Split Dose Pico-Salax + Bisacodyl vs. PEG Split Dose
Condition: Bowel Preparation for Colonoscopy
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): Polyethylene Glycol-Based Lavage; Pico-Salax (Magnesium Citrate) plus Bisacodyl
Intervention type(s): Drug; Drug
Intervention description(s): 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.
Other intervention name(s): Colyte; Pico-Salax or Magnesium Citrate; Bisacodyl is also known as Dulcolax.
Intervention MeSH terms: Bisacodyl; Magnesium citrate; Citric Acid; Sodium Citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Keywords: preoperative care; colonoscopy; cathartics