Phase 4
N=480
Comparative Efficacy of Water & Indigo Carmine vs. Water or Air Method on Adenoma Detection Rate (ADR) - a Randomized Controlled Trial (RCT)
Colorectal Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT01607255 ↗Enrolled (actual)
480
Serious AEs
1.7%
Results posted
Jan 2019
Primary outcome: Primary: Number of Participants With Detected Proximal Diminutive (<10 mm) Adenoma Detection Rate — 86; 89; 83; 38 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Indigo carmine (Drug); water (exchange) method (Procedure); water (exchange) plus dye method (Procedure); air method (Procedure)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Detected Proximal Diminutive (<10 mm) Adenoma Detection Rate |
86; 89; 83; 38; 42; 18 | — |
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.
Eligibility Criteria
Inclusion Criteria
- asymptomatic Veterans scheduled for first time screening colonoscopy and agree to be randomized will be enrolled.
Exclusion Criteria
- patients who decline to be randomized, non screening cases.
Data sourced from ClinicalTrials.gov (NCT01607255). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.