Bowel Cleansing for Colonoscopy: Comparison Between a Same Day Low-Volume Preparation and a Conventional 4L Split One
2 other identifiers
interventional
164
1 country
1
Brief Summary
The present study is intended to evaluate the effectiveness, tolerability, compliance, and feasibility of the low volume bowel preparation, bisacodyl tablets followed by 2L Polyethylene glycol (PEG) with citrate and simethicone (CS) given the same day of colonoscopy, vs the standard 4L split PEG solution.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2011
Shorter than P25 for phase_3
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, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 12, 2012
CompletedFirst Posted
Study publicly available on registry
September 14, 2012
CompletedSeptember 19, 2012
September 1, 2012
11 months
September 12, 2012
September 18, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Efficacy
Evaluation of the quality of bowel preparation according to the Ottawa Scale
20 min
Secondary Outcomes (6)
Efficacy
20 min
Efficacy
20 min
Safety
24 hours
Tolerability
24 hours
Acceptability
24 hours
- +1 more secondary outcomes
Study Arms (2)
PEG 4 litres split
ACTIVE COMPARATORPolyethylene glycol with electrolytes (PEG)
Bisacodyl plus PEG-CS
EXPERIMENTALBisacodyl plus PEG-CS: Bisacodyl plus Polyethylene glycol with citrate and simethicone (PEG-CS)
Interventions
* the day before colonoscopy: 3-4 bisacodyl tablets (according to patient bowel habit) at bedtime * the morning of colonoscopy: PEG-CS (2 litres) starting 5 hours before the exam
* the day before colonoscopy: 2 litres of PEG * the morning of colonoscopy: 2 litres of PEG starting 5 hours before the examination
Eligibility Criteria
You may qualify if:
- Out-patients undergoing a complete colonoscopy
- Patient written informed consent
You may not qualify if:
- Pregnant or lactating women or at a risk of becoming pregnant
- Known or suspected gastrointestinal obstruction or perforation; toxic megacolon; major colonic resection Known or suspected hypersensitivity to the active principle and/or formulations' ingredients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
European Institute of Oncology
Milan, 20141, Italy
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cristiano Crosta, MD
European Institute of Oncology
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2012
First Posted
September 14, 2012
Study Start
April 1, 2011
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
September 19, 2012
Record last verified: 2012-09