Split Dose Pico-Salax + Bisacodyl vs. PEG Split Dose
Information source: University of Calgary
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bowel Preparation for Colonoscopy
Intervention: Polyethylene Glycol-Based Lavage (Drug); Pico-Salax (Magnesium Citrate) plus Bisacodyl (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: University of Calgary Official(s) and/or principal investigator(s):
Alaa Rostom, MD, Principal Investigator, Affiliation: University of Calgary Faculty of Medicine
Overall contact:
Eleanor C Rushton, B.Sc., Phone: 403-592-5087, Email: ecrushto@ucalgary.ca
Summary
The objective of this study is to compare the efficacy, safety and tolerability of two bowel
preparations for colonoscopy - split dose Polyethylene Glycol-Based Lavage and Pico-Salax plus Bisacodyl - with a specific emphasis on the right colon cleanliness.
The primary outcomes will be 1) quality of preparation in cleansing the colon, 2) quality of
preparation in cleansing the right colon, 3) patient satisfaction. The secondary outcomes
will be 1) duration of bowel preparation, 2) patient discomfort during bowel preparation.
Clinical Details
Official title: A Randomized Prospective Trial Comparing Pico-Salax (Magnesium Citrate) Plus Bisacodyl Versus Split Dose Polyethylene Glycol-Based Lavage In Preparation Of Patients For Colonoscopy
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)
Primary outcome: Quality of Bowel Cleanliness
Secondary outcome: Patient Satisfaction with preparation
Detailed description:
All patients referred to the Forzani MacPhail Colon Cancer Screening Centre (CCSC) in
Calgary, Alberta, Canada for colonoscopy will be considered for inclusion. During
pre-assessments at the clinic, patients are asked to consider a general research consent. If
they agree to that, then they will be approached for consideration of participating in this
study and presented with an "Invitation to Participate in a Research Study" form (appendix);
the study assistant will obtain final consent if they agree. Those not interested in
participating will simply receive their physician's standard bowel preparation protocol.
There will be no coercion of any sort. Enrollment of participants will be performed with
block randomizations of 8 by using a computer-generated table, with allocation concealment
maintained through the use of consecutively numbered sealed envelopes. Colonoscopists and
investigators will be blinded to allocation groups. Patients will be allocated to one of
two groups: (1) oral Pico-Salax (two sachets, with 1. 5-2L of water following each sachet)
with Dulcolax (Bisacodyl, 4 tablets); (2) split dose Polyethylene Glycol-Based Lavage (2L +
2L).
A study assistant will assign patients to their group and instruct them on the proper use of
their assigned bowel preparation method. Patients will be given a tolerability
questionnaire, which has been modified from a previously used questionnaire, to be completed
once their bowel preparation is finished and before coming to the CCSC for the colonoscopy
(included in the appendix). Patient concerns or questions regarding the preparation will be
directed toward the study assistant or clinic nurses as opposed to their endoscopist, so as
to avoid un-blinding the Colonoscopist. The physician performing the procedure will then
complete an Ottawa Bowel Preparation Scale and a validated Simplified Bowel Preparation
scale to assess colon cleanliness.
Eligibility
Minimum age: 18 Years.
Maximum age: 74 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 18 to 74 years referred to the in Calgary, Alberta, Canada for colonoscopy will be
considered for inclusion
Exclusion Criteria:
- Any history of kidney problems
Locations and Contacts
Eleanor C Rushton, B.Sc., Phone: 403-592-5087, Email: ecrushto@ucalgary.ca
Foranzi & MacPhail Colon Cancer Screening Centre, Alberta Health Services, Calgary, Alberta T2N 4Z6, Canada; Recruiting
Eleanor C Rushton, B.Sc, Phone: 403-592-5087, Email: ecrushto@ucalgary.ca
Robert Hilsden, MD, Phone: 403-592-5042, Email: rhilsden@ucalgary.ca
Alaa Rostom, MD, Principal Investigator
Robert Hilsden, MD, Principal Investigator
Catherine Dube, MD, Principal Investigator
Foranzi & MacPhail Colon Cancer Screening Centre, Calgary, Alberta T2N 4Z6, Canada; Recruiting
Eleanor C Rushton, B.Sc, Phone: 403-592-5087, Email: ecrushto@ucalgary.ca
Robert Hilsden, MD, Phone: 403-592-5042, Email: rhilsden@ucalgary.ca
Alaa Rostom, MD, Principal Investigator
Robert Hilsden, MD, Sub-Investigator
Catherine Dube, MD, Sub-Investigator
Additional Information
Starting date: May 2011
Last updated: August 11, 2011
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