Colonoscopy FailurePhase 4NCT01510977
Second Bowel Preparation for Colonoscopy Failure
A Phase 4 study testing polyethylene glycol, Bisacodyl and polyethylene glycol in people with Colonoscopy Failure and Poor Bowel Preparation, run by Asan Medical Center at 1 site in South Korea.
Trial summary
Colonoscopy is a basic but important tool to diagnose and treat lesions of the colon. Proper colon cleansing is essential for colonoscopy to be performed with a good quality. Inadequate bowel preparation leads to longer colonoscopic insertion time and patient discomfort, as well as inadequate diagnostic yield of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy Failure, Poor Bowel Preparation
- What is being tested?
- polyethylene glycol, Bisacodyl and polyethylene glycol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2011to Feb 2013
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- First colonoscopy failure due to inadequate bowel preparation
Who cannot join
- younger than 18 years old
- presence of inflammatory bowel disease
- pregnant
- lactating
- refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Outcome of a Second Preparation for Colonoscopy After Preparation Failure in the First Procedure: a Prospective Randomized Controlled Study
Colonoscopy is a basic but important tool to diagnose and treat lesions of the colon. Proper colon cleansing is essential for colonoscopy to be performed with a good quality. Inadequate bowel preparation leads to longer colonoscopic insertion time and patient discomfort, as well as inadequate diagnostic yield of colonic lesions. Frequency of colonoscopy failure due to bad bowel preparation is reported to be 0.3% to 6.5 percent, and the rate increases with liver cirrhosis, constipation, dementia, stroke, or administration of tricyclic antidepressants. In case of colonoscopy failure due to bad bowel preparation, the second colonoscopy can be performed with either adding a colon cleansing solution immediately, or it can be performed after a few days with colon cleansing agent together with prokinetics. These different kinds of bowel preparations after first colonoscopy failure have not been compared.
- Conditions
- Colonoscopy Failure, Poor Bowel Preparation
- Being tested
- polyethylene glycol, Bisacodyl, polyethylene glycol
- Keywords
- colonoscopy, bowel preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polyethylene glycol, BisacodylDrug
After failure of first colonoscopy, bowel preparation with polyethylene glycol and bisacodyl one week after
polyethylene glycolDrug
Immediately after first colonoscopy failure, polyethylene glycol 2L addition
| Study group | Role | What they receive |
|---|---|---|
| PEG | Active comparator | 2L of polyethylene glycol addition immediately after first colonoscopy failure Receives: Drug: polyethylene glycol |
| PEG + bisacodyl | Experimental | One week after initial colonoscopy failure, conventional amount (5L) of polyethylene glycol together with bisacodyl administration Receives: Drug: polyethylene glycol, Bisacodyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
second colonoscopy failure due to inadequate bowel preparation (PEG+bisdacodyl group)
Measured: one week
second colonoscopy failure due to inadequate bowel preparation (PEG group)
Measured: within the same day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2012 (estimated)
- Study startNov 2011
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonoscopy FailureStudies 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
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeong-Sik Byeon, Asan Medical Center
- Investigators
- Jeong-Sik Byeon, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01510977
- Sponsor's protocol ID
- 2009-0733
- Status last verified
- Feb 2013
- First submitted
- 9 Jan 2012
- Last updated
- 13 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Outcome of a Second Preparation for Colonoscopy After Preparation Failure in the First Procedure: a Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01510977
- Acronym / sponsor ID
- 2009-0733
- Conditions
- Colonoscopy Failure, Poor Bowel Preparation
- Keywords
- colonoscopy, bowel preparation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 18 Jan 2012 (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.
Colonoscopy is a basic but important tool to diagnose and treat lesions of the colon. Proper colon cleansing is essential for colonoscopy to be performed with a good quality. Inadequate bowel preparation leads to longer colonoscopic insertion time and patient discomfort, as well as inadequate diagnostic yield of colonic lesions. Frequency of colonoscopy failure due to bad bowel preparation is reported to be 0.3% to 6.5 percent, and the rate increases with liver cirrhosis, constipation, dementia, stroke, or administration of tricyclic antidepressants. In case of colonoscopy failure due to bad bowel preparation, the second colonoscopy can be performed with either adding a colon cleansing solution immediately, or it can be performed after a few days with colon cleansing agent together with prokinetics. These different kinds of bowel preparations after first colonoscopy failure have not been compared.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEG | Active comparator | Drug: polyethylene glycol2L of polyethylene glycol addition immediately after first colonoscopy failure |
| PEG + bisacodyl | Experimental | Drug: polyethylene glycol, BisacodylOne week after initial colonoscopy failure, conventional amount (5L) of polyethylene glycol together with bisacodyl administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- First colonoscopy failure due to inadequate bowel preparation
Key exclusion criteria (5 listed)
- younger than 18 years old
- presence of inflammatory bowel disease
- pregnant
- lactating
- refusal
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, BisacodylAfter failure of first colonoscopy, bowel preparation with polyethylene glycol and bisacodyl one week after | Drug | PEG + bisacodyl |
| polyethylene glycolImmediately after first colonoscopy failure, polyethylene glycol 2L addition | Drug | PEG |
Primary outcome
second colonoscopy failure due to inadequate bowel preparation (PEG+bisdacodyl group)
Time frame: one week
second colonoscopy failure due to inadequate bowel preparation (PEG group)
Time frame: within the same day
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2013.
Related trials for Colonoscopy Failure
Recruiting
Comparing Three Rescue Bowel Preparation Regimens for Colonoscopy After Failed Cleansing
Bowel Cleansing for Colonoscopy, Inadequate Bowel Preparation
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.
Jeong-Sik Byeon, MD, PhD principal investigator
Asan Medical Center
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 polyethylene glycol, Bisacodyl and polyethylene glycol in people with Colonoscopy Failure and Poor Bowel Preparation, run by Asan Medical Center at 1 site in South Korea.
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 5 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: stopped early, as of the sponsor's last update on 13 Feb 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 South Korea. 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 was stopped early. Results are not available in the source record.
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?
second colonoscopy failure due to inadequate bowel preparation (PEG+bisdacodyl group) (time frame: one week). 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?
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 13 Feb 2013.