Patient Tolerability and Efficacy of Bowel Preparation With Split Dose Picosalax vs. Split Dose PEG

A Randomized Controlled Trial Examining Patient Tolerability and Efficacy of Bowel Preparation With Split Dose Picosalax vs. Split Dose Polyethylene Glycol

Introduction: Colonoscopy is an important tool for colon cancer screening. Proper colon cleansing is essential to ensure adequate mucosal examination. Timing of bowel preparation administration is now recognized as an important component for achieving superior cleansing. Multiple randomized controlled trials and meta-analyses have found split-dosing to be superior than day-before dosing. Objective: This study aims to compare two types of bowel preparations in split-doses to assess for differences in patient tolerability, as well as efficacy of colon cleansing. Methods: This is a prospective, single-blinded, randomized-controlled trial. Patients who are being referred for a colonoscopy will be recruited to participate in the study. They will be randomly assigned to receive either a split-dose polyethylene glycol (PEG) or picosalax (P/MC) bowel preparation. Patient tolerability will be examined through questionnaires. The endoscopist performing the colonoscopy will use two standardized bowel preparation scoring systems to evaluate the quality of the cleansing. The investigators propose that P/MC will be superior to PEG in patient tolerability and non-inferior in bowel cleansing effects.

Study Overview

• Status: Terminated
• Conditions: Bowel Preparation
• Intervention / Treatment: Drug: Polyethylene Glycol; Drug: Picosalax

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L5G2
      • Hôtel Dieu Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All male and non-pregnant female patients between ages 18 and 75 years old who require outpatient colonoscopy

Exclusion Criteria:

• ileus or bowel obstruction, previous colorectal surgery, ascites, recognized renal impairment, defined as GFR less than normal in 3 months prior to enrollment, active inflammatory bowel disease, insulin dependent diabetes, pregnancy, or recent (<6 months) myocardial infarction or unstable angina

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Split dose PEG; Patients randomized to the Polyethylene Glycol (PEG) group will be instructed to ingest 2L of bowel preparation the night before their colonoscopy (starting at 7PM), as well as 1.5-2L of carbohydrate-electrolyte rehydration solution. The following day they will be instructed to ingest the remaining 2L of bowel preparation and must finish ingesting the entire preparation at least 4 hours prior to the scheduled colonoscopy.	Drug: Polyethylene Glycol
EXPERIMENTAL: Split dose Picosalax; Patients randomized to the Picosalax (P/MC) group will be instructed to mix one sachet in 150mL of water and ingest the entire mixture at 7PM the night before their colonoscopy. In addition, they will be instructed to ingest 1.5-2L of carbohydrate-electrolyte rehydration solution after they consume the P/MC sachet. The following day they will mix the second sachet in 150mL of water and must finish ingesting the entire preparation at least 4 hours prior to the scheduled colonoscopy. They will also be instructed to drink additional carbohydrate-electrolyte rehydration solution after they ingest the P/MC sachet.	Drug: Picosalax

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient tolerability	Patients will be asked to complete a questionnaire to assess ease of completion and symptoms. Questionnaire items are weighted on a 5-point Likert scale. Interference with sleep will be assessed through a questionnaire that is based on a modified validated sleep questionnaire (St. Mary's Hospital Sleep Questionnaire). Participants will be asked to complete this questionnaire at the initial appointment and again on the day of their procedure	Two days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of bowel preparation	The colonoscopist will be blinded to the type of preparation the subject underwent. The colonoscopist will complete a validated questionnaire to assess the quality of the preparation (The Ottawa Scale) and the 4-point Aronchick bowel cleansing scale. The patient's baseline bowel habit will be recorded, as well as the withdrawal time, volume of liquid suctioned and volume of washing fluid used during the colonoscopy.	During colonoscopy

Collaborators and Investigators

• Sponsor: Queen's University
• Investigators: Principal Investigator: Stephen Vanner, Queen's University

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (ACTUAL): July 1, 2014
• Study Completion (ACTUAL): July 1, 2014

Study Registration Dates

• First Submitted: February 20, 2014
• First Submitted That Met QC Criteria: February 24, 2014
• First Posted (ESTIMATE): February 25, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): September 28, 2015
• Last Update Submitted That Met QC Criteria: September 25, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: quality; patient tolerability
• Other Study ID Numbers: Hookey Picosalax PEG