Combined Chromoendoscopy and Water Method for Screening Colonoscopy

June 13, 2013 updated by: VA Northern California Health Care System

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1177

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Mather, California, United States, 95655
        • Sacramento VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Water method and chromoendoscopy
Combined water method with chromoendoscopy using 0.008% IC solution for screening colonoscopy
Procedure: Water method and chromoendoscopy
Study method will employ a 0.008% IC solution used with the water method for screening colonoscopy
Other Names:
  • Water method
  • Screening colonoscopy
  • Chromoendoscopy
Active Comparator: Water method
Control method will use plain water with the water method for screening colonoscopy
Procedure: Water method
Control method will use plain water with water method for screening colonoscopy
Other Names:
  • Screening colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Diagnosis of adenoma
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Northern California Health Care System

Investigators

  • Principal Investigator: Joseph Leung, MD, Sacramento VA Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

June 24, 2011

First Submitted That Met QC Criteria

June 24, 2011

First Posted (Estimate)

June 28, 2011

Study Record Updates

Last Update Posted (Estimate)

June 17, 2013

Last Update Submitted That Met QC Criteria

June 13, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VANCHCS-GI-006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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