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Combined Chromoendoscopy and Water Method for Screening Colonoscopy

Primary Purpose

Colon Polyp

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Water method and chromoendoscopy
Water method
Sponsored by
VA Northern California Health Care System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colon Polyp focused on measuring screening colonoscopy, adenoma, water method

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sacramento VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Water method and chromoendoscopy

Water method

Arm Description

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

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

Outcomes

Primary Outcome Measures

Diagnosis of adenoma

Secondary Outcome Measures

Full Information

First Posted
June 24, 2011
Last Updated
June 13, 2013
Sponsor
VA Northern California Health Care System
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1. Study Identification

Unique Protocol Identification Number
NCT01383265
Brief Title
Combined Chromoendoscopy and Water Method for Screening Colonoscopy
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Northern California Health Care System

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Polyp
Keywords
screening colonoscopy, adenoma, water method

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1177 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Water method and chromoendoscopy
Arm Type
Experimental
Arm Description
Combined water method with chromoendoscopy using 0.008% IC solution for screening colonoscopy
Arm Title
Water method
Arm Type
Active Comparator
Arm Description
Control method will use plain water with the water method for screening colonoscopy
Intervention Type
Procedure
Intervention Name(s)
Water method and chromoendoscopy
Other Intervention Name(s)
Water method, Chromoendoscopy, Screening colonoscopy
Intervention Description
Study method will employ a 0.008% IC solution used with the water method for screening colonoscopy
Intervention Type
Procedure
Intervention Name(s)
Water method
Other Intervention Name(s)
Screening colonoscopy
Intervention Description
Control method will use plain water with water method for screening colonoscopy
Primary Outcome Measure Information:
Title
Diagnosis of adenoma
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Leung, MD
Organizational Affiliation
Sacramento VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sacramento VA Medical Center
City
Mather
State/Province
California
ZIP/Postal Code
95655
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19555938
Citation
Leung JW, Mann SK, Siao-Salera R, Ransibrahmanakul K, Lim B, Cabrera H, Canete W, Barredo P, Gutierrez R, Leung FW. A randomized, controlled comparison of warm water infusion in lieu of air insufflation versus air insufflation for aiding colonoscopy insertion in sedated patients undergoing colorectal cancer screening and surveillance. Gastrointest Endosc. 2009 Sep;70(3):505-10. doi: 10.1016/j.gie.2008.12.253. Epub 2009 Jun 24.
Results Reference
background
PubMed Identifier
21184876
Citation
Leung J, Mann S, Siao-Salera R, Ransibrahmanakul K, Lim B, Canete W, Samson L, Gutierrez R, Leung FW. A randomized, controlled trial to confirm the beneficial effects of the water method on U.S. veterans undergoing colonoscopy with the option of on-demand sedation. Gastrointest Endosc. 2011 Jan;73(1):103-10. doi: 10.1016/j.gie.2010.09.020.
Results Reference
background
PubMed Identifier
23805387
Citation
Leung J, Mann S, Siao-Salera R, Ngo C, McCreery R, Canete W, Leung F. Indigocarmine added to the water exchange method enhances adenoma detection - a RCT. J Interv Gastroenterol. 2012 Jul;2(3):106-111. doi: 10.4161/jig.23728. Epub 2012 Jul 1.
Results Reference
derived

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Combined Chromoendoscopy and Water Method for Screening Colonoscopy

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