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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by East Bay Institute for Research and Education.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
East Bay Institute for Research and Education
ClinicalTrials.gov Identifier:
NCT00920751
First received: June 11, 2009
Last updated: June 12, 2009
Last verified: June 2009

June 11, 2009
June 12, 2009
March 2009
Not Provided
Primary outcome - success of cecal intubation without sedation [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00920751 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparison of on Demand Sedation With Study Method Versus on Demand Sedation With Conventional Method for Performing Colonoscopy for Colorectal Cancer Screening and Surveillance
Comparison of on Demand Sedation With Study Method Versus on Demand Sedation With Conventional Method for Performing Colonoscopy for Colorectal Cancer Screening and Surveillance

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Screening
Colorectal Cancer Screening
  • Procedure: Water infusion
    Water infusion in lieu of air insufflation during colonoscope insertion
  • Procedure: Air insufflation
    Conventional air insufflation colonoscopy
  • Experimental: Water infusion
    Water infusion in lieu of air insufflation during colonoscope insertion
    Intervention: Procedure: Water infusion
  • Active Comparator: Air insufflation
    Conventional air insufflation colonoscopy
    Intervention: Procedure: Air insufflation
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
Not Provided
Not Provided

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
Both
50 Years to 80 Years
Yes
Contact: Joseph W Leung, MD 916-366-5339 Joseph.Leung2@va.gov
United States
 
NCT00920751
EBIRE-GI-003
Yes
Joseph Leung, MