drugset / Trial / NCT01607255

Comparative Efficacy of Water & Indigo Carmine vs. Water or Air Method on Adenoma Detection Rate (ADR) - a Randomized Controlled Trial (RCT)

NCT01607255 ↗

Phase 4 Completed 480 enrolled VA Office of Research and Development
RandomizedParallel-groupSingle-blindTreatment

Summary

Adenoma detection rate (ADR) is a quality indicator of colonoscopy performed for colorectal cancer screening. Population studies have shown that traditional air colonoscopy fails to eliminate post screening colonoscopy cancers or cancer mortality in the proximal colon. The investigators aim to establish the superior effectiveness of combining chromoendoscopy with the water exchange method in detecting more proximal diminutive adenomas during screening colonoscopy in sedated Veterans. An improved adenoma detection rate associated with optical colonoscopy will minimize the risk of missed lesions. The improvement may translate into a remedy for the limitations of screening colonoscopy in the proximal colon, e.g. a higher adenoma detection rate may minimize the burden of post screening colonoscopy interval colorectal cancers among the veteran population.

Timeline

Start
2013-05-16
Primary completion
2017-06-30
Completion
2017-09-30

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject INDIGOTINDISULFONATE Small molecule 0.008 % —

Indications