The Comparative Study Between Bowel Preparation Method

NCT ID: NCT01964417

Last Updated: 2014-01-13

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

319 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-01-31

Brief Summary

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The purpose of this study is to compare the efficacy, acceptability and preparation-induced mucosal inflammation of PEG + ascorbic acid vs. PEG for colonoscopy.

Detailed Description

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This was a prospective randomized single-blinded clinical trial of ambulatory patients to assess the efficacy of bowel preparation and preparation-induced mucosal inflammation.

Endoscopists who were blinded to the preparation taken, assessed both bowel cleansing by using the Ottawa bowel preparation assessment tool and preparation-induced mucosal inflammation. Acceptability was assessed by questionnaire.

Conditions

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Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Investigators

Study Groups

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4L-split Dose of PEG Solution

4L-split Dose of PEG Solution for bowel preparation

Group Type ACTIVE_COMPARATOR

Colonoscopy after bowel cleansing

Intervention Type DRUG

Low-volume PEG Plus Ascorbic Acid

Low-volume PEG Plus Ascorbic Acid for bowel preparation

Group Type ACTIVE_COMPARATOR

Colonoscopy after bowel cleansing

Intervention Type DRUG

Interventions

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Colonoscopy after bowel cleansing

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients who want colonoscopy purposing screening among adults between the age of 20\~65

Exclusion Criteria

* Under the age of 20, older than 65, pregnant or lactating women, intestinal obstruction, structural intestinal disease, hypothyroidism, gastrointestinal motility, renal failure, congestive heart failure, liver failure, electrolyte abnormalities, who refused research informed consent, inflammatory bowel disease, the obvious symptoms of the disease in patients with lower gastrointestinal (bloody stools, diarrhea, etc.)
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Inje University

OTHER

Sponsor Role lead

Responsible Party

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Jongha Park

Inje University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jongha Park, MD

Role: PRINCIPAL_INVESTIGATOR

Inje University

Locations

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Haeundae Paik Hospital

Busan, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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PEG-0488

Identifier Type: -

Identifier Source: org_study_id

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