Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
PEG, NaP
Study hypothesis
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
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Condition
Colonoscopy for screening, surveillance, or diagnosis of colorectal cancer
Intervention
Blinding the colonoscopists to the type of bowel preparation given prior to colonoscopy - oral sodium phosphate versus polyethylene glycol
Intervention type
Drug
Phase
Not Specified
Drug names
Oral sodium phosphate and polyethylene glycol
Primary outcome measure
The primary outcome of this study is to determine the proportion of correct estimation of the bowel preparation by all endoscopists combined
Secondary outcome measures
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.
Overall trial start date
31/07/2003
Overall trial end date
25/08/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
114 patients
Participant exclusion criteria
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
Recruitment start date
31/07/2003
Recruitment end date
25/08/2004
Locations
Countries of recruitment
United States of America
Trial participating centre
Division of Clinical Research Development and Information Translation (INFORMA)
Rome
-
Italy
Sponsor information
Organisation
State University of New York at Buffalo (USA)
Sponsor details
The Office of Graduate Medical Education
117 Cary hall
3435 Main street
Buffalo
14214
United States of America
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
The office of graduate medical education at the State University of New York, Buffalo (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17113722
Publication citations
-
Results
El-Dika S, Mahl T, Mehboob S, Miqdadi J, Heels-Ansdell D, Handley B, Sitrin M, Schünemann H, Is blinding the endoscopists to bowel preparations in randomized-controlled trials a reality?, Cancer Detect. Prev., 2006, 30, 6, 552-559, doi: 10.1016/j.cdp.2006.10.004.