Know Cancer

forgot password

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

18 Years
85 Years
Not Enrolling
Colonic Polyps, Cancer Colon, Inflammatory Bowel Disease

Thank you

Trial Information

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

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

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Outcome Measure:

Evaluation of the overall quality of bowel preparation

Outcome Description:

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

Outcome Time Frame:

4 months

Safety Issue:



Italy: Ethics Committee

Study ID:

PMF 105



Start Date:

April 2010

Completion Date:

November 2010

Related Keywords:

  • Colonic Polyps
  • Cancer Colon
  • Inflammatory Bowel Disease
  • Colonic Polyps
  • Inflammatory Bowel Diseases
  • Intestinal Diseases