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Comparison of Study Method Versus Conventional Method for Performing Unsedated Colonoscopy for Colorectal Cancer Screening and Surveillance

50 Years
75 Years
Not Enrolling
Colon Polyp

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Trial Information

Comparison of Study Method Versus Conventional Method for Performing Unsedated Colonoscopy for Colorectal Cancer Screening and Surveillance

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Screening

Outcome Measure:

Success of colonoscopy

Outcome Description:

successful cecal intubation

Outcome Time Frame:

24 months

Safety Issue:


Principal Investigator

Joseph Leung, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sacramento VA Medical Center


United States: Federal Government

Study ID:




Start Date:

February 2010

Completion Date:

June 2013

Related Keywords:

  • Colon Polyp
  • water method
  • air method
  • unsedated colonoscopy
  • adenoma detection
  • Colonic Polyps
  • Colorectal Neoplasms



Sacramento VA Medical CenterMather, California  95655