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

Completed

• Conditions: Colonoscopy for screening, surveillance, or diagnosis of colorectal cancer; Surgery

• Registration Number: ISRCTN45620422
• Lead Sponsor: State University of New York at Buffalo (USA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10-11
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 114

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified