- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01286961
The Interval Between the Time of Second PEG Dose and the Start of the Colonoscopy (TOSP)
October 4, 2011 updated by: Eun Hee Seo, Inje University
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
360
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Busan, Korea, Republic of, 612-030
- Haeundae Paik Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adult outpatients who undergo colonoscopy
Description
Inclusion Criteria:
- Adult outpatients(18-85 years of age) who undergo colonoscopy for screening, cancer surveillance or with gastrointestinal symptoms, other symptoms
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
outpatient colonoscopy, bowel preparation, split dose PEG
adult outpatients who undergo colonoscopy
|
polyethylene glycol, split dose(2L/2L), each dose for 1-2hours
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proper timing of colonoscopy
Time Frame: 6 months
|
The secondary end points was to determine the proper interval between the completion of spliting bowel preparation and the start of colonoscopy.
|
6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Tae Oh Kim, Ph.D., Inje University School of Medicine, Haeundae Paik Hospital, Internal Medicine
- Principal Investigator: Eun Hee Seo, M.D., Inje University School of Medicine, Haeundae Paik Hospital, Internal Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (Actual)
July 1, 2011
Study Completion (Actual)
September 1, 2011
Study Registration Dates
First Submitted
January 31, 2011
First Submitted That Met QC Criteria
January 31, 2011
First Posted (Estimate)
February 1, 2011
Study Record Updates
Last Update Posted (Estimate)
October 5, 2011
Last Update Submitted That Met QC Criteria
October 4, 2011
Last Verified
October 1, 2011
More Information
Terms related to this study
Other Study ID Numbers
- HGI 2011-02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on bowel preparation using split dose of polyethylene glycol
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The Cleveland ClinicCompleted
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Braintree LaboratoriesCompleted
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Cook County HealthCompletedBowel Preparation for ColonoscopyUnited States
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Braintree LaboratoriesCompletedColon CancerUnited States
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Braintree LaboratoriesCompletedBLI-800-301: BLI-800 vs an Active Control Bowel Preparation in Adult Subjects Undergoing ColonoscopyColonoscopyUnited States
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Braintree LaboratoriesCompletedColon CancerUnited States
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Braintree LaboratoriesCompletedColonoscopyUnited States
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Braintree LaboratoriesCompletedBLI-800-302: BLI-800 vs an Active Control Bowel Preparation in Adult Subjects Undergoing ColonoscopyColonoscopyUnited States