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

Colorectal Cancer Screening Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00920751
• Other study ID #: EBIRE-GI-003
• Status: Recruiting
• Phase: N/A
• First received: June 11, 2009
• Last updated: June 12, 2009
• Start date: March 2009

Study information

• Verified date: June 2009
• Source: East Bay Institute for Research and Education
• Contact: Joseph W Leung, MD
• Phone: 916-366-5339
• Email: Joseph.Leung2[@]va.gov
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Screening

Related Conditions & MeSH terms

• Colorectal Cancer Screening
• Colorectal Neoplasms

Intervention

Procedure:
• Water infusion
Water infusion in lieu of air insufflation during colonoscope insertion
• Air insufflation
Conventional air insufflation colonoscopy

Locations

Country	Name	City	State
United States	Sacramento VA Medical Center	Mather	California

Sponsors (1)

Lead Sponsor	Collaborator
East Bay Institute for Research and Education

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary outcome - success of cecal intubation without sedation		1 year	No
Secondary	Diagnostic yield, patients' current experience, willingness to repeat future colonoscopy, turn around time, and staff rating of satisfaction, and medication-related complications.		1 year	No