Colonoscopy [E01.370.372.250.250.200]NCT01740518
Comparison of Low-volume PEG Plus Ascorbic Acid Versus Standard PEG Solution as Bowel Cleansing for Colonoscopy
An observational study of Colonoscopy [E01.370.372.250.250.200], run by Dong Il Park, M.D, Ph.D. at 1 site in South Korea.
Trial summary
The purpose of this study is to compare two regimens of low volume (2L) polyethylene glycol(PEG)plus ascorbic acid versus standard volume (4L) PEG alone for bowel preparation in out-patients Read more about this study
- Who is it for?
- Ages 19 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy [E01.370.372.250.250.200]
- What is being tested?
- polyethylene glycol, ascorbic acid
- How many people
- 360 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2012to Dec 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 19 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Out-patients for colonoscopy in university hospital
Who may be able to join
- Out-patients for colonoscopy
Who cannot join
- age under 19 years or over 80 years
- Intestinal obstruction
- Women of pregnant, breastfeeding, or at risk of becoming pregnant
- major psychiatric illness
- known allergy to PEG
- serious condition- severe cardiac, renal, or metabolic diseases
Show all 9Show fewer
- past history of colon resection
- current acute exacerbation of chronic inflammatory bowel disease
- functional constipation defined by Rome III diagnostic criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of Low-volume PEG Plus Ascorbic Acid Versus Standard PEG Solution as Bowel Cleansing for Colonoscopy
The purpose of this study is to compare two regimens of low volume (2L) polyethylene glycol(PEG)plus ascorbic acid versus standard volume (4L) PEG alone for bowel preparation in out-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. a new low volume PEG-based bowel cleansing agents became available at foreign countries. Although several studies reported the efficacy and improved compliance of these low volume PEG plus ascorbic acid solution for colonoscopy, but result in Korean patients was not-recognized.
- Conditions
- Colonoscopy [E01.370.372.250.250.200]
- Being tested
- polyethylene glycol, ascorbic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polyethylene glycol, ascorbic acidDrug
comparison of different solutions for bowel preparation
| Study group | Role | What they receive |
|---|---|---|
| PEG + ascorbic acid | Those who taken PEG 2L + ascorbic acid Receives: Drug: polyethylene glycol, ascorbic acid | |
| 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
three segmental preparation scoring (0~4, Rt., mid, Lt.colon) total preparation grade:A,B,C,D (A or B was defined successful bowel cleansing) Influence of the intake of additional fluid in PEG+ascorbic acid
Measured: one day (after colonoscopy)
Secondary outcomes (1)
Patient's compliance and acceptability
satisfaction (Visual Analogue Scale) amount of ingestion, frequency and amount of vomiting, tolerability, complication, taste
Measured: one day (after injestion of preparation solution)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonoscopy [E01.370.372.250.250.200]Studies 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
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dong Il Park, M.D, Ph.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-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
- NCT01740518
- Sponsor's protocol ID
- ASCPD
- Status last verified
- Nov 2012
- First submitted
- 30 Nov 2012
- Last updated
- 4 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Low-volume PEG Plus Ascorbic Acid Versus Standard PEG Solution as Bowel Cleansing for Colonoscopy
- ClinicalTrials.gov ID
- NCT01740518
- Acronym / sponsor ID
- ASCPD
- Conditions
- Colonoscopy [E01.370.372.250.250.200]
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Dong Il Park, M.D, Ph.D.University, hospital or other
- Study start
- Mar 2012
- Primary completion
- Dec 2012 (estimated)
- First posted
- 4 Dec 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 low volume (2L) polyethylene glycol(PEG)plus ascorbic acid versus standard volume (4L) PEG alone for bowel preparation in out-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. a new low volume PEG-based bowel cleansing agents became available at foreign countries. Although several studies reported the efficacy and improved compliance of these low volume PEG plus ascorbic acid solution for colonoscopy, but result in Korean patients was not-recognized.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEG + ascorbic acid | – | Drug: polyethylene glycol, ascorbic acidThose who taken PEG 2L + ascorbic acid |
| PEG 4L | – | –Those who taken PEG 4L alone |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Out-patients for colonoscopy in university hospital
Key inclusion criteria (1 listed)
- Out-patients for colonoscopy
Key exclusion criteria (9 listed)
- age under 19 years or over 80 years
- Intestinal obstruction
- Women of pregnant, breastfeeding, or at risk of becoming pregnant
- major psychiatric illness
- known allergy to PEG
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, ascorbic acidcomparison of different solutions for bowel preparation | Drug | PEG + ascorbic acid |
Primary outcome
The efficacy of bowel preparation
Time frame: one day (after colonoscopy)
three segmental preparation scoring (0~4, Rt., mid, Lt.colon) total preparation grade:A,B,C,D (A or B was defined successful bowel cleansing) Influence of the intake of additional fluid in PEG+ascorbic acid
1 secondary outcome
Patient's compliance and acceptability
Time frame: one day (after injestion of preparation solution)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2012.
- Related InfoLink provided by the sponsor.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colonoscopy [E01.370.372.250.250.200], run by Dong Il Park, M.D, Ph.D. 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 9 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 4 Dec 2012. 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.
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?
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?
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 4 Dec 2012.