NCT02908919UnknownPhase 4
Impact of Time Intervals on Quality and Tolerance of the Bowel Preparation
Faculty Hospital Kralovske Vinohrady4 sites in 1 country480 target enrollmentStarted: August 1, 2016Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 480
- Locations
- 4
- Primary Endpoint
- Quality of bowel preparation according to time intervals of bowel preparation
Study Overview
Brief Summary
The purpose of this study is to determine optimal time intervals for preparation before colonoscopy using different formulas.
Detailed Description
Different formulas are used for bowel preparation before colonoscopy. Present guidelines are based on conventional polyethylene glycol. Their validity for other preparations were not evaluated. Relationship between length of preparation, interval to colonoscopy and bowel preparation quality, tolerance are assessed.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •subjects referred to diagnostic or therapeutic colonoscopy.
Exclusion Criteria
- •known or suspected bowel obstruction
- •active bowel inflammation
- •pregnancy
- •any presence of serious medical conditions ( esp. cardiac, renal, liver diseases)
- •history of prior colonic or rectal surgery
- •inability to obtain valid data from
Outcomes
Primary Outcomes
Quality of bowel preparation according to time intervals of bowel preparation
Time Frame: One day
The length of bowel preparation and interval to colonoscopy for bowel preparation quality Aronchick score excellent and good
Secondary Outcomes
- Tolerance of bowel preparation according to time intervals of bowel preparation(One day)
Investigators
MUDr. Jan Matous
Jan Matous, MD
Faculty Hospital Kralovske Vinohrady
Study Sites (4)
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