Inflammatory Bowel Disease Clinical Trial
Official title:
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic
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