Individual Approach for Bowel Preparation Before Colonoscopy

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective, Randomized, Single-blind Study Evaluating Individual Approach on Bowel Preparation Quality for Colonoscopy

Conditions
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Split-dose Bowel Preparation, Polyethylene Glycol Solution, Risk Factors Inadequate Preparation

Intervention / Treatment
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* Other: individual preparation for colonoscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: split-dose polyethylene glycol solution<br>first dose (1,5 l) of polyethylene glycol solution taken at 6-7.00 in the evening before colonoscopy, second dose (1,5 l) taken at 5.30-6.00 in the morning of a day of colonoscopy; additional bisacodyl taken at 12.00 at the day before colonoscopy | Other: individual preparation for colonoscopy<br>* 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<br>|
| Active Comparator: Individual preparation for colonoscopy<br> | Other: individual preparation for colonoscopy<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the index of preparation quality for the whole colon | 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 | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| compliance safety | number of patients with completion of preparation number of patients with side effects of preparation in each group | 24 hours |