View Clinical Trial (Medical Research Study)
Comparison of on Demand Sedation With Study Method Versus on Demand Sedation With Conventional Method for Performing Colonoscopy for Colorectal Cancer Screening and Surveillance
| City: |
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Mather |
| State: |
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California |
| Zip Code: |
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95655 |
| Conditions: |
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Colorectal Cancer Screening |
| Purpose: |
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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.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- Adult (> 50 years old), male and female patients
- Scheduled and consented for screening or surveillance colonoscopy
- Accept randomization to the study or the conventional method
- Agree to complete study questionnaires will be considered for enrollment
- Normal healthy patients or patients with mild systemic disease, ASA 1 or ASA 2
Exclusion Criteria:
- Patients who decline to participate, are unable to give informed consent or to
complete the questionnaires due to language or other difficulties will be excluded.
Excluded patients will be managed by usual procedures at the Sacramento VAMC
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| NCT ID: |
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NCT00920751 |
| Primary Contact: |
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Joseph W Leung, MD
Phone: 916-366-5339
Email: Joseph.Leung2@va.gov
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| Backup Contact: |
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N/A |
| Location Contact: |
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Mather, California 95655
United States
Joseph W Leung, MD
Phone: 916-366-5339
Email: Joseph.Leung2@va.gov
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 17, 2013 |
| Modifications to this listing: |
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