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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Guido Costamagna, Catholic University of the Sacred Heart

ClinicalTrials.gov Identifier:

NCT01533090

First received: February 7, 2012

Last updated: February 11, 2012

Last verified: March 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	February 7, 2012
Last Updated Date	February 11, 2012
Start Date ^ICMJE	April 2010
Primary Completion Date	November 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 11, 2012)	Evaluation of the overall quality of bowel preparation [ Time Frame: 4 months ] [ Designated as safety issue: No ] Quality of preparation will be graded according to the Ottawa Scale.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01533090 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 11, 2012)	safety [ Time Frame: 4 months ] [ Designated as safety issue: Yes ] incidence and severity of the following GI unexpected adverse events: nausea, abdominal bloating, abdominal pain/cramps on a 5-point Likert scale compliance [ Time Frame: 4 months ] [ Designated as safety issue: No ] 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)
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Evaluation of Reduced-volume PEG Bowel Preparation Administered the Same Day of Colonoscopy
Official Title ^ICMJE	Evaluation of Reduced-volume PEG Bowel Preparation Administered the Same Day of Colonoscopy
Brief Summary	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.
Detailed Description	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.
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Diagnostic
Condition ^ICMJE	Colonic Polyps Cancer Colon Inflammatory Bowel Disease
Intervention ^ICMJE	Drug: polyethylene glycol (PEG) SELG-ESSE 1000 4 L: 2L THE DAY BEFORE OF COLONOSCOPY AND 2 L THE SAME DAY OF COLONOSCOPY Drug: PEG low volume with bisacodyl 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
Study Arm (s)	Active Comparator: polyethylene glycol (PEG) Intervention: Drug: polyethylene glycol (PEG) Experimental: PEG low volume with bisacodyl Intervention: Drug: PEG low volume with bisacodyl
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	162
Completion Date	November 2010
Primary Completion Date	November 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 85 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Italy

Administrative Information
NCT Number ^ICMJE	NCT01533090
Other Study ID Numbers ^ICMJE	PMF 105
Has Data Monitoring Committee	Yes
Responsible Party	Guido Costamagna, Catholic University of the Sacred Heart
Study Sponsor ^ICMJE	Catholic University of the Sacred Heart
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Catholic University of the Sacred Heart
Verification Date	March 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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