Combined Chromoendoscopy and Water Method for Screening Colonoscopy

Study Overview
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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).

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.

Official Title
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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

Conditions
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Colon Polyp

Intervention / Treatment
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* Procedure: Water method and chromoendoscopy
* Procedure: Water method


Participation Criteria
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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 Exclusion Criteria: Patients who decline to participate Unable to give informed consent Unable to complete questionnaires due to language or other difficulties

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Water method and chromoendoscopy<br>Combined water method with chromoendoscopy using 0.008% IC solution for screening colonoscopy | Procedure: Water method and chromoendoscopy<br>* Study method will employ a 0.008% IC solution used with the water method for screening colonoscopy<br>* Other names: Screening colonoscopy;|
| Active Comparator: Water method<br>Control method will use plain water with the water method for screening colonoscopy | Procedure: Water method<br>* Control method will use plain water with water method for screening colonoscopy<br>* Other names: Screening colonoscopy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis of adenoma |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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screening colonoscopy, adenoma, water method