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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: March 2012

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

Interventions

  • Drug: Low volume PEG
    • low volume polyethylene glycol 2 liter one time
  • Drug: high volume PEG
    • high volume polyethylene glycol 4 lilter split-dosing 2L/2L two times

Arms, Groups and Cohorts

  • Placebo Comparator: High volume PEG
    • Patients who are scheduled colonoscopy ingest high volume PEG(4L) for bowel preparation.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Quality of bowel preparation
    • Time Frame: 2 months
    • Quality of bowel preparation is assessed using Ottawa bowel preparation scale.

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Inje University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Eun Hee Seo, MD, Principal investigator – Inje University

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