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Combined Chromoendoscopy and Water Method for Screening Colonoscopy

Randomized Controlled Trial (RCT) to Compare Adenoma Detection Rate of Combined Chromoendoscopy (Indigo Carmine) With Water Infusion in Lieu of Air Insufflation (Water Method) vs. Water Method Alone in Screening Colonoscopy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01383265
Enrollment
1177
Registered
2011-06-28
Start date
2010-03-31
Completion date
2013-06-30
Last updated
2013-06-17

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

Conditions

Colon Polyp

Keywords

screening colonoscopy, adenoma, water method

Brief summary

In a RCT in screening colonoscopy subjects, we will determine if chromoendoscopy using a dilute solution of Indigocarmine (IC) delivered by the water method (study method) will improve adenoma detection rate compared with the water method with plain water alone (control method).

Detailed description

Background: Warm water infusion in lieu of air insufflation (water method) improves overall success of screening colonoscopy and our retrospective data indicate a higher adenoma detection rate. Dye spray methods to improve neoplastic polyp detection such as targeted staining or pancolonic chromoendoscopy have been described. Aim: In a RCT in screening colonoscopy subjects, we will determine if chromoendoscopy using a dilute solution of Indigocarmine (IC) delivered by the water method (study method) will improve adenoma detection rate compared with the water method with plain water alone (control method). Methods: After informed consent patients undergoing screening colonoscopy will be randomized to be examined by the study or control method. Study method will employ a 0.008% IC solution. Control method will employ plain water. The water method in both study and control groups will be applied as previously described. The colonoscopy will be performed under sedation. Primary outcome measure: adenoma detection rate; secondary outcome: relevant procedure-related variables.

Interventions

PROCEDUREWater method and chromoendoscopy

Study method will employ a 0.008% IC solution used with the water method for screening colonoscopy

PROCEDUREWater method

Control method will use plain water with water method for screening colonoscopy

Sponsors

VA Northern California Health Care System
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Adult (≥50 years old * Male and female patients * Scheduled for screening colonoscopy * Consented and accept randomization to study or control method

Exclusion criteria

* Patients who decline to participate * Unable to give informed consent * Unable to complete questionnaires due to language or other difficulties

Design outcomes

Primary

MeasureTime frame
Diagnosis of adenoma24 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026