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Unsedated Colonoscopy for Colorectal Cancer Screening and Surveillance

This study is currently recruiting participants.
Verified July 2011 by VA Northern California Health Care System
Sponsor:
Information provided by:
VA Northern California Health Care System
ClinicalTrials.gov Identifier:
NCT01383252
First received: June 21, 2011
Last updated: July 10, 2011
Last verified: July 2011
History of Changes

June 21, 2011
July 10, 2011
February 2010
November 2011   (final data collection date for primary outcome measure)
Success of colonoscopy [ Time Frame: 24 months ] [ Designated as safety issue: No ]
successful cecal intubation
successful cecal intubation [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01383252 on ClinicalTrials.gov Archive Site
Polyp detection [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Adenoma detection rate
adenoma detection rate [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Unsedated Colonoscopy for Colorectal Cancer Screening and Surveillance
Comparison of Study Method Versus Conventional Method for Performing Unsedated Colonoscopy for Colorectal Cancer Screening and Surveillance

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:

  1. Study method increases overall cecal intubation with comparable assessment of current experience and patient willingness to repeat future colonoscopy compared with conventional colonoscopy
  2. Study method improves bowel preparation and increases polyp pickup rate

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Screening
Colon Polyp
  • Procedure: Water infusion in lieu of air insufflation
    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.
    Other Names:
    • Water method
    • Screening colonoscopy
  • Procedure: Air method
    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.
    Other Names:
    • Air method
    • Screening colonoscopy
  • Experimental: Water method
    Water infusion in lieu of air insufflation for screening and surveillance colonoscopy
    Intervention: Procedure: Water infusion in lieu of air insufflation
  • Active Comparator: Air method
    Air insufflation for screening and surveillance colonoscopy
    Intervention: Procedure: Air method

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
March 2012
November 2011   (final data collection date for primary outcome measure)

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
Both
50 Years to 75 Years
No
Contact: Joseph Leung, MD 916-366-5339 Joseph.Leung2@va.gov
United States
 
NCT01383252
VANCHCS-GI-005
Yes
Lori Churby, VA Northern California Health Care System
VA Northern California Health Care System
Not Provided
Principal Investigator: Joseph Leung, MD Sacramento VA Medical Center
VA Northern California Health Care System
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP