Bowel Preparation Solutions, Endoscopy
Conditions
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.
Interventions
DRUGBisacodyl 10mg
Given at the start of the bowel preparation the day before colonoscopy
DRUGPolyethelene Glycol
280g reconstituted in 4 liters of water
DRUGPicosulfate sodium
Two sachets, Each sachet has 10mg dose
Sponsors
McMaster University
St. Joseph's Healthcare Hamilton
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Inpatient colonoscopy * Age greater than 18 years old * Able to give consent
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ottawa Bowel Prep Score | 30 minutes after procedure | Using a standardized, validated score for measuring quality of bowel preparation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Canada
Contacts
Primary ContactLisa Balogh Melanson, BSc
Outcome results
None listed