Colonoscopy Preparation Optimization for INpatients- COIN Study

Overview

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.

Full Title of Study: “A Randomized Control Trial Comparing 4L PEGlyte to Regular Dose Pico-Salax and Split Dose Pico-Salax for Colonoscopy Bowel Preparation in Hospitalized Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: December 2013

Interventions

  • 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
  • Drug: Picosulfate sodium
    • Two sachets, Each sachet has 10mg dose

Arms, Groups and Cohorts

  • Active Comparator: PEG Lyte
    • PEGlyte to be reconstituted with 4L of water and taken in the evening before the colonoscopy.
  • Experimental: Pico Salax Split
    • Two sachets of Pico-Salax with 1 taken the night before colonoscopy and the second taken the morning of colonoscopy.
  • Experimental: Pico Salax Night Before
    • 2 sachets of Pico Salax mixed with water taken about 4 hours apart the night before colonoscopy

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • St. Joseph’s Healthcare Hamilton
  • Collaborator
    • McMaster University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Khurram Khan, Assistant Professor of Medicine – St. Joseph’s Healthcare Hamilton
  • Overall Official(s)
    • Khurram J Khan, MD, BSc, Principal Investigator, St Josephs
  • Overall Contact(s)
    • Lisa Balogh Melanson, BSc, 905-522-1155, lbalogh@stjosham.on.ca

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