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OpenTrials
Completed

NCT Number: NCT01383265

Combined Chromoendoscopy and Water Method for 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).

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Key information

Conditions

Colon Polyp Adenoma Colonic Polyps Intestinal Polyps Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sacramento VA Medical Center

Mather, California, 95655, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Water method and chromoendoscopy

Procedure

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

Other names: Water method, Chromoendoscopy, Screening colonoscopy

Water method

Procedure

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

Other names: Screening colonoscopy

Primary outcomes

  1. Diagnosis of adenoma

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

VA Northern California Health Care System

Fed

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jun 28, 2011
Registry last updated
Jun 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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