Clinical trial NCT01415687: Split Dose Pico-Salax + Bisacodyl vs. PEG Split Dose
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bowel Preparation for Colonoscopy
Keywords: preoperative care
colonoscopy
cathartics
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2011-08-12
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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 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

Primary outcomes:
measure: Quality of Bowel Cleanliness
timeFrame: 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:
measure: Patient Satisfaction with preparation
timeFrame: 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.
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foranzi & MacPhail Colon Cancer Screening Centre, Alberta Health Services
state: Alberta
city: Calgary
country: Canada
facility: Foranzi & MacPhail Colon Cancer Screening Centre
state: Alberta
Study officials:
affiliation: University of Calgary Faculty of Medicine
name: Alaa Rostom, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.