Clinical Trials Directory

Trials / Completed

CompletedNCT01383252

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
10 (actual)
Sponsor
VA Northern California Health Care System · Federal
Sex
All
Age
50 Years – 75 Years
Healthy volunteers
Not accepted

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

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREWater infusion in lieu of air insufflationAir 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.
PROCEDUREAir methodConventional 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.

Timeline

Start date
2010-02-01
Primary completion
2013-06-01
Completion
2013-06-01
First posted
2011-06-28
Last updated
2013-06-17

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01383252. Inclusion in this directory is not an endorsement.