Evaluation of Reduced-volume PEG Bowel Preparation Administered the Same Day of Colonoscopy
LowVolumePEG
1 other identifier
interventional
162
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2010
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 7, 2012
CompletedFirst Posted
Study publicly available on registry
February 15, 2012
CompletedFebruary 15, 2012
March 1, 2010
7 months
February 7, 2012
February 11, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluation of the overall quality of bowel preparation
Quality of preparation will be graded according to the Ottawa Scale.
4 months
Secondary Outcomes (2)
safety
4 months
compliance
4 months
Study Arms (2)
polyethylene glycol (PEG)
ACTIVE COMPARATORPEG low volume with bisacodyl
EXPERIMENTALInterventions
SELG-ESSE 1000 4 L: 2L THE DAY BEFORE OF COLONOSCOPY AND 2 L THE SAME DAY OF COLONOSCOPY
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
Eligibility Criteria
You may qualify if:
- both sexes
- aged between 18 and 85 yr
- undergoing a complete colonoscopy
You may not qualify if:
- 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
- known or suspected hypersensitivity to the active principles or other ingredients
- history of anaphylaxis to drugs or allergic reactions in general
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Digestive Endoscopy Unit of Catholic University
Rome, Italy, 00168, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 7, 2012
First Posted
February 15, 2012
Study Start
April 1, 2010
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
February 15, 2012
Record last verified: 2010-03