Colonoscopy Preparation Optimization for INpatients- COIN Study (COIN)

A Randomized Control Trial Comparing 4L PEGlyte to Regular Dose Pico-Salax and Split Dose Pico-Salax for Colonoscopy Bowel Preparation in Hospitalized Patients

Colonoscopic examinations are performed routinely in hospitalized patients for a variety of indications. However, numerous limitations exist in hospitalized patients preventing an endoscopist from performing high quality examinations; possibly necessitating repeated procedures leading to increased cost and re-exposure to their inherent risks. One such prominent challenge lays in the adequacy of bowel cleansing. Inpatient status has been shown to be a predictor of poor bowel preparation as these patients are older, less mobile and have more co morbidities than the outpatient population. Currently, no standardized (or optimized) bowel preparation type or regimen for administration exists for the hospital inpatient population undergoing colonoscopy. Studies in the outpatient population have demonstrated that timing and choice of cathartic medication effects the cleanliness of the bowel preparation but there is no such clinical evidence for in-patients who receive whatever cathartic agent is on hospital formulary. The purpose of the study is compare efficacy, patient satisfaction, and adverse effects associated with low volume cathartic (Pico-Salax) to the current standard volume 4 liter (PEG-Lyte) and the effect of alternate timing of dosages.

Study Overview

• Status: Unknown
• Conditions: Endoscopy; Bowel Preparation Solutions
• Intervention / Treatment: Drug: Bisacodyl 10mg; Drug: Polyethelene Glycol; Drug: Picosulfate sodium

• Study Type: Interventional
• Enrollment (Anticipated): 126
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Lisa Balogh Melanson, BSc; Phone Number: 33673 905-522-1155; Email: lbalogh@stjosham.on.ca

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N4A6
      • Recruiting
      • St Joseph Hospital
      • Contact: Lisa Balogh-Melanson, BSc; Phone Number: 33673 905-522-1155; Email: lbalogh@stjosham.on.ca
      • Principal Investigator: Khurram J Khan, MD,BSc
      • Sub-Investigator: David Morgan, MD, MSc
      • Sub-Investigator: Robert Spaziani, MD
      • Sub-Investigator: Subhas Ganguli, MD, MSc
      • Sub-Investigator: Keith Tsoi, MD
      • Sub-Investigator: Subash Jalali, MBBS
      • Sub-Investigator: Houssein Fergani, MD
      • Sub-Investigator: Abbas Merali, MD
      • Sub-Investigator: Nauzer Forbes, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Inpatient colonoscopy
• Age greater than 18 years old
• Able to give consent

Exclusion Criteria:

• No consent obtained
• Pregnancy or lactating
• Renal impairment
• Severe CHF (NYHA class 3/4)
• Recent myocardial infarction (preceding 6 months)
• Ileus
• Ascites
• Severe Colitis
• Toxic Megacolon
• Gastrointestinal Obstruction
• PEG tube
• Previous large bowel resection
• Allergy to study drug

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PEG Lyte; PEGlyte to be reconstituted with 4L of water and taken in the evening before the colonoscopy.	Drug: Bisacodyl 10mg; Given at the start of the bowel preparation the day before colonoscopy; Drug: Polyethelene Glycol; 280g reconstituted in 4 liters of water; Other Names: PEG-Lyte
Experimental: Pico Salax Split; Two sachets of Pico-Salax with 1 taken the night before colonoscopy and the second taken the morning of colonoscopy.	Drug: Bisacodyl 10mg; Given at the start of the bowel preparation the day before colonoscopy; Drug: Picosulfate sodium; Two sachets, Each sachet has 10mg dose; Other Names: Pico-Salax
Experimental: Pico Salax Night Before; 2 sachets of Pico Salax mixed with water taken about 4 hours apart the night before colonoscopy	Drug: Bisacodyl 10mg; Given at the start of the bowel preparation the day before colonoscopy; Drug: Picosulfate sodium; Two sachets, Each sachet has 10mg dose; Other Names: Pico-Salax

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ottawa Bowel Prep Score	Using a standardized, validated score for measuring quality of bowel preparation	30 minutes after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedures Cancelled or repeated due to inadequate bowel preparation	If bowel preparation is deemed inadequate to the point the procedure must be cancelled or rescheduled	During admission (average of 2 weeks)
Individual Components of Ottawa Bowel Prep Score	Each section of prep score evaluating the right, mid, and left colon, as well as the fluid score will be analyzed individually	30 minutes after procedure
Adverse Effects	Any adverse effects that may be attributed to the intervention	Up to 48 hours after procedure
Tolerability of the preparation	A questionnaire to assess the overall tolerability of the preparation.	Within 1 day of intervention

Collaborators and Investigators

• Sponsor: St. Joseph's Healthcare Hamilton
• Collaborators: McMaster University
• Investigators: Principal Investigator: Khurram J Khan, MD, BSc, St Josephs

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: June 19, 2012
• First Submitted That Met QC Criteria: June 22, 2012
• First Posted (Estimate): June 25, 2012

Study Record Updates

• Last Update Posted (Estimate): January 30, 2013
• Last Update Submitted That Met QC Criteria: January 28, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gastrointestinal Agents; Cathartics; Laxatives; Bisacodyl; Picosulfate sodium
• Other Study ID Numbers: RP 12-3657

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No