The Timing of Bowel Preparation in Outpatient ColonoscopyTOSPNCT01286961
The Interval Between the Time of Second PEG Dose and the Start of the Colonoscopy
An observational study of The Timing of Bowel Preparation in Outpatient Colonoscopy, run by Inje University at 1 site in South Korea.
Trial summary
As the duration of the interval between the time of last preparation-agent dose and the start of the colonoscopy is increasing, the quality of bowel preparation will be worse. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- The Timing of Bowel Preparation in Outpatient Colonoscopy
- What is being tested?
- bowel preparation using split dose of polyethylene glycol
- How many people
- 360 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2011to Sep 2011
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult outpatients who undergo colonoscopy
Who may be able to join
- Adult outpatients(18-85 years of age) who undergo colonoscopy for screening, cancer surveillance or with gastrointestinal symptoms, other symptoms
Who cannot join
- age under 18 years, pregnancy, breast feeding, prior history of surgical large bowel resection, severe renal failure (creatinine ≥ 3.0mg/dL (normal 0.8-1.4)), drug addiction or major psychiatric illness; allergy to PEG, refusal of consent to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
As the duration of the interval between the time of last preparation-agent dose and the start of the colonoscopy is increasing, the quality of bowel preparation will be worse.
Read the detailed description
The aim of the present studies is to determine how the duration of the interval of the time of last preparation dose and the start of colonoscopy affects the quality of the bowel preparation and when the proper timing of the colonoscopy is after completion of last preparation regimen
- Being tested
- bowel preparation using split dose of polyethylene glycol
- Keywords
- Bowel preparation, Polyethylene glycols, Colonoscopy, Outpatient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bowel preparation using split dose of polyethylene glycolDrug
Also called Colyte
polyethylene glycol, split dose(2L/2L), each dose for 1-2hours
| Study group | Role | What they receive |
|---|---|---|
| outpatient colonoscopy, bowel preparation, split dose PEG | adult outpatients who undergo colonoscopy Receives: Drug: bowel preparation using split dose of polyethylene glycol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of bowel preparation according to Ottawa scale
The primary end point of the study was to assess the quality of bowel preparation according to the Ottawa scale, including cleanliness and fluid quantity.
Measured: 6 months
Secondary outcomes (1)
Proper timing of colonoscopy
The secondary end points was to determine the proper interval between the completion of spliting bowel preparation and the start of colonoscopy.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionJul 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Timing of Bowel Preparation in Outpatient 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eun Hee Seo, Inje University
- Investigators
- Tae Oh Kim, Ph.D., Study director, Inje University School of Medicine, Haeundae Paik Hospital, Internal MedicineEun Hee Seo, M.D., Principal investigator, Inje University School of Medicine, Haeundae Paik Hospital, Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01286961
- Sponsor's protocol ID
- HGI 2011-02
- Acronym
- TOSP
- Status last verified
- Oct 2011
- First submitted
- 31 Jan 2011
- Last updated
- 5 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Interval Between the Time of Second PEG Dose and the Start of the Colonoscopy
- ClinicalTrials.gov ID
- NCT01286961
- Acronym / sponsor ID
- TOSP / HGI 2011-02
- Keywords
- Bowel preparation, Polyethylene glycols, Colonoscopy, Outpatient
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 1 Feb 2011 (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.
As the duration of the interval between the time of last preparation-agent dose and the start of the colonoscopy is increasing, the quality of bowel preparation will be worse.
Detailed description
The aim of the present studies is to determine how the duration of the interval of the time of last preparation dose and the start of colonoscopy affects the quality of the bowel preparation and when the proper timing of the colonoscopy is after completion of last preparation regimen
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| outpatient colonoscopy, bowel preparation, split dose PEG | – | Drug: bowel preparation using split dose of polyethylene glycoladult outpatients who undergo colonoscopy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult outpatients who undergo colonoscopy
Key inclusion criteria (1 listed)
- Adult outpatients(18-85 years of age) who undergo colonoscopy for screening, cancer surveillance or with gastrointestinal symptoms, other symptoms
Key exclusion criteria (1 listed)
- age under 18 years, pregnancy, breast feeding, prior history of surgical large bowel resection, severe renal failure (creatinine ≥ 3.0mg/dL (normal 0.8-1.4)), drug addiction or major psychiatric illness; allergy to PEG, refusal of consent to participate in the study.
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 |
|---|---|---|
| bowel preparation using split dose of polyethylene glycolAlso: Colytepolyethylene glycol, split dose(2L/2L), each dose for 1-2hours | Drug | outpatient colonoscopy, bowel preparation, split dose PEG |
Primary outcome
Quality of bowel preparation according to Ottawa scale
Time frame: 6 months
The primary end point of the study was to assess the quality of bowel preparation according to the Ottawa scale, including cleanliness and fluid quantity.
1 secondary outcome
Proper timing of colonoscopy
Time frame: 6 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 5 Oct 2011.
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.
Tae Oh Kim, Ph.D. study director
Inje University School of Medicine, Haeundae Paik Hospital, Internal Medicine
Eun Hee Seo, M.D. principal investigator
Inje University School of Medicine, Haeundae Paik Hospital, Internal Medicine
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 The Timing of Bowel Preparation in Outpatient Colonoscopy, run by Inje University 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 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 Oct 2011. 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?
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 according to Ottawa scale (time frame: 6 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 5 Oct 2011.