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The Interval Between the Time of Second PEG Dose and the Start of the Colonoscopy (TOSP)

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ClinicalTrials.gov Identifier: NCT01286961
Recruitment Status : Completed
First Posted : February 1, 2011
Last Update Posted : October 5, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
The Timing of Bowel Preparation in Outpatient Colonoscopy Drug: bowel preparation using split dose of polyethylene glycol

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

Study Type : Observational
Estimated Enrollment : 360 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Interval Between the Time of Second PEG Dose and the Start of the Colonoscopy
Study Start Date : January 2011
Primary Completion Date : July 2011
Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
outpatient colonoscopy, bowel preparation, split dose PEG
adult outpatients who undergo colonoscopy
Drug: bowel preparation using split dose of polyethylene glycol
polyethylene glycol, split dose(2L/2L), each dose for 1-2hours
Other Name: Colyte


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult outpatients who undergo colonoscopy
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01286961


Locations
Korea, Republic of
Haeundae Paik Hospital
Busan, Korea, Republic of, 612-030
Sponsors and Collaborators
Inje University
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
More Information

Responsible Party: Eun Hee Seo, fellow, Inje University
ClinicalTrials.gov Identifier: NCT01286961     History of Changes
Other Study ID Numbers: HGI 2011-02
First Posted: February 1, 2011    Key Record Dates
Last Update Posted: October 5, 2011
Last Verified: October 2011

Keywords provided by Eun Hee Seo, Inje University:
Bowel preparation
Polyethylene glycols
Colonoscopy
Outpatient