NCT01383265

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,177 (actual)
• Sponsor: VA Northern California Health Care System · Federal
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colon Polyp

Interventions

Type	Name	Description
PROCEDURE	Water method and chromoendoscopy	Study method will employ a 0.008% IC solution used with the water method for screening colonoscopy
PROCEDURE	Water method	Control method will use plain water with water method for screening colonoscopy

Timeline

• Start date: 2010-03-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2011-06-28
• Last updated: 2013-06-17

Locations

1 site across 1 country: United States