Trial Information
Comparison of on Demand Sedation With Study Method Versus on Demand Sedation With Conventional Method for Performing Colonoscopy for Colorectal Cancer Screening and Surveillance
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Screening
Outcome Measure:
Primary outcome - success of cecal intubation without sedation
Outcome Time Frame:
1 year
Safety Issue:
No
Authority:
United States: Institutional Review Board
Study ID:
EBIRE-GI-003
NCT ID:
NCT00920751
Start Date:
March 2009
Completion Date:
Related Keywords:
- Colorectal Cancer Screening
- water infusion
- air insufflation
- colonoscopy
- colorectal cancer screening
- Colorectal Neoplasms
Name | Location |
Sacramento VA Medical Center |
Mather, California 95655 |