Polyethylene Glycol Versus Low Volume Solutions Prior to Colonoscopy

Study Overview
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Brief Summary
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Study evaluates the efficacy and tolerability of low volume preparations compared with conventional 4L polyethylene glycol prior to colonoscopy

Detailed Description
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To compare the efficacy and tolerance of standard polyethylene glycol to low volume sodium picosulphate/magnesium citrate and polyethylene glycol/ascorbic acid in a single or split dose regimen for colonoscopy bowel preparation in a head-to-head design.

Official Title
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A Head-to-head Comparison of Efficiency and Tolerance of 4-L Polyethylene Glycol and Sodium Picosulphate/ Magnesium Citrate, Polyethylene Glycol/Ascorbate Before Colonoscopy

Conditions
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Colonoscopy

Intervention / Treatment
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* Drug: Polyethylene Glycols
* Drug: Natrium picosulfate / Magnesium citrate
* Drug: Polyethylene glycol / Ascorbic acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects referred to diagnostic or therapeutic colonoscopy Exclusion Criteria: ileus known or suspected bowel obstruction active bowel inflammation pregnancy any presence of serious medical conditions history of prior colonic or rectal surgery inability to obtain valid data from subject

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: PEG1D<br>Polyethylene glycols single dose a day before colonoscopy | Drug: Polyethylene Glycols<br> <br> |
| Active Comparator: PEG2D<br>Polyethylene glycols split dose | Drug: Polyethylene Glycols<br> <br> |
| Active Comparator: SPMC1D<br>Natrium picosulfate/ Magnesium citrate single dose day before colonoscopy | Drug: Natrium picosulfate / Magnesium citrate<br> <br> |
| Active Comparator: SPMC2D<br>Natrium picosulfate/ Magnesium citrate split dose | Drug: Natrium picosulfate / Magnesium citrate<br> <br> |
| Active Comparator: PEGA1D<br>Polyethylene glycol / Ascorbic acid single dose day before colonoscopy | Drug: Polyethylene glycol / Ascorbic acid<br> <br> |
| Active Comparator: PEGA2D<br>Polyethylene glycol / Ascorbic acid split dose | Drug: Polyethylene glycol / Ascorbic acid<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Bowel Preparation Using the Aronchick Scale ( Score 1+2) | Bowel preparation score 1+2 expressed on Aronchick scale (1 the best, 5 the worst) | One day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerance of Bowel Preparation Assessed by 5 Point VAS ( Score 1+2) | Tolerance of Bowel Preparation Assessed by VAS score 1+2 ( 1-excellent, 5-very poor) | One day |