Bowel Preparation
Conditions
Keywords
patient tolerability, quality
Brief summary
Introduction: Colonoscopy is an important tool for colon cancer screening. Proper colon cleansing is essential to ensure adequate mucosal examination. Timing of bowel preparation administration is now recognized as an important component for achieving superior cleansing. Multiple randomized controlled trials and meta-analyses have found split-dosing to be superior than day-before dosing. Objective: This study aims to compare two types of bowel preparations in split-doses to assess for differences in patient tolerability, as well as efficacy of colon cleansing. Methods: This is a prospective, single-blinded, randomized-controlled trial. Patients who are being referred for a colonoscopy will be recruited to participate in the study. They will be randomly assigned to receive either a split-dose polyethylene glycol (PEG) or picosalax (P/MC) bowel preparation. Patient tolerability will be examined through questionnaires. The endoscopist performing the colonoscopy will use two standardized bowel preparation scoring systems to evaluate the quality of the cleansing. The investigators propose that P/MC will be superior to PEG in patient tolerability and non-inferior in bowel cleansing effects.
Interventions
DRUGPolyethylene Glycol
DRUGPicosalax
Sponsors
Queen's University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* All male and non-pregnant female patients between ages 18 and 75 years old who require outpatient colonoscopy
Exclusion criteria
* ileus or bowel obstruction, previous colorectal surgery, ascites, recognized renal impairment, defined as GFR less than normal in 3 months prior to enrollment, active inflammatory bowel disease, insulin dependent diabetes, pregnancy, or recent (\<6 months) myocardial infarction or unstable angina
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient tolerability | Two days | Patients will be asked to complete a questionnaire to assess ease of completion and symptoms. Questionnaire items are weighted on a 5-point Likert scale. Interference with sleep will be assessed through a questionnaire that is based on a modified validated sleep questionnaire (St. Mary's Hospital Sleep Questionnaire). Participants will be asked to complete this questionnaire at the initial appointment and again on the day of their procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of bowel preparation | During colonoscopy | The colonoscopist will be blinded to the type of preparation the subject underwent. The colonoscopist will complete a validated questionnaire to assess the quality of the preparation (The Ottawa Scale) and the 4-point Aronchick bowel cleansing scale. The patient's baseline bowel habit will be recorded, as well as the withdrawal time, volume of liquid suctioned and volume of washing fluid used during the colonoscopy. |
Countries
Canada
Outcome results
None listed