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Completed

NCT Number: NCT01533090

Evaluation of Reduced-volume PEG Bowel Preparation Administered the Same Day of Colonoscopy

The conventional total dose of 4 L of polyethylene glycol (PEG) given the day before the procedure is safe and effective. It has been the standard cleansing regimen for the last 25 years. To overcome the difficulty in completing the bowel preparation due to large volume and/or taste, reduced-volume (mixed) bowel preparation of bisacodyl and 2 L of PEG have been shown to provide adequate colon cleansing and better tolerability.

LoVol-esse is a reduced-volume PEG-based bowel preparation to be used in combination with bisacodyl and designed to improve patient tolerability and attitude toward bowel cleansing prior to colonoscopy thanks to the reduced volume and improved taste. The present study is intended to compare the new dosing regimen of the bowel lavage solution given the same day compared with standard PEG formulation (SELG 1000) given the day before colonoscopy.

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Key information

About this study

A polyethylene glycol (PEG) electrolyte lavage solution (PEG-ELS) was originally developed in 1980 by the Fordtran group as isosmotic preparation for minimal water and electrolyte exchange with plasma to ensure safe cleansing of the bowel through a mechanical effect of large-volume lavage. The conventional total dose of 4 L given the day before the procedure is safe and effective and has been the standard cleansing regimen for the last 25 years. To overcome the difficulty in completing the bowel preparation due to large volume and/or taste, reduced-volume (mixed) bowel preparation of bisacodyl and 2 L of PEG-ELS have been shown to provide adequate colon cleansing and better tolerability.

In the last recent years, time of preparation has been demonstrated to be a critical factor for bowel preparation for colonoscopy. Several studies have demonstrated that reducing the time interval between the completion of bowel preparation and the exam improves colon cleansing compared with standard dose regimen of the PEG-electrolyte solution given the day before colonoscopy. At the same time manufacturers have tried to improve the taste and palatability of PEG formulations by adding suitable ingredients such as ascorbic acid or citric acid. LoVol-esse is a reduced-volume PEG-based bowel preparation to be used in combination with bisacodyl and designed to improve patient tolerability and attitude toward bowel cleansing prior to colonoscopy thanks to the reduced volume and improved taste. The present study is intended to compare the new dosing regimen of the bowel lavage solution given the same day compared with standard PEG formulation (SELG 1000) given the day before colonoscopy.

The results of this study will tells us if the last-hour preparation is effective and offers adequate tolerability and compliance to be adopted in clinical practice.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • both sexes
  • aged between 18 and 85 yr
  • undergoing a complete colonoscopy

Exclusion criteria

  • known or suspected gastrointestinal obstruction or perforation
  • toxic megacolon
  • major colonic resection
  • pregnant or at risk of becoming pregnant women
  • lactating women
  • inability to comprehend the full nature and purpose of the study
  • no signed informed consent prior to inclusion in the study
  • known or suspected hypersensitivity to the active principles or other ingredients
  • history of anaphylaxis to drugs or allergic reactions in general

Treatment and study plan

Polyethylene Glycol (PEG)

Drug

SELG-ESSE 1000 4 L: 2L THE DAY BEFORE OF COLONOSCOPY AND 2 L THE SAME DAY OF COLONOSCOPY

PEG low volume with bisacodyl

Drug

Lovolesse + Lovoldyl 2L of Lovolesse with 2 or 3 tablets of bisacodyl the day before of colonoscopy or 2L of Lovolesse with 2 or 3 tablets of bisacodyl the same day of colonoscopy

Primary outcomes

  1. Evaluation of the overall quality of bowel preparation

    Time frame: 4 months

    Quality of preparation will be graded according to the Ottawa Scale.

Secondary outcomes

  1. safety

    Time frame: 4 months

    incidence and severity of the following GI unexpected adverse events: nausea, abdominal bloating, abdominal pain/cramps on a 5-point Likert scale

  2. compliance

    Time frame: 4 months

    Proportion of patients able to:

    • drink < 75% of the solution (poor compliance)
    • drink at least 75% of the solution (good compliance)
    • drink all the solution (optimal compliance)

Sponsors and collaborators

Lead sponsor

Catholic University of the Sacred Heart

Other

Registry information

Acronym: LowVolumePEG

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Feb 15, 2012
Registry last updated
Feb 15, 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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