Bowel Preparation for Morning ColonoscopyNCT01916564
Split-dose Versus Same-day Reduced-volume PEG-ELS Plus Bisacodyl for Morning Colonoscopy
A study testing Split-dose and Same-morning whole-dose in people with Bowel Preparation for Morning Colonoscopy, run by University of Malaya at 1 site in Malaysia.
Trial summary
This study aims to compare split-dose vs. same-morning whole-dose of 2-litre PEG-ELS plus bisacodyl for bowel preparation for morning outpatient colonoscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bowel Preparation for Morning Colonoscopy
- What is being tested?
- Split-dose and Same-morning whole-dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 303 participants
- Where
- 1 siteMalaysia
- Study dates
- Aug 2012to Mar 2013
- 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
- Consecutive adult patients undergoing morning outpatient colonoscopy at the Endoscopy Unit, University of Malaya Medical Centre
Who cannot join
- In-patients, patients scheduled for afternoon colonoscopy, patients who used other bowel preparation regime than that assigned, patients who had incomplete examination not related o quality of bowel preparation e.g. obstructing tumour
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Endoscocpy Unit, University of Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, 59100
About this study
Official title: Efficacy and Tolerability of Split-dose Versus Same-day Administration of Reduced-volume PEG-ELS Plus Bisacodyl for Morning Colonoscopy: a Randomised Trial
This study aims to compare split-dose vs. same-morning whole-dose of 2-litre PEG-ELS plus bisacodyl for bowel preparation for morning outpatient colonoscopy.
Read the detailed description
A good bowel preparation regime is one that is not only effective in cleansing the colon but should be relatively small in volume and well-tolerated by patients with minimal adverse gastrointestinal symptoms. At our centre, reduced-volume 2-litre PEG-ELS plus bisacodyl and low fiber diet is used for bowel preparation for patients undergoing colonoscopy. Patients undergoing morning outpatient colonoscopy would normally ingest the PEG-ELS and bisacodyl the day before. This regime has been shown to be better tolerated by patients without compromising the quality of bowel preparation when compared with conventional 4-liter PEG-ELS. However, previous study on patient satisfaction found that nearly half of the patients attending the outpatient colonoscopy service at our centre were dissatisfied with the bowel preparation regime used. Of the seven items considered in the evaluation of patient satisfaction, comfort level during bowel preparation was the main cause of unfavorable responses. Moreover, a separate study using the same bowel preparation regime at our centre found a high percentage of poor quality bowel preparation, which was associated with increased technical difficulty and patient discomfort during colonoscopy. There was clearly a need for a better bowel preparation regime. Current literature suggests that either taking reduced-volume PEG-ELS on the same morning instead of the previous evening, or splitting the bowel preparation, would be better. However, whether the former or the latter is better, is unknown. The aim of our study was to compare the use of same-morning whole-dose reduced-volume PEG-ELS and split-dose reduced-volume PEG-ELS for bowel preparation for patients undergoing morning outpatient colonoscopy.
- Being tested
- Split-dose, Same-morning whole-dose
- Keywords
- Bowel preparation, Morning colonoscopy, Split-dose, Same-morning whole-dose, Reduced-volume PEG-ELS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Split-doseOther
2 tablets of bisacodyl 5 mg at 8 p.m. two days before colonoscopy
Low fibre diet and 2 tablets of bisacodyl 5 mg at 8 p.m. on the day before colonoscopy
1-L PEG-ELS between 8 p.m. and 8.30 p.m. on the day before and 1-L PEG-ELS between 5.30 a.m. and 6 a.m. on the day of colonoscopy
Same-morning whole-doseOther
2 tablets of bisacodyl 5 mg at 8 p.m. two days before colonoscopy
Low fibre diet and 2 tablets of bisacodyl 5 mg at 8 p.m. on the day before colonoscopy
2-L PEG-ELS between 5 a.m. and 6 a.m. on the day of colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| Same-morning whole-dose | Active comparator | 2-L PEG-ELS between 5 a.m. and 6 a.m. on the day of colonoscopy Receives: Other: Same-morning whole-dose |
| Split-dose | Active comparator | 1-L PEG-ELS between 8 p.m. and 8.30 p.m. on the day before and 1-L PEG-ELS between 5.30 a.m. and 6 a.m. on the day of colonoscopy Receives: Other: Split-dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of bowel preparation
Using the Boston Bowel Preparation Scale and an overall grading by the endoscopist
Measured: During the colonoscopy procedure itself which spans an average of 20 minutes
Patient tolerability
Using the questionnaire by Aronchick and colleagues and an ordinal five-value Likert scale question on comfort level during bowel preparation
Measured: The period from commencement of bowel preparation to the colonoscopy procedure itself which spans approximately 36 hours
Secondary outcomes (1)
Technical aspects of colonoscopy
Cecal intubation rate, cecal intubation, withdrawal and colonoscopy times, adenoma detection rate and number of adenoma detected are recorded
Measured: During the colonoscopy procedure itself which spans an average of 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2013 (estimated)
- Study startAug 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bowel Preparation for Morning ColonoscopyStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chan Wah Kheong, University of Malaya
- Investigators
- Wah Kheong Chan, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01916564
- Sponsor's protocol ID
- SplitAMBPrep
- Status last verified
- Aug 2013
- First submitted
- 26 Jul 2013
- Last updated
- 5 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Chan WK, Azmi N, Mahadeva S, Goh KL. Split-dose vs same-day reduced-volume polyethylene glycol electrolyte lavage solution for morning colonoscopy. World J Gastroenterol. 2014 Oct 21;20(39):14488-94. doi: 10.3748/wjg.v20.i39.14488.
