The Use of Sennosides With Pico Salax in Bowel Preparation for Colonoscopy: a Study of Optimal Dose and Timing
- Registration Number
- NCT02618564
- Lead Sponsor
- Queen's University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 TABS AM Sennosides Sennosides 3 tabs, taken the morning before the colonoscopy 2 TABS QHS Sennosides Sennosides 2 tabs, taken two nights before the colonoscopy 3 TABS QHS Sennosides Sennosides 3 tabs, taken two nights before the colonoscopy 2 TABS AM Sennosides Sennosides 2 tabs, taken the morning before the colonoscopy 2 TABS AM & QHS Sennosides Sennosides 2 tabs taken the morning before and 2 tabs taken the evening before the colonoscopy.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Hotel Dieu Hospital
🇨🇦Kingston, Ontario, Canada