A Prospective, Randomized, Single-blind Study Evaluating Individual Approach on Bowel Preparation Quality for Colonoscopy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Split-dose Bowel Preparation
- Sponsor
- Maria Sklodowska-Curie National Research Institute of Oncology
- Enrollment
- 266
- Locations
- 1
- Primary Endpoint
- the index of preparation quality for the whole colon
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
This is a prospective, randomized, single-blind study designed to evaluate the influence of individual approach on bowel preparation quality for colonoscopy. The investigators compare split-dose polyethylene glycol solution (PEG, Fortrans, Beaufour Ipsen) to modified split-dose PEG regarding predictors of inadequate preparation for colonoscopy.
Detailed Description
Up to 22% of patients are not good prepared for colonoscopy and it is caused of aborted procedures and increased costs. There are identified predictors of inadequate bowel preparation before colonoscopy, but we still don't know if an individual approach improve the quality of preparation.
Investigators
Eligibility Criteria
Inclusion Criteria
- •men and women more than 18 years of age undergoing colonoscopy for routine clinical indications
- •provided written informed consent
Exclusion Criteria
- •lack of written informed consent or inability to provide informed consent or refusal to consent to the study
- •pregnancy and breast feeding
- •known allergy to PEG or bisakodyl
- •presence of serious conditions such as severe cadiac, renal or metabolic diseases, major psychiatric illness or end-stage cancer disease requiring taking narcotic drugs
- •colonoscopy performed under conscious sedation
Outcomes
Primary Outcomes
the index of preparation quality for the whole colon
Time Frame: 24 hours
the percentage of patients with adequate bowel preparation; adequate preparation is defined as excellent, good and fair, inadequate is defined as poor or unprepared colon according to the Ottawa bowel preparation scale
Secondary Outcomes
- compliance safety(24 hours)