Combined Chromoendoscopy and Water Method for Screening Colonoscopy

VA Northern California Health Care System

Status: Completed

Conditions: Colon Polyp

Treatments: Procedure: Water method and chromoendoscopy; Procedure: Water method

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01383265

VANCHCS-GI-006

Details and patient eligibility

About

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).

Full 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.

Enrollment: 1,177 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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1,177 participants in 2 patient groups

Water method and chromoendoscopy

Experimental group

Description:

Combined water method with chromoendoscopy using 0.008% IC solution for screening colonoscopy

Treatment:

Procedure: Water method and chromoendoscopy

Water method

Active Comparator group

Description:

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

Treatment:

Procedure: Water method