Intestine; ComplaintsPEGNCT01528098
Comparison of Bowel Cleansing Methods for Colonoscopy in Hospitalized Patients
An observational study of Intestine; Complaints, run by Kangbuk Samsung Hospital.
Trial summary
The purpose of this study is to compare two regimens of polyethylene glycol(PEG) plus bisacodyl versus PEG alone for bowel preparation in hospitalized patients. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Intestine; Complaints
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to Oct 2012
- Phase
- Observational
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Hospitalized patients for colonoscopy in university hospital.
Who may be able to join
- Hospitalized patients for colonoscopy
Who cannot join
- age under 20 years or over 80 years
- major psychiatric illness
- known allergy to PEG
- serious condition- severe cardiac, renal, or metabolic diseases
- partial colon resection
- current acute exacerbation of chronic inflammatory bowel disease
- functional constipation defined by Rome III diagnostic criteria
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy of Bisacodyl Given as Part of a Polyethylene Glycol-based Bowel Preparation Prior to Colonoscopy in Hospitalized Patients
The purpose of this study is to compare two regimens of polyethylene glycol(PEG) plus bisacodyl versus PEG alone for bowel preparation in hospitalized patients.
Read the detailed description
Inadequate bowel preparation may lead to a longer colonoscopy, and to an inability to identify lesions. PEG can provide a rapid orthograde peroral approach to colonic lavage without producing significant fluid or electrolyte changes. Thus PEG is now commonly used for bowel preparation. However, large amounts and unsatisfactory taste of PEG solution are generally poorly tolerated, especially in hospitalized patients who had comorbidity and restricted ambulation. Recently, a new PEG-based bowel cleansing agents became available. It combines PEG with a high dose of ascorbic acid or bisacodyl. Although many studies reported the efficacy of these combined solution for colonoscopy, but efficacy in hospitalized patients was under-recognized.
- Conditions
- Intestine; Complaints
- Keywords
- polyethylene glycol, bisacodyl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PEG plus bisacodyl | Those who taken PEG 4L + bisacodyl 10mg | |
| PEG 4L | Those who taken PEG 4L alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy of bowel preparation
Ottawa scale
Measured: one day (after colonoscopy)
Secondary outcomes (3)
Patient's compliance and acceptability
acceptability, Visual Analogue Scale
Measured: one day (after injestion of preparation solution)
Patient's compliance and acceptability (2)
stress for ingestion, Stress 0(not) - 4(severe)
Measured: one day (after injestion of preparation solution)
Patient's compliance and acceptability (3)
willingness for re-evaluation, 0(very willing) - 4(some)
Measured: one day (after colonoscopy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionJul 2012 (estimated)
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestine; ComplaintsStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kangbuk Samsung Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Soon Chun Hyang University, Kyunghee University, Hanyang University
- Responsible party
- Principal investigator, Dong Il Park, M.D, Ph.D., Kangbuk Samsung Hospital
- Investigators
- Dong Il Park, Professor, Principal investigator, Kangbuk Samsung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01528098
- Sponsor's protocol ID
- PEGPD
- Acronym
- PEG
- Status last verified
- Feb 2012
- First submitted
- 3 Feb 2012
- Last updated
- 22 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Bisacodyl Given as Part of a Polyethylene Glycol-based Bowel Preparation Prior to Colonoscopy in Hospitalized Patients
- ClinicalTrials.gov ID
- NCT01528098
- Acronym / sponsor ID
- PEG / PEGPD
- Conditions
- Intestine; Complaints
- Keywords
- polyethylene glycol, bisacodyl
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Kangbuk Samsung HospitalUniversity, hospital or other
- Collaborators
- Soon Chun Hyang University, Kyunghee University, Hanyang University
- Study start
- Mar 2012
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 7 Feb 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.
The purpose of this study is to compare two regimens of polyethylene glycol(PEG) plus bisacodyl versus PEG alone for bowel preparation in hospitalized patients.
Detailed description
Inadequate bowel preparation may lead to a longer colonoscopy, and to an inability to identify lesions. PEG can provide a rapid orthograde peroral approach to colonic lavage without producing significant fluid or electrolyte changes. Thus PEG is now commonly used for bowel preparation. However, large amounts and unsatisfactory taste of PEG solution are generally poorly tolerated, especially in hospitalized patients who had comorbidity and restricted ambulation. Recently, a new PEG-based bowel cleansing agents became available. It combines PEG with a high dose of ascorbic acid or bisacodyl. Although many studies reported the efficacy of these combined solution for colonoscopy, but efficacy in hospitalized patients was under-recognized.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEG plus bisacodyl | – | –Those who taken PEG 4L + bisacodyl 10mg |
| PEG 4L | – | –Those who taken PEG 4L alone |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients for colonoscopy in university hospital.
Key inclusion criteria (1 listed)
- Hospitalized patients for colonoscopy
Key exclusion criteria (7 listed)
- age under 20 years or over 80 years
- major psychiatric illness
- known allergy to PEG
- serious condition- severe cardiac, renal, or metabolic diseases
- partial colon resection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The efficacy of bowel preparation
Time frame: one day (after colonoscopy)
Ottawa scale
3 secondary outcomes
Patient's compliance and acceptability
Time frame: one day (after injestion of preparation solution)
Patient's compliance and acceptability (2)
Time frame: one day (after injestion of preparation solution)
Patient's compliance and acceptability (3)
Time frame: one day (after colonoscopy)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2012.
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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.
Dong Il Park, Professor principal investigator
Kangbuk Samsung Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Intestine; Complaints, run by Kangbuk Samsung Hospital.
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 7 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 22 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
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 Dong Il Park, professor (82-2-2001-2059, diksmc.park@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The efficacy of bowel preparation (time frame: one day (after colonoscopy)). 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 22 Feb 2012.