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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN45620422
Enrollment
114
Registered
2005-10-11
Start date
2003-07-31
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonoscopy for screening, surveillance, or diagnosis of colorectal cancer Surgery

Interventions

Blinding the colonoscopists to the type of bowel preparation given prior to colonoscopy - oral sodium phosphate versus polyethylene glycol

Sponsors

State University of New York at Buffalo (USA)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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 (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

Design outcomes

Primary

MeasureTime frame
The primary outcome of this study is to determine the proportion of correct estimation of the bowel preparation by all endoscopists combined

Secondary

MeasureTime frame
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.

Countries

United States of America

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026