Colonoscopy Preparation Outcome
Conditions
Brief summary
The objective of this study is to evaluate sennosides as an adjunct to sodium picosulfate magnesium citrate (Pico Salax) in preparation for colonoscopy. We will compare different doses and administration times. The primary outcome is number of bowel motions produced. Secondary outcomes include the quality of bowel cleansing and patient tolerability.
Detailed description
We will compare different doses and administration times in patients booked for morning colonoscopy. The primary outcome is number of bowel motions produced in total by the sennosides. Secondary outcomes include the quality of bowel cleansing and patient tolerability.
Interventions
DRUGSennosides
Each group will be assigned different doses of sennosides and varying times of administration
Sponsors
Queen's University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male and non-pregnant female patients 18 to 75 years of age inclusive * Patients who require an outpatient colonoscopy with a split dose Pico-Salax prep
Exclusion criteria
* Colonoscopy requiring the use of a large volume prep (eg Colyte, PEG) * Ileus or bowel obstruction * Previous colorectal surgery * Ascites * Recognized renal impairment (defined as GFR less than normal in 3 months prior to enrolment) * Pregnancy * Recent (\<6 months) myocardial infarction or unstable angina.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bowel movements, as measured by patient diary | 2 days | The primary outcome of this pilot study is the number of bowel movements. Patients will record the timing and number of bowel motions produced. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Colon cleansing, as measured by The Ottawa Scale and Aronchick Bowel Cleansing Scale | 2 days | The secondary outcome is colon cleansing efficacy. The endoscopist will grade the cleansing quality of the colon using two standardized measures - the Ottawa Scale and the 5-point Aronchick Bowel Preparation Scale |
| Tolerability, as measured by patient questionnaire | 2 days | The secondary outcome is patient tolerability. Patients will be asked to complete a questionnaire examining symptoms such as nausea, bloating, vomiting, and abdominal pain. |
Countries
Canada
Outcome results
None listed