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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eun Hee Seo, Inje University
ClinicalTrials.gov Identifier:
NCT01286961
First received: January 31, 2011
Last updated: October 4, 2011
Last verified: October 2011
History of Changes
  Purpose

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 Intervention
The Timing of Bowel Preparation in Outpatient Colonoscopy
 Drug: bowel preparation using split dose of polyethylene glycol

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Interval Between the Time of Second PEG Dose and the Start of the Colonoscopy

Resource links provided by NLM:

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Further study details as provided by Inje University:

Primary Outcome Measures:
  • Quality of bowel preparation according to Ottawa scale [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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:
  • Proper timing of colonoscopy [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    The secondary end points was to determine the proper interval between the completion of spliting bowel preparation and the start of colonoscopy.


Estimated Enrollment: 360
Study Start Date: January 2011
Study Completion Date: September 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Eun Hee Seo, fellow, Inje University
ClinicalTrials.gov Identifier: NCT01286961     History of Changes
Other Study ID Numbers: HGI 2011-02
Study First Received: January 31, 2011
Last Updated: October 4, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Inje University:
Bowel preparation
Polyethylene glycols
Colonoscopy
Outpatient

ClinicalTrials.gov processed this record on June 18, 2013