Comparison of on Demand Sedation With Study Method Versus on Demand Sedation With Conventional Method for Performing Colonoscopy for Colorectal Cancer Screening and Surveillance
1 other identifier
interventional
100
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 11, 2009
CompletedFirst Posted
Study publicly available on registry
June 15, 2009
CompletedJune 15, 2009
June 1, 2009
June 11, 2009
June 12, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary outcome - success of cecal intubation without sedation
1 year
Secondary Outcomes (1)
Diagnostic yield, patients' current experience, willingness to repeat future colonoscopy, turn around time, and staff rating of satisfaction, and medication-related complications.
1 year
Study Arms (2)
Water infusion
EXPERIMENTALWater infusion in lieu of air insufflation during colonoscope insertion
Air insufflation
ACTIVE COMPARATORConventional air insufflation colonoscopy
Interventions
Water infusion in lieu of air insufflation during colonoscope insertion
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sacramento VA Medical Center
Mather, California, 95655, United States
Related Publications (1)
Leung J, Mann S, Siao-Salera R, Ransibrahmanakul K, Lim B, Canete W, Samson L, Gutierrez R, Leung FW. A randomized, controlled trial to confirm the beneficial effects of the water method on U.S. veterans undergoing colonoscopy with the option of on-demand sedation. Gastrointest Endosc. 2011 Jan;73(1):103-10. doi: 10.1016/j.gie.2010.09.020.
PMID: 21184876DERIVED
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 11, 2009
First Posted
June 15, 2009
Study Start
March 1, 2009
Last Updated
June 15, 2009
Record last verified: 2009-06