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Sedation Methods for Colorectal Cancer Screening
N/A
Waitlist Available
Research Sponsored by East Bay Institute for Research and Education
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Scheduled and consented for screening or surveillance colonoscopy
Normal healthy patients or patients with mild systemic disease, ASA 1 or ASA 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a method of doing colonoscopies without sedation in order to make the procedures more efficient. So far, the results show that the method is successful in 52% of cases and has benefits like shorter recovery time, better communication between patient and staff, and no need for next-day follow-up.
Who is the study for?
This trial is for adults over 50, both male and female, who are in good health or have mild systemic disease (ASA 1 or ASA 2). They must be scheduled for a colonoscopy for colorectal cancer screening or surveillance at the Sacramento VAMC, willing to be randomly assigned to a study method and agree to complete questionnaires. Those unable to consent or complete questionnaires due to language or other difficulties are excluded.
What is being tested?
The trial compares two methods of sedation during colonoscopy: the new 'study method' using water infusion instead of air insufflation versus the conventional method with air insufflation. It aims to see if the new method reduces medication needs, increases efficiency and patient willingness for future procedures, improves bowel preparation and polyp detection rate without compromising safety.
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects may include discomfort from less sedation with the study method compared to conventional methods. There could also be risks associated with water infusion such as bloating or cramping.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for a colonoscopy and have agreed to it.
Select...
I am generally healthy or have a mild health condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Water infusionExperimental Treatment1 Intervention
Water infusion in lieu of air insufflation during colonoscope insertion
Group II: Air insufflationActive Control1 Intervention
Conventional air insufflation colonoscopy
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Who is running the clinical trial?
East Bay Institute for Research and EducationLead Sponsor
8 Previous Clinical Trials
474 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for a colonoscopy and have agreed to it.I am generally healthy or have a mild health condition.I am over 50 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Water infusion
- Group 2: Air insufflation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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