Effectiveness of Bisacodyl Suppository Agent for Dose Reduction of Low Dose PEG

NCT ID: NCT03849196

Last Updated: 2019-02-21

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

NA

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-31

Study Completion Date

2018-01-30

Brief Summary

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Proper bowel cleansing before colonoscopy is an important factor to increase the detection rate of lesions. Low volume polyethylene glycol (PEG) plus ascorbic (PEG-Asc) has reduced the dosage of previous bowel preparation agent, but it still presents discomfort to patients. The aim of this study was to confirm the efficacy and convenience of volume reduction of PEG-Asc by adding bisacodyl suppository at the same day by compared with conventional 2L PEG-Asc.

Detailed Description

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Eligibility criteria: outpatients between the ages of 20 and 70 years, who were scheduled for colonoscopy between August 2017 and January 2018

Exclusion criteria: patients with a history of gastrointestinal tract surgery, inflammatory bowel disease, severe active colitis, underlying chronic kidney disease, or pregnancy.

Outcome measures: the Boston Bowel Preparation Scale (BBPS)

Conditions

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Bowel Preparation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

prospective, randomized, and observer-blind study
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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2L PEG-Asc

2L PEG-Asc for bowel preparation

Group Type EXPERIMENTAL

2L PEG-Asc

Intervention Type DRUG

PEG-Asc powder

1L PEG-Asc & 'Bisacodyl 10Mg Suppository

1L PEG-Asc with 'Bisacodyl 10Mg Suppository for bowel preparation

Group Type ACTIVE_COMPARATOR

Bisacodyl 10Mg Suppository

Intervention Type DRUG

bisacodyl 10 mg suppository

1L PEG-Asc

Intervention Type DRUG

PEG-Asc powder

Interventions

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2L PEG-Asc

PEG-Asc powder

Intervention Type DRUG

Bisacodyl 10Mg Suppository

bisacodyl 10 mg suppository

Intervention Type DRUG

1L PEG-Asc

PEG-Asc powder

Intervention Type DRUG

Other Intervention Names

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clicool coolprep clicool coolprep

Eligibility Criteria

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Inclusion Criteria

* outpatients who were scheduled for colonoscopy between August 2017 and January 2018

Exclusion Criteria

* History of gastrointestinal tract surgery
* History of inflammatory bowel disease
* History of severe active colitis
* History of chronic kidney disease
* pregnant woman.
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Eun Ran Kim

Clinical associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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[email protected] Kim

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2017-05-100

Identifier Type: -

Identifier Source: org_study_id

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