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Comparison of Low-volume PEG Plus Ascorbic Acid Versus Standard PEG Solution as Bowel Cleansing for Colonoscopy

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ClinicalTrials.gov Identifier: NCT01740518
Recruitment Status : Unknown
Verified November 2012 by Dong Il Park, M.D, Ph.D., Kangbuk Samsung Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : December 4, 2012
Last Update Posted : December 4, 2012
Sponsor:
Information provided by (Responsible Party):
Dong Il Park, M.D, Ph.D., Kangbuk Samsung Hospital

Brief 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

Condition or disease Intervention/treatment
Colonoscopy [E01.370.372.250.250.200] Drug: polyethylene glycol, ascorbic acid

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.

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Study Type : Observational
Estimated Enrollment : 360 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Randomized Controlled Trial of Low-volume PEG Plus Ascorbic Acid Versus Standard PEG Solution as Bowel Cleansing for Colonoscopy
Study Start Date : March 2012
Estimated Primary Completion Date : December 2012

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
PEG + ascorbic acid
Those who taken PEG 2L + ascorbic acid
Drug: polyethylene glycol, ascorbic acid
comparison of different solutions for bowel preparation

PEG 4L
Those who taken PEG 4L alone



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Patient's compliance and acceptability [ Time Frame: one day (after injestion of preparation solution) ]
    satisfaction (Visual Analogue Scale) amount of ingestion, frequency and amount of vomiting, tolerability, complication, taste



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Out-patients for colonoscopy in university hospital
Criteria

Inclusion Criteria:

  • Out-patients for colonoscopy

Exclusion Criteria:

  • 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
  • past history of colon resection
  • current acute exacerbation of chronic inflammatory bowel disease
  • functional constipation defined by Rome III diagnostic criteria

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): NCT01740518


Locations
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Korea, Republic of
Kangbuk Samsung Hospital
Seoul, Korea, Republic of, 110-746
Sponsors and Collaborators
Dong Il Park, M.D, Ph.D.
Investigators
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Principal Investigator: Dong Il Park, professor Kangbuk Samsung Hospital
Additional Information:
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Responsible Party: Dong Il Park, M.D, Ph.D., associate professor, Kangbuk Samsung Hospital
ClinicalTrials.gov Identifier: NCT01740518    
Other Study ID Numbers: ASCPD
First Posted: December 4, 2012    Key Record Dates
Last Update Posted: December 4, 2012
Last Verified: November 2012
Additional relevant MeSH terms:
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Ascorbic Acid
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Nutrients
Growth Substances