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

NCT ID: NCT02070341

Last Updated: 2015-09-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2014-07-31

Brief Summary

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.

Conditions

Bowel Preparation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Polyethylene Glycol

Intervention Type: DRUG

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.

Group Type: EXPERIMENTAL

Picosalax

Intervention Type: DRUG

Interventions

Polyethylene Glycol

Intervention Type: DRUG

Picosalax

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Queen's University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Lawrence Hookey

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lawrence Hookey

Role: PRINCIPAL_INVESTIGATOR

Queen's University

Stephen Vanner

Role: PRINCIPAL_INVESTIGATOR

Queen's University

Locations

Hotel Dieu Hospital

Kingston, Ontario, Canada

Countries

Canada

Other Identifiers

Hookey Picosalax PEG

Identifier Type: -

Identifier Source: org_study_id