Clinical Trials Directory

Trials / Unknown

UnknownNCT00920751

Comparison of on Demand Sedation With Study Method Versus on Demand Sedation With Conventional Method for Performing Colonoscopy for Colorectal Cancer Screening and Surveillance

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
100 (estimated)
Sponsor
East Bay Institute for Research and Education · Academic / Other
Sex
All
Age
50 Years – 80 Years
Healthy volunteers
Accepted

Summary

Hypothesis 1. Study method achieves lower requirement for medications 2. Study method increases overall cecal intubation with comparable assessment of current experience and patient willingness to repeat future colonoscopy compared with conventional colonoscopy 3. Study method results in reduction in medication-related (cardiorespiratory) complications, faster turn around of patients, compared with conventional colonoscopy 4. Study method improves bowel preparation and increases polyp pickup rate Colorectal cancer (CRC) screening for the high and the low risk healthy asymptomatic VA patients is being promoted (VHA directive). 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. Methods that maintain a high success rate and good patient assessment improve overall compliance for surveillance colonoscopy. Our preliminary experience showed that patients are able to complete successful colonoscopy without sedation in 52% of cases when colonoscopy was aided by a water infusion in lieu of air insufflation method. In this group of patients, the shortened recovery time means a quick turn around of patient and a more efficient endoscopy service. Patients are able to communicate better with the staff and physician regarding their problem and discharge instructions, and not subjected to the amnesic effect of sedation. Next day follow-up of patient by telephone contact which requires commitment of staff time can be obviated. If this randomized study confirms the success of our preliminary findings and this technique is adopted by more endoscopists, a larger number of VA patients may benefit from less sedation complications and at the same time allow for more efficient colonoscopy screening services.

Conditions

Interventions

TypeNameDescription
PROCEDUREWater infusionWater infusion in lieu of air insufflation during colonoscope insertion
PROCEDUREAir insufflationConventional air insufflation colonoscopy

Timeline

Start date
2009-03-01
First posted
2009-06-15
Last updated
2009-06-15

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00920751. Inclusion in this directory is not an endorsement.