A Prospective, Randomized, Single-blind Study Evaluating Individual Approach on Bowel Preparation Quality for Colonoscopy
18 Years
N/A
Both
Split-dose Bowel Preparation, Polyethylene Glycol Solution, Risk Factors Inadequate Preparation
Trial Information
A Prospective, Randomized, Single-blind Study Evaluating Individual Approach on Bowel Preparation Quality for Colonoscopy
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
the index of preparation quality for the whole colon
Outcome Description:
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
Outcome Time Frame:
24 hours
Safety Issue:
No
Principal Investigator
Jaroslaw Regula, MD, PhD
Investigator Role:
Study Director
Investigator Affiliation:
Maria Sklodowska-Curie Memorial cancer Center, Institute of Oncology, Warsaw, Poland
Authority:
Poland: Ethics Committee
Study ID:
Individual bowel preparation
NCT ID:
NCT01476735
Start Date:
August 2011
Completion Date:
March 2012
Related Keywords:
- Split-dose Bowel Preparation
- Polyethylene Glycol Solution
- Risk Factors Inadequate Preparation
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