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

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.

Study Overview

• Status: Completed
• Conditions: Colonic Polyps; Inflammatory Bowel Disease; Cancer Colon
• Intervention / Treatment: Drug: polyethylene glycol (PEG); Drug: PEG low volume with bisacodyl

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: Interventional
• Enrollment (Actual): 162
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00168
    • Digestive Endoscopy Unit of Catholic University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: polyethylene glycol (PEG)	Drug: polyethylene glycol (PEG); SELG-ESSE 1000 4 L: 2L THE DAY BEFORE OF COLONOSCOPY AND 2 L THE SAME DAY OF COLONOSCOPY
Experimental: PEG low volume with bisacodyl	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the overall quality of bowel preparation	Quality of preparation will be graded according to the Ottawa Scale.	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
safety	incidence and severity of the following GI unexpected adverse events: nausea, abdominal bloating, abdominal pain/cramps on a 5-point Likert scale	4 months
compliance	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)	4 months

Collaborators and Investigators

• Sponsor: Catholic University of the Sacred Heart

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: February 7, 2012
• First Submitted That Met QC Criteria: February 11, 2012
• First Posted (Estimate): February 15, 2012

Study Record Updates

• Last Update Posted (Estimate): February 15, 2012
• Last Update Submitted That Met QC Criteria: February 11, 2012
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Pathological Conditions, Anatomical; Polyps; Intestinal Polyps; Inflammatory Bowel Diseases; Colonic Polyps; Gastrointestinal Agents; Cathartics; Laxatives; Bisacodyl
• Other Study ID Numbers: PMF 105