Split Dose Pico-Salax + Bisacodyl vs. PEG Split Dose
BP
A Randomized Prospective Trial Comparing Pico-Salax (Magnesium Citrate) Plus Bisacodyl Versus Split Dose Polyethylene Glycol-Based Lavage In Preparation Of Patients For Colonoscopy
1 other identifier
interventional
171
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2011
Shorter than P25 for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 5, 2011
CompletedFirst Posted
Study publicly available on registry
August 12, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedMay 31, 2012
May 1, 2012
7 months
August 5, 2011
May 30, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quality of Bowel Cleanliness
Ottawa bowel Prep scale will be done by the Dr. to assess the quality of bowel cleanliness. The right, mid and rectosigmoid colon are each rated on a 5-point scale (0-4). Also, a complete 3-point rating for overall colonic fluid is assessed giving an overall score range of 0-14. An excellent preparation would score 0-1; a good preparation, 2-4; while scores \>4 would indicate progressively worsening bowel preparations. A completely unprepared colon would score 11-14, depending on the amount of fluid. A simplified overall cleanliness score will be completed and compared to the Ottawa scale.
Scales provided to physician at time of colonoscopy, and filled out and collected after procedure is completed (1 hour time). Questionnaires are manually entered by an assistant into the study database on the same day as collection.
Secondary Outcomes (1)
Patient Satisfaction with preparation
Questionnaire given on day of pre-screen and collected on day of colonoscopy, approximately 3 weeks.Patients are not followed or contacted past the day of colonoscopy.
Study Arms (2)
PEG Arm
ACTIVE COMPARATORPatients randomized to this arm of the trial will be following preparation instructions using Polyethylene Glycol-Based Lavage in a split dose format
Pico-Salax + Bisacodyl Arm
ACTIVE COMPARATORPatients randomized to this arm will follow preparation instructions using Pico-Salax preparation plus Biscacodyl in a split dose format
Interventions
Split dose Polyethylene Glycol-Based Lavage (2L + 2L) If arrival for colonoscopy is prior to 10AM: at 12 noon on the day before your colonoscopy drink 2L of PEG within two hours. At 8PM that day, drink the remaining 2L of PEG within two hours. If arrival for colonoscopy is at or after 10AM: at 8PM on the day before your colonoscopy, drink 2L of PEG within two hours. Starting five hours before your arrival time at the Centre on the day of your colonoscopy, drink the remaining 2L of PEG within two hours.
If arrival for colonoscopy is prior to 10AM: 2 tablets Dulcolax at 8PM three days before colonoscopy, 2 tablets Dulcolax at 8PM two days before colonoscopy, and on the day before colonoscopy at 12 noon, drink the first packet of Pico-Salax in 8oz water, and the second packet of Pico-Salax in 8oz of water at 8PM. Day of colonoscopy, drink clear fluids. If arrival for colonoscopy is at or after 10AM: 2 tablets Dulcolax at 8PM three days before colonoscopy, 2 tablets Dulcolax at 8PM two days before colonoscopy, and on the day before colonoscopy at 8PM, drink the first packet of Pico-Salax in 8oz water. Day of colonoscopy, drink the second packet of Pico-Salax in 8oz water five hours before you are to arrive at the Centre.
Eligibility Criteria
You may not qualify if:
- Any history of kidney problems
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Foranzi & MacPhail Colon Cancer Screening Centre, Alberta Health Services
Calgary, Alberta, T2N 4Z6, Canada
Foranzi & MacPhail Colon Cancer Screening Centre
Calgary, Alberta, T2N 4Z6, Canada
Related Publications (1)
Rostom A, Dube C, Bishay K, Antonova L, Heitman SJ, Hilsden R. A randomized clinical prospective trial comparing split-dose picosulfate/ magnesium citrate and polyethylene glycol for colonoscopy preparation. PLoS One. 2019 Mar 28;14(3):e0211136. doi: 10.1371/journal.pone.0211136. eCollection 2019.
PMID: 30921345DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alaa Rostom, MD
University of Calgary Faculty of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD MSc FRCPC
Study Record Dates
First Submitted
August 5, 2011
First Posted
August 12, 2011
Study Start
May 1, 2011
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
May 31, 2012
Record last verified: 2012-05