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

NCT ID: NCT01740518

Last Updated: 2012-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

360 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Colonoscopy [E01.370.372.250.250.200]

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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PEG + ascorbic acid

Those who taken PEG 2L + ascorbic acid

polyethylene glycol, ascorbic acid

Intervention Type DRUG

comparison of different solutions for bowel preparation

PEG 4L

Those who taken PEG 4L alone

No interventions assigned to this group

Interventions

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polyethylene glycol, ascorbic acid

comparison of different solutions for bowel preparation

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dong Il Park, M.D, Ph.D.

OTHER

Sponsor Role lead

Responsible Party

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Dong Il Park, M.D, Ph.D.

associate professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Dong Il Park, professor

Role: PRINCIPAL_INVESTIGATOR

Kangbuk Samsung Hospital

Locations

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Kangbuk Samsung Hospital

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

Related Links

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http://irb.kbsmc.co.kr

Related Info

Other Identifiers

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ASCPD

Identifier Type: -

Identifier Source: org_study_id