Combined Chromoendoscopy and Water Method for Screening Colonoscopy

Not Applicable

Completed

• Conditions: Colon Polyp
• Interventions: Procedure: Water method and chromoendoscopy; Procedure: Water method

• Registration Number: NCT01383265
• Lead Sponsor: VA Northern California Health Care System

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.

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2011-06-24
• Study First Submitted QC: 2011-06-24
• Study First Posted: 2011-06-28
• Status Verified: 2013-06
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Last Update Submitted: 2013-06-13
• Last Update Posted: 2013-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1177

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Water method and chromoendoscopy	Water method and chromoendoscopy	Combined water method with chromoendoscopy using 0.008% IC solution for screening colonoscopy
Water method	Water method	Control method will use plain water with the water method for screening colonoscopy

Primary Outcome Measures

Name	Time	Method
Diagnosis of adenoma	24 months

Trial Locations

Locations (1)

Sacramento VA Medical Center; 🇺🇸 Mather, California, United States