Unsedated Colonoscopy for Colorectal Cancer Screening and Surveillance
Primary Purpose
Colon Polyp
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Water infusion in lieu of air insufflation
Air method
Sponsored by

About this trial
This is an interventional screening trial for Colon Polyp focused on measuring water method, air method, unsedated colonoscopy, adenoma detection
Eligibility Criteria
Inclusion Criteria:
- Adult (>50 years old)
- Male and female patients
- Scheduled and consented for screening or surveillance colonoscopy without medications
- Accept randomization to the study or the conventional method
- Agree to complete study questionnaires
- The adults will be normal healthy patients or patients with mild systemic disease, ASA 1 or ASA 2.
Exclusion Criteria:
- Patients who decline to participate
- Unable to give informed consent or complete the 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
Air method
Arm Description
Water infusion in lieu of air insufflation for screening and surveillance colonoscopy
Air insufflation for screening and surveillance colonoscopy
Outcomes
Primary Outcome Measures
Success of colonoscopy
successful cecal intubation
Secondary Outcome Measures
Polyp detection
Adenoma detection rate
Full Information
NCT ID
NCT01383252
First Posted
June 21, 2011
Last Updated
June 13, 2013
Sponsor
VA Northern California Health Care System
1. Study Identification
Unique Protocol Identification Number
NCT01383252
Brief Title
Unsedated Colonoscopy for Colorectal Cancer Screening and Surveillance
Official Title
Comparison of Study Method Versus Conventional Method for Performing Unsedated Colonoscopy for Colorectal Cancer Screening and Surveillance
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
February 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
Yes
5. Study Description
Brief Summary
In a prospective, randomized, controlled study, two methods (water method vs. air method) of performing colonoscopy will be compared in patients undergoing unsedated colonoscopy for CRC screening. The investigators hypothesize that:
Study method increases overall cecal intubation with comparable assessment of current experience and patient willingness to repeat future colonoscopy compared with conventional colonoscopy
Study method improves bowel preparation and increases polyp pickup rate
Detailed Description
Colorectal cancer (CRC) screening for the high and the low risk healthy asymptomatic Veterans Affairs (VA) patients is being promoted. Compliance with this Directive will result in an increased number of VA patients undergoing colonoscopy.
The demand for colonoscopy far exceeds the capacity available to perform the procedure in the VA system. The conventional practice for colonoscopy at VA facilities across the country is to perform colonoscopy under conscious sedation with air insufflation. Efficiency is governed by the fact that sedated patients require time and space for recovery and these are major limiting factors in the current setting for the use of colonoscopy for CRC screening.
In a prospective, randomized, controlled trial (RCT), two methods of performing colonoscopy will be compared in patients undergoing unsedated colonoscopy for CRC screening. We compared the water infusion in lieu of air insufflation (water method) with the conventional air insufflation method. We hypothesize that the water method (Study method) increases overall cecal intubation with comparable assessment of current experience and patient willingness to repeat future colonoscopy compared with conventional colonoscopy. In addition, the water method improves bowel preparation and increases polyp pickup rate.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Polyp
Keywords
water method, air method, unsedated colonoscopy, adenoma detection
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Water method
Arm Type
Experimental
Arm Description
Water infusion in lieu of air insufflation for screening and surveillance colonoscopy
Arm Title
Air method
Arm Type
Active Comparator
Arm Description
Air insufflation for screening and surveillance colonoscopy
Intervention Type
Procedure
Intervention Name(s)
Water infusion in lieu of air insufflation
Other Intervention Name(s)
Water method, Screening colonoscopy
Intervention Description
Air pump is turned off, water is infused using a peristaltic pump to aid colonoscope insertion until the cecum is reached. Air pockets and dirty water are suctioned before clean water is infused (exchange) to facilitate scope insertion.
Intervention Type
Procedure
Intervention Name(s)
Air method
Other Intervention Name(s)
Screening colonoscopy
Intervention Description
Conventional air method with minimal insufflation of air to aid scope insertion until the cecum is reached. Water in aliquots will be used for irrigation and cleansing.
Primary Outcome Measure Information:
Title
Success of colonoscopy
Description
successful cecal intubation
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Polyp detection
Description
Adenoma detection rate
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 and consented for screening or surveillance colonoscopy without medications
Accept randomization to the study or the conventional method
Agree to complete study questionnaires
The adults will be normal healthy patients or patients with mild systemic disease, ASA 1 or ASA 2.
Exclusion Criteria:
Patients who decline to participate
Unable to give informed consent or complete the 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
17661766
Citation
Leung JW, Mann S, Leung FW. Options for screening colonoscopy without sedation: a pilot study in United States veterans. Aliment Pharmacol Ther. 2007 Aug 15;26(4):627-31. doi: 10.1111/j.1365-2036.2007.03404.x.
Results Reference
background
PubMed Identifier
18279868
Citation
Leung FW, Mann SK, Salera R, Toomsen L, Cabrera H, Prather D, Gutierrez R, Leung JW. Options for screening colonoscopy without sedation: sequel to a pilot study in U.S. veterans. Gastrointest Endosc. 2008 Apr;67(4):712-7. doi: 10.1016/j.gie.2007.10.028. Epub 2008 Feb 14.
Results Reference
background
PubMed Identifier
19058003
Citation
Leung JW, Salera R, Toomsen L, Mann S, Leung FW. Pilot feasibility study of the method of water infusion without air insufflation in sedated colonoscopy. Dig Dis Sci. 2009 Sep;54(9):1997-2001. doi: 10.1007/s10620-008-0576-4. Epub 2008 Dec 5.
Results Reference
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Unsedated Colonoscopy for Colorectal Cancer Screening and Surveillance
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