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

Primary Purpose

Colonic Polyps, Cancer Colon, Inflammatory Bowel Disease

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
polyethylene glycol (PEG)
PEG low volume with bisacodyl
Sponsored by
Catholic University of the Sacred Heart
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colonic Polyps

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Digestive Endoscopy Unit of Catholic University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

polyethylene glycol (PEG)

PEG low volume with bisacodyl

Arm Description

Outcomes

Primary Outcome Measures

Evaluation of the overall quality of bowel preparation
Quality of preparation will be graded according to the Ottawa Scale.

Secondary Outcome Measures

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

Full Information

First Posted
February 7, 2012
Last Updated
February 11, 2012
Sponsor
Catholic University of the Sacred Heart
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1. Study Identification

Unique Protocol Identification Number
NCT01533090
Brief Title
Evaluation of Reduced-volume PEG Bowel Preparation Administered the Same Day of Colonoscopy
Acronym
LowVolumePEG
Official Title
Evaluation of Reduced-volume PEG Bowel Preparation Administered the Same Day of Colonoscopy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catholic University of the Sacred Heart

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Polyps, Cancer Colon, Inflammatory Bowel Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
162 (Actual)

8. Arms, Groups, and Interventions

Arm Title
polyethylene glycol (PEG)
Arm Type
Active Comparator
Arm Title
PEG low volume with bisacodyl
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
polyethylene glycol (PEG)
Intervention Description
SELG-ESSE 1000 4 L: 2L THE DAY BEFORE OF COLONOSCOPY AND 2 L THE SAME DAY OF COLONOSCOPY
Intervention Type
Drug
Intervention Name(s)
PEG low volume with bisacodyl
Intervention Description
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 Outcome Measure Information:
Title
Evaluation of the overall quality of bowel preparation
Description
Quality of preparation will be graded according to the Ottawa Scale.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
safety
Description
incidence and severity of the following GI unexpected adverse events: nausea, abdominal bloating, abdominal pain/cramps on a 5-point Likert scale
Time Frame
4 months
Title
compliance
Description
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)
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Digestive Endoscopy Unit of Catholic University
City
Rome
ZIP/Postal Code
00168
Country
Italy

12. IPD Sharing Statement

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

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