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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 1 year

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 below

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I am scheduled for a colonoscopy and have agreed to it.

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I am generally healthy or have a mild health condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

- 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.

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

East Bay Institute for Research and EducationLead Sponsor

8 Previous Clinical Trials

474 Total Patients Enrolled

Media Library

Air insufflation Clinical Trial Eligibility Overview. Trial Name: NCT00920751 — N/A

Colorectal Cancer Screening Research Study Groups: Water infusion, Air insufflation

Colorectal Cancer Screening Clinical Trial 2023: Air insufflation Highlights & Side Effects. Trial Name: NCT00920751 — N/A

Air insufflation 2023 Treatment Timeline for Medical Study. Trial Name: NCT00920751 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities to become involved in this scientific experiment?

"Evidently, this research project is not presently accepting applications. The trial was first listed on March 1st 2009 and the information concerning it has been revised for the last time June 12th 2009. Despite that, 860 other clinical trials are currently recruiting volunteers at present."

Answered by AI

Are there any age or health requirements for participation in this research endeavor?

"This medical trial is seeking to enroll 100 individuals from the age bracket of 50-80 who are clinically diagnosed with colorectal cancer. In addition, prospective participants must meet a range of criteria, including being in generally good health or having mild systemic diseases (ASA 1 and 2), consenting to screening or surveillance colonoscopy, agreeing to randomization between the study and conventional methods, as well as completing questionnaires for documentation purposes."

Answered by AI

Is the current research initiative open to individuals over 40?

"This clinical trial has established its age range of eligibilty at between 50 and 80 years old. There are 30 trials for younger participants, as well as 847 studies available to those over 65."

Answered by AI

Recent research and studies

Gastrointestinal EndoscopyJournal

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

Leung, Joseph, Surinder Mann, Rodelei Siao-Salera, Kanat Ransibrahmanakul, Brian Lim, Wilhelmina Canete, Laramie Samson, Rebeck Gutierrez, and Felix W. Leung. 2011. “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”. Gastrointestinal Endoscopy. Elsevier BV. doi:10.1016/j.gie.2010.09.020.

clinicaltrials.govStudy

Comparison of on Demand Sedation With Study Method Versus on Demand Sedation With Conventional Method for Performing Colonoscopy for Colorectal Cancer Screening and Surveillance

2009. "Comparison of on Demand Sedation With Study Method Versus on Demand Sedation With Conventional Method for Performing Colonoscopy for Colorectal Cancer Screening and Surveillance". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00920751.

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