Colonoscopy Preparation Optimization for INpatients- COIN Study (COIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01627171
Recruitment Status : Unknown
Verified January 2013 by Khurram Khan, St. Joseph's Healthcare Hamilton.
Recruitment status was:  Recruiting
First Posted : June 25, 2012
Last Update Posted : January 30, 2013
McMaster University
Information provided by (Responsible Party):
Khurram Khan, St. Joseph's Healthcare Hamilton

June 19, 2012
June 25, 2012
January 30, 2013
September 2012
December 2013   (Final data collection date for primary outcome measure)
Ottawa Bowel Prep Score [ Time Frame: 30 minutes after procedure ]
Using a standardized, validated score for measuring quality of bowel preparation
Same as current
Complete list of historical versions of study NCT01627171 on Archive Site
  • 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.
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
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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.
    • 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.
    • 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
    • Drug: Bisacodyl 10mg
    • Drug: Picosulfate sodium
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
RP 12-3657
Not Provided
Not Provided
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