Colonoscopy Preparation Optimization for INpatients- COIN Study
- Conditions
- EndoscopyBowel Preparation Solutions
- Interventions
- Registration Number
- NCT01627171
- Lead Sponsor
- St. Joseph's Healthcare Hamilton
- Brief Summary
Colonoscopic examinations are performed routinely in hospitalized patients for a variety of indications. However, numerous limitations exist in hospitalized patients preventing an endoscopist from performing high quality examinations; possibly necessitating repeated procedures leading to increased cost and re-exposure to their inherent risks. One such prominent challenge lays in the adequacy of bowel cleansing. Inpatient status has been shown to be a predictor of poor bowel preparation as these patients are older, less mobile and have more co morbidities than the outpatient population. Currently, no standardized (or optimized) bowel preparation type or regimen for administration exists for the hospital inpatient population undergoing colonoscopy. Studies in the outpatient population have demonstrated that timing and choice of cathartic medication effects the cleanliness of the bowel preparation but there is no such clinical evidence for in-patients who receive whatever cathartic agent is on hospital formulary. The purpose of the study is compare efficacy, patient satisfaction, and adverse effects associated with low volume cathartic (Pico-Salax) to the current standard volume 4 liter (PEG-Lyte) and the effect of alternate timing of dosages.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 126
- Inpatient colonoscopy
- Age greater than 18 years old
- Able to give consent
- No consent obtained
- Pregnancy or lactating
- Renal impairment
- Severe CHF (NYHA class 3/4)
- Recent myocardial infarction (preceding 6 months)
- Ileus
- Ascites
- Severe Colitis
- Toxic Megacolon
- Gastrointestinal Obstruction
- PEG tube
- Previous large bowel resection
- Allergy to study drug
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pico Salax Split Bisacodyl 10mg Two sachets of Pico-Salax with 1 taken the night before colonoscopy and the second taken the morning of colonoscopy. PEG Lyte Bisacodyl 10mg PEGlyte to be reconstituted with 4L of water and taken in the evening before the colonoscopy. PEG Lyte Polyethelene Glycol PEGlyte to be reconstituted with 4L of water and taken in the evening before the colonoscopy. Pico Salax Split Picosulfate sodium Two sachets of Pico-Salax with 1 taken the night before colonoscopy and the second taken the morning of colonoscopy. Pico Salax Night Before Bisacodyl 10mg 2 sachets of Pico Salax mixed with water taken about 4 hours apart the night before colonoscopy Pico Salax Night Before Picosulfate sodium 2 sachets of Pico Salax mixed with water taken about 4 hours apart the night before colonoscopy
- Primary Outcome Measures
Name Time Method Ottawa Bowel Prep Score 30 minutes after procedure Using a standardized, validated score for measuring quality of bowel preparation
- Secondary Outcome Measures
Name Time Method Procedures Cancelled or repeated due to inadequate bowel preparation During admission (average of 2 weeks) If bowel preparation is deemed inadequate to the point the procedure must be cancelled or rescheduled
Individual Components of Ottawa Bowel Prep Score 30 minutes after procedure Each section of prep score evaluating the right, mid, and left colon, as well as the fluid score will be analyzed individually
Adverse Effects Up to 48 hours after procedure Any adverse effects that may be attributed to the intervention
Tolerability of the preparation Within 1 day of intervention A questionnaire to assess the overall tolerability of the preparation.
Trial Locations
- Locations (1)
St Joseph Hospital
🇨🇦Hamilton, Ontario, Canada