Low Volume PEG With Low Residue Test Meals Versus High Volume Split-dose PEG Bowel Preparation

NCT ID: NCT01568814

Last Updated: 2012-04-03

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

188 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-03-31

Brief Summary

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Morning only low volume PEG with low reside meals may enhance patient tolerability and have similar bowel cleansing efficacy compared to standard method using high volume split-dose PEG with standard diet.

Detailed Description

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We aimed to evaluate the efficacy and tolerability of bowel preparation protocols with low volume PEG and low residue meals PEG compared to conventional high volume (4L) split-dose and standard diet.

Entry criteria: Entry criteria: Adult outpatients and inpatients (18-85 years of age) who undergo colonoscopy for screening, cancer surveillance or with gastrointestinal symptoms, other symptoms

Primary Outcome: Quality of bowel preparation (Ottawa scale) Secondary Outcome: Tolerability (preparation completion, side effect), acceptance, willingness

Conditions

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Bowel Preparation Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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High volume PEG

Patients who are scheduled colonoscopy ingest high volume PEG(4L) for bowel preparation.

Group Type PLACEBO_COMPARATOR

high volume PEG

Intervention Type DRUG

high volume polyethylene glycol 4 lilter split-dosing 2L/2L two times

Low volume PEG with low residual meals

Patients who are scheduled colonoscopy ingest low volume PEG(2L) and have a prepackaged low residual meals for bowel preparation.

Group Type ACTIVE_COMPARATOR

Low volume PEG

Intervention Type DRUG

low volume polyethylene glycol 2 liter one time

Interventions

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Low volume PEG

low volume polyethylene glycol 2 liter one time

Intervention Type DRUG

high volume PEG

high volume polyethylene glycol 4 lilter split-dosing 2L/2L two times

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult outpatients and inpatients (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 medical condition such as severe cardiac
* Hepatic, renal failure (creatinine ≥ 3.0mg/dL (normal 0.8-1.4))
* Drug addiction or major psychiatric illness
* Suspected bowel obstruction or ileus
* Allergy to PEG
* Refusal of consent to participate in the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Inje University

OTHER

Sponsor Role lead

Responsible Party

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Eun Hee Seo, MD

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Haeundae Paik Hospital, Inje University School of Medicine

Busan, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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1.0-A2012

Identifier Type: -

Identifier Source: org_study_id

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