Comparison of on Demand Sedation With Study Method Versus on Demand Sedation With Conventional Method for Performing Colonoscopy for Colorectal Cancer Screening and Surveillance
Primary Purpose
Colorectal Cancer Screening
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Water infusion
Air insufflation
Sponsored by
About this trial
This is an interventional screening trial for Colorectal Cancer Screening focused on measuring water infusion, air insufflation, colonoscopy, colorectal cancer screening
Eligibility Criteria
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
Sites / Locations
- Sacramento VA Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Water infusion
Air insufflation
Arm Description
Water infusion in lieu of air insufflation during colonoscope insertion
Conventional air insufflation colonoscopy
Outcomes
Primary Outcome Measures
Primary outcome - success of cecal intubation without sedation
Secondary Outcome Measures
Diagnostic yield, patients' current experience, willingness to repeat future colonoscopy, turn around time, and staff rating of satisfaction, and medication-related complications.
Full Information
NCT ID
NCT00920751
First Posted
June 11, 2009
Last Updated
June 12, 2009
Sponsor
East Bay Institute for Research and Education
1. Study Identification
Unique Protocol Identification Number
NCT00920751
Brief Title
Comparison of on Demand Sedation With Study Method Versus on Demand Sedation With Conventional Method for Performing Colonoscopy for Colorectal Cancer Screening and Surveillance
Official Title
Comparison of on Demand Sedation With Study Method Versus on Demand Sedation With Conventional Method for Performing Colonoscopy for Colorectal Cancer Screening and Surveillance
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Unknown status
Study Start Date
March 2009 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
East Bay Institute for Research and Education
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Hypothesis
Study method achieves lower requirement for medications
Study method increases overall cecal intubation with comparable assessment of current experience and patient willingness to repeat future colonoscopy compared with conventional colonoscopy
Study method results in reduction in medication-related (cardiorespiratory) complications, faster turn around of patients, compared with conventional colonoscopy
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer Screening
Keywords
water infusion, air insufflation, colonoscopy, colorectal cancer screening
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Water infusion
Arm Type
Experimental
Arm Description
Water infusion in lieu of air insufflation during colonoscope insertion
Arm Title
Air insufflation
Arm Type
Active Comparator
Arm Description
Conventional air insufflation colonoscopy
Intervention Type
Procedure
Intervention Name(s)
Water infusion
Intervention Description
Water infusion in lieu of air insufflation during colonoscope insertion
Intervention Type
Procedure
Intervention Name(s)
Air insufflation
Intervention Description
Conventional air insufflation colonoscopy
Primary Outcome Measure Information:
Title
Primary outcome - success of cecal intubation without sedation
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Diagnostic yield, patients' current experience, willingness to repeat future colonoscopy, turn around time, and staff rating of satisfaction, and medication-related complications.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joseph W Leung, MD
Phone
916-366-5339
Email
Joseph.Leung2@va.gov
Facility Information:
Facility Name
Sacramento VA Medical Center
City
Mather
State/Province
California
ZIP/Postal Code
95655
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph W Leung, MD
Phone
916-366-5339
Email
Joseph.Leung2@va.gov
12. IPD Sharing Statement
Citations:
PubMed Identifier
21184876
Citation
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.
Results Reference
derived
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Comparison of on Demand Sedation With Study Method Versus on Demand Sedation With Conventional Method for Performing Colonoscopy for Colorectal Cancer Screening and Surveillance
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