Is blinding the endoscopists to bowel preparations in randomised controlled trials a reality?

ISRCTN	ISRCTN45620422
DOI	https://doi.org/10.1186/ISRCTN45620422
Protocol serial number	N/A
Sponsor	State University of New York at Buffalo (USA)
Funder	The office of graduate medical education at the State University of New York, Buffalo (USA)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Holger Schunemann
Scientific

Division of Clinical Research Development and Information Translation (INFORMA)
Italian National Cancer Institute/Istituto Regina Elena
Rome
-
Italy

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	PEG, NaP
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Oral sodium phosphate and polyethylene glycol
Primary outcome measure(s)	The primary outcome of this study is to determine the proportion of correct estimation of the bowel preparation by all endoscopists combined
Key secondary outcome measure(s)	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.
Completion date	25/08/2004

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	All
Target sample size at registration	114
Key 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
Key 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
Date of first enrolment	31/07/2003
Date of final enrolment	25/08/2004

Division of Clinical Research Development and Information Translation (INFORMA)

Rome
-
Italy

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2006		Yes	No