Colorectal Neoplasms — Comparative Efficacy of Water & Indigo Carmine vs. Water or Air Method on Adenoma Detection Rate (ADR) - a Randomized Controlled Trial (RCT)
Leung FW, Leung JW, Siao-Salera RM, Mann SK, Jackson G The water method significantly enhances detection of diminutive lesions (adenoma and hyperplastic polyp combined) in the proximal colon in screening colonoscopy - data derived from two RCT in US veterans. J Interv Gastroenterol. 2011 Apr;1(2):48-52.
Leung JW, Thai A, Yen A, Ward G, Abramyan O, Lee J, Smith B, Leung F Magnetic endoscope imaging (ScopeGuide) elucidates the mechanism of action of the pain-alleviating impact of water exchange colonoscopy - attenuation of loop formation. J Interv Gastroenterol. 2012 Jul;2(3):142-146. Epub 2012 Jul 1.
Ngo C, Leung JW, Mann SK, Terrado C, Bowlus C, Ingram D, Leung FW Interim report of a randomized cross-over study comparing clinical performance of novice trainee endoscopists using conventional air insufflation versus warm water infusion colonoscopy. J Interv Gastroenterol. 2012 Jul;2(3):135-139. Epub 2012 Jul 1.
Yen AW, Leung JW, Leung FW A new method for screening and surveillance colonoscopy: Combined water-exchange and cap-assisted colonoscopy. J Interv Gastroenterol. 2012 Jul;2(3):114-119. Epub 2012 Jul 1.
Yen AW, Leung JW, Leung FW A novel method with significant impact on adenoma detection: combined water-exchange and cap-assisted colonoscopy. Gastrointest Endosc. 2013 Jun;77(6):944-8. doi: 10.1016/j.gie.2013.01.011. Epub 2013 Mar 6.
Comparative Efficacy of Water & Indigo Carmine vs Water or Air Method
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
