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

March 30, 2012 updated by: Eun Hee Seo, MD, Inje University

Efficacy and Tolerability of Morning (AM) Only Low Volume (2L) PEG With Low Residue Test Meals Versus High Volume (4L) Split-dose (PM/AM) PEG Bowel Preparation With Standard Meals: A Prospective Randomized, Investigator Blinded Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

188

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 612-030
        • Haeundae Paik Hospital, Inje University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: High volume PEG
Patients who are scheduled colonoscopy ingest high volume PEG(4L) for bowel preparation.
Drug: high volume PEG
high volume polyethylene glycol 4 lilter split-dosing 2L/2L two times
Active Comparator: 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.
Drug: Low volume PEG
low volume polyethylene glycol 2 liter one time

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of bowel preparation
Time Frame: 2 months
Quality of bowel preparation is assessed using Ottawa bowel preparation scale.
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tolerability
Time Frame: 2 months
Tolerability of bowel preparation regimen is assessed by patient questionnaire.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inje University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

March 29, 2012

First Submitted That Met QC Criteria

March 29, 2012

First Posted (Estimate)

April 2, 2012

Study Record Updates

Last Update Posted (Estimate)

April 3, 2012

Last Update Submitted That Met QC Criteria

March 30, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1.0-A2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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