Polyethylene Glycol Solution, Risk Factors Inadequate Preparation, Split-dose Bowel Preparation
Conditions
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.
Interventions
OTHERindividual preparation for colonoscopy
The volume of polyethylene glycol solution depends on risk factors presented in each patient. Time of administration of second dose will be confirmed according to the time of colonoscopy. In case of constipation an enema before colonoscopy will be administered. All patients will give educational booklet of preparation before colonoscopy
Sponsors
Maria Sklodowska-Curie National Research Institute of Oncology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the index of preparation quality for the whole colon | 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
| Measure | Time frame | Description |
|---|---|---|
| compliance safety | 24 hours | number of patients with completion of preparation number of patients with side effects of preparation in each group |
Countries
Poland
Outcome results
None listed