Colonoscopy Preparation Optimization for INpatients- COIN Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by St. Joseph's Healthcare Hamilton
Sponsor:
Collaborator:
McMaster University
Information provided by (Responsible Party):
Khurram Khan, St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier:
NCT01627171
First received: June 19, 2012
Last updated: January 28, 2013
Last verified: January 2013

June 19, 2012
January 28, 2013
September 2012
December 2013   (final data collection date for primary outcome measure)
Ottawa Bowel Prep Score [ Time Frame: 30 minutes after procedure ] [ Designated as safety issue: No ]
Using a standardized, validated score for measuring quality of bowel preparation
Same as current
Complete list of historical versions of study NCT01627171 on ClinicalTrials.gov Archive Site
  • Procedures Cancelled or repeated due to inadequate bowel preparation [ Time Frame: During admission (average of 2 weeks) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Any adverse effects that may be attributed to the intervention
  • Tolerability of the preparation [ Time Frame: Within 1 day of intervention ] [ Designated as safety issue: No ]
    A questionnaire to assess the overall tolerability of the preparation.
Same as current
Not Provided
Not Provided
 
Colonoscopy Preparation Optimization for INpatients- COIN 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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
  • Endoscopy
  • Bowel Preparation Solutions
  • 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 Name: PEG-Lyte
  • Drug: Picosulfate sodium
    Two sachets, Each sachet has 10mg dose
    Other Name: Pico-Salax
  • Active Comparator: PEG Lyte
    PEGlyte to be reconstituted with 4L of water and taken in the evening before the colonoscopy.
    Interventions:
    • Drug: Bisacodyl 10mg
    • Drug: Polyethelene Glycol
  • Experimental: Pico Salax Split
    Two sachets of Pico-Salax with 1 taken the night before colonoscopy and the second taken the morning of colonoscopy.
    Interventions:
    • Drug: Bisacodyl 10mg
    • Drug: Picosulfate sodium
  • Experimental: Pico Salax Night Before
    2 sachets of Pico Salax mixed with water taken about 4 hours apart the night before colonoscopy
    Interventions:
    • Drug: Bisacodyl 10mg
    • Drug: Picosulfate sodium
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
126
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Lisa Balogh Melanson, BSc 905-522-1155 ext 33673 lbalogh@stjosham.on.ca
Canada
 
NCT01627171
RP 12-3657
No
Khurram Khan, St. Joseph's Healthcare Hamilton
St. Joseph's Healthcare Hamilton
McMaster University
Principal Investigator: Khurram J Khan, MD, BSc St Josephs
St. Joseph's Healthcare Hamilton
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP