Split Dose Pico-Salax + Bisacodyl vs. PEG Split Dose (BP)

University of Calgary

Status and phase: Completed; Phase 3

Conditions: Bowel Preparation for Colonoscopy

Treatments: Drug: Pico-Salax (Magnesium Citrate) plus Bisacodyl; Drug: Polyethylene Glycol-Based Lavage

Study type: Interventional

Funder types: Other

Identifiers

NCT01415687

23798

Details and patient eligibility

About

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.

Full 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.

Enrollment: 171 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

171 participants in 2 patient groups

PEG Arm

Active Comparator group

Description:

Patients randomized to this arm of the trial will be following preparation instructions using Polyethylene Glycol-Based Lavage in a split dose format

Treatment:

Drug: Polyethylene Glycol-Based Lavage

Pico-Salax + Bisacodyl Arm

Active Comparator group

Description:

Patients randomized to this arm will follow preparation instructions using Pico-Salax preparation plus Biscacodyl in a split dose format

Treatment:

Drug: Pico-Salax (Magnesium Citrate) plus Bisacodyl