Colonoscopy Preparation Optimization for INpatients- COIN Study
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| First Received Date ICMJE | June 19, 2012 | ||||
| Last Updated Date | January 28, 2013 | ||||
| Start Date ICMJE | September 2012 | ||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01627171 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Colonoscopy Preparation Optimization for INpatients- COIN Study | ||||
| Official Title ICMJE | A Randomized Control Trial Comparing 4L PEGlyte to Regular Dose Pico-Salax and Split Dose Pico-Salax for Colonoscopy Bowel Preparation in Hospitalized Patients | ||||
| Brief Summary | 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 126 | ||||
| Estimated Completion Date | December 2013 | ||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01627171 | ||||
| Other Study ID Numbers ICMJE | RP 12-3657 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Khurram Khan, St. Joseph's Healthcare Hamilton | ||||
| Study Sponsor ICMJE | St. Joseph's Healthcare Hamilton | ||||
| Collaborators ICMJE | McMaster University | ||||
| Investigators ICMJE |
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| Information Provided By | St. Joseph's Healthcare Hamilton | ||||
| Verification Date | January 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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