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Completed

NCT Number: NCT01568814

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

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.

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Key information

Conditions

Bowel Preparation Colonoscopy

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Haeundae Paik Hospital, Inje University School of Medicine

Busan, 612-030, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low volume PEG

Drug

low volume polyethylene glycol 2 liter one time

high volume PEG

Drug

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

Primary outcomes

  1. Quality of bowel preparation

    Time frame: 2 months

    Quality of bowel preparation is assessed using Ottawa bowel preparation scale.

Secondary outcomes

  1. Tolerability

    Time frame: 2 months

    Tolerability of bowel preparation regimen is assessed by patient questionnaire.

Sponsors and collaborators

Lead sponsor

Inje University

Other

Registry information

Official study title

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

Acronym: LOWPEG

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Apr 2, 2012
Registry last updated
Apr 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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