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ISRCTN
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ISRCTN45620422
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ClinicalTrials.gov identifier
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Public title
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Is blinding the endoscopists to bowel preparations in randomised controlled trials a reality?
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Scientific title
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Acronym
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PEG, NaP
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Serial number at source
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N/A
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Study hypothesis
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The primary aim of this study was to explore whether endoscopists can be effectively blinded to the type of bowel preparation in the trials that compare the cleaning efficacy of oral sodium phosphate and polyethylene glycol
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Lay summary
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United States of America
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Disease/condition/study domain
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Colonoscopy for screening, surveillance, or diagnosis of colorectal cancer
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Participants - inclusion criteria
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All outpatient adults (18-65 years old) undergoing colonoscopy for screening, surveillance, or diagnosis of colorectal cancer at the Western NY Veterans Affairs Medical Center in Buffalo between May 2003 and August 2004 who had a basic metabolic profile blood test within one year prior to enrollment were eligible for this study
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Participants - exclusion criteria
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Patients were not eligible for the study if any of the following was present:
1. Evidence of renal insufficiency (creatinine >2.0 mg/dl)
2. Evidence of electrolyte abnormalities
3. Cardiovascular disease, including uncontrolled congestive heart failure (American Heart Association Functional Class III or IV), unstable angina, or myocardial infarction, percutaneous transluminal coronary angioplasty, cardiac surgery within the past 3 months
4. Inflammatory bowel disease
5. Colon disease, including chronic constipation (<2 bowel movements per week for >one year, ileus and/or acute obstruction, hypomotility syndrome, megacolon, idiopathic pseudo-obstruction, or previous colonic surgery
6. Pregnant or breastfeeding female
A meta-analysis that included randomised controlled trials comparing the two bowel preparations showed that clinical adverse effects were comparable in frequency when patients are carefully selected
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Anticipated start date
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31/07/2003
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Anticipated end date
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25/08/2004
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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114 patients
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Interventions
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Blinding the colonoscopists to the type of bowel preparation given prior to colonoscopy - oral sodium phosphate versus polyethylene glycol
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Primary outcome measure(s)
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The primary outcome of this study is to determine the proportion of correct estimation of the bowel preparation by all endoscopists combined
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Secondary outcome measure(s)
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Secondary outcomes are the proportion of correct estimations by individual endoscopists. We are also interested in the distinguishing features that endoscopists reported as reasons for their judgments. Other secondary aims are the comparison of tolerability, safety, and overall quality of colon cleansing for the two bowel preparations.
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Sources of funding
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The office of graduate medical education at the State University of New York, Buffalo (USA)
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Trial website
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Publications
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2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17113722
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Contact name
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Dr
Holger
Schunemann
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Address
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Division of Clinical Research Development and Information Translation (INFORMA)
Italian National Cancer Institute/Istituto Regina Elena
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City/town
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Rome
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Zip/Postcode
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-
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Country
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Italy
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Sponsor
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State University of New York at Buffalo (USA)
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Address
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The Office of Graduate Medical Education
117 Cary hall
3435 Main street
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City/town
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Buffalo
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Zip/Postcode
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14214
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Country
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United States of America
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Sponsor website:
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http://www.smbs.buffalo.edu/gme/
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Date applied
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23/09/2005
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Last edited
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16/08/2011
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Date ISRCTN assigned
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11/10/2005
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