PubMed 25339836
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerability of Split-dose Versus Same-day Administration of Reduced-volume PEG-ELS Plus Bisacodyl for Morning Colonoscopy: a Randomised Trial
- ClinicalTrials.gov ID
- NCT01916564
- Acronym / sponsor ID
- SplitAMBPrep
- Keywords
- Bowel preparation, Morning colonoscopy, Split-dose, Same-morning whole-dose, Reduced-volume PEG-ELS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 5 Aug 2013 (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.
This study aims to compare split-dose vs. same-morning whole-dose of 2-litre PEG-ELS plus bisacodyl for bowel preparation for morning outpatient colonoscopy.
Detailed description
A good bowel preparation regime is one that is not only effective in cleansing the colon but should be relatively small in volume and well-tolerated by patients with minimal adverse gastrointestinal symptoms. At our centre, reduced-volume 2-litre PEG-ELS plus bisacodyl and low fiber diet is used for bowel preparation for patients undergoing colonoscopy. Patients undergoing morning outpatient colonoscopy would normally ingest the PEG-ELS and bisacodyl the day before. This regime has been shown to be better tolerated by patients without compromising the quality of bowel preparation when compared with conventional 4-liter PEG-ELS. However, previous study on patient satisfaction found that nearly half of the patients attending the outpatient colonoscopy service at our centre were dissatisfied with the bowel preparation regime used. Of the seven items considered in the evaluation of patient satisfaction, comfort level during bowel preparation was the main cause of unfavorable responses. Moreover, a separate study using the same bowel preparation regime at our centre found a high percentage of poor quality bowel preparation, which was associated with increased technical difficulty and patient discomfort during colonoscopy. There was clearly a need for a better bowel preparation regime. Current literature suggests that either taking reduced-volume PEG-ELS on the same morning instead of the previous evening, or splitting the bowel preparation, would be better. However, whether the former or the latter is better, is unknown. The aim of our study was to compare the use of same-morning whole-dose reduced-volume PEG-ELS and split-dose reduced-volume PEG-ELS for bowel preparation for patients undergoing morning outpatient colonoscopy.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Same-morning whole-dose | Active comparator | Other: Same-morning whole-dose2-L PEG-ELS between 5 a.m. and 6 a.m. on the day of colonoscopy |
| Split-dose | Active comparator | Other: Split-dose1-L PEG-ELS between 8 p.m. and 8.30 p.m. on the day before and 1-L PEG-ELS between 5.30 a.m. and 6 a.m. on the day of colonoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consecutive adult patients undergoing morning outpatient colonoscopy at the Endoscopy Unit, University of Malaya Medical Centre
Key exclusion criteria (1 listed)
- In-patients, patients scheduled for afternoon colonoscopy, patients who used other bowel preparation regime than that assigned, patients who had incomplete examination not related o quality of bowel preparation e.g. obstructing tumour
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 |
|---|---|---|
| Split-dose2 tablets of bisacodyl 5 mg at 8 p.m. two days before colonoscopy Low fibre diet and 2 tablets of bisacodyl 5 mg at 8 p.m. on the day before colonoscopy 1-L PEG-ELS between 8 p.m. and 8.30 p.m. on the day before and 1-L PEG-ELS between 5.30 a.m. and 6 a.m. on the day of colonoscopy | Other | Split-dose |
| Same-morning whole-dose2 tablets of bisacodyl 5 mg at 8 p.m. two days before colonoscopy Low fibre diet and 2 tablets of bisacodyl 5 mg at 8 p.m. on the day before colonoscopy 2-L PEG-ELS between 5 a.m. and 6 a.m. on the day of colonoscopy | Other | Same-morning whole-dose |
Primary outcome
Quality of bowel preparation
Time frame: During the colonoscopy procedure itself which spans an average of 20 minutes
Using the Boston Bowel Preparation Scale and an overall grading by the endoscopist
Patient tolerability
Time frame: The period from commencement of bowel preparation to the colonoscopy procedure itself which spans approximately 36 hours
Using the questionnaire by Aronchick and colleagues and an ordinal five-value Likert scale question on comfort level during bowel preparation
1 secondary outcome
Technical aspects of colonoscopy
Time frame: During the colonoscopy procedure itself which spans an average of 20 minutes
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 5 Aug 2013.
- Derived from this study: PubMed 25339836Chan WK, Azmi N, Mahadeva S, Goh KL. Split-dose vs same-day reduced-volume polyethylene glycol electrolyte lavage solution for morning colonoscopy. World J Gastroenterol. 2014 Oct 21;20(39):14488-94. doi: 10.3748/wjg.v20.i39.14488.
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.
Wah Kheong Chan principal investigator
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Split-dose and Same-morning whole-dose in people with Bowel Preparation for Morning Colonoscopy, run by University of Malaya at 1 site in Malaysia.
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 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 5 Aug 2013. 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 Malaysia. 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: During the colonoscopy procedure itself which spans an average of 20 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01916564, which also lists 1 linked publication.
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 Aug 2013.