2016.
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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 Phase 4 study testing Standard Bowel Prep (2L PEG-ELP) and 2L PEG-ELP and 10mg bisacodyl in people with Bowel Cleansing Quality, 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 3 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 2 May 2016. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Difference of scores rating by Boston Bowel Preparation Scale among 3 groups. (time frame: 9 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 2 May 2016.