A Phase 4 interventional study of Bisacodyl 10mg and Polyethelene Glycol in Endoscopy and Bowel Preparation Solutions, sponsored by St. Joseph's Healthcare Hamilton. Status unknown at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-01-30.
Sponsored by St. Joseph's Healthcare Hamilton · Phase 4, Interventional, and Treatment
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.
St. Joseph's Healthcare Hamilton is the lead sponsor of 137 studies on the registry; 31 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
PEGlyte to be reconstituted with 4L of water and taken in the evening before the colonoscopy.
Drug: Bisacodyl 10mg · Drug: Polyethelene Glycol
Two sachets of Pico-Salax with 1 taken the night before colonoscopy and the second taken the morning of colonoscopy.
Drug: Bisacodyl 10mg · Drug: Picosulfate sodium
2 sachets of Pico Salax mixed with water taken about 4 hours apart the night before colonoscopy
Drug: Bisacodyl 10mg · Drug: Picosulfate sodium
Given at the start of the bowel preparation the day before colonoscopy
280g reconstituted in 4 liters of water
Also known as: PEG-Lyte
Two sachets, Each sachet has 10mg dose
Also known as: Pico-Salax
Ottawa Bowel Prep Score
Using a standardized, validated score for measuring quality of bowel preparation
Time frame: 30 minutes after procedure
Procedures Cancelled or repeated due to inadequate bowel preparation
If bowel preparation is deemed inadequate to the point the procedure must be cancelled or rescheduled
Time frame: During admission (average of 2 weeks)
Individual Components of Ottawa Bowel Prep Score
Each section of prep score evaluating the right, mid, and left colon, as well as the fluid score will be analyzed individually
Time frame: 30 minutes after procedure
Adverse Effects
Any adverse effects that may be attributed to the intervention
Time frame: Up to 48 hours after procedure
Tolerability of the preparation
A questionnaire to assess the overall tolerability of the preparation.
Time frame: Within 1 day of intervention
This study is status unknown, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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St. Joseph's Healthcare Hamilton