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Unsedated Colonoscopy for Colorectal Cancer Screening and Surveillance

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ClinicalTrials.gov Identifier: NCT01383252
Recruitment Status : Completed
First Posted : June 28, 2011
Last Update Posted : June 17, 2013
Sponsor:
Information provided by (Responsible Party):
VA Northern California Health Care System

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:

  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

Condition or disease Intervention/treatment Phase
Colon Polyp Procedure: Water infusion in lieu of air insufflation Procedure: Air method Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Screening
Official Title: Comparison of Study Method Versus Conventional Method for Performing Unsedated Colonoscopy for Colorectal Cancer Screening and Surveillance
Study Start Date : February 2010
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Water method
Water infusion in lieu of air insufflation for screening and surveillance colonoscopy
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
Active Comparator: Air method
Air insufflation for screening and surveillance 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 Name: Screening colonoscopy



Primary Outcome Measures :
  1. Success of colonoscopy [ Time Frame: 24 months ]
    successful cecal intubation


Secondary Outcome Measures :
  1. Polyp detection [ Time Frame: 24 months ]
    Adenoma detection rate



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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01383252


Locations
United States, California
Sacramento VA Medical Center
Mather, California, United States, 95655
Sponsors and Collaborators
VA Northern California Health Care System
Investigators
Principal Investigator: Joseph Leung, MD Sacramento VA Medical Center

Publications:
Responsible Party: VA Northern California Health Care System
ClinicalTrials.gov Identifier: NCT01383252     History of Changes
Other Study ID Numbers: VANCHCS-GI-005
First Posted: June 28, 2011    Key Record Dates
Last Update Posted: June 17, 2013
Last Verified: June 2013

Keywords provided by VA Northern California Health Care System:
water method
air method
unsedated colonoscopy
adenoma detection

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases