Combined Chromoendoscopy and Water Method for Screening Colonoscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1177 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2013-06-30

Brief Summary

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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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Detailed Description

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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

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Colon Polyp

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Participants

Study Groups

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Water method and chromoendoscopy

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

Group Type EXPERIMENTAL

Water method and chromoendoscopy

Intervention Type PROCEDURE

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

Water method

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

Group Type ACTIVE_COMPARATOR

Water method

Intervention Type PROCEDURE

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

Interventions

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Water method and chromoendoscopy

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

Intervention Type PROCEDURE

Water method

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

Intervention Type PROCEDURE

Other Intervention Names

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Water method Chromoendoscopy Screening colonoscopy Screening colonoscopy

Eligibility Criteria

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Inclusion Criteria

* Adult (≥50 years old
* Male and female patients
* Scheduled for screening colonoscopy
* Consented and accept randomization to study or control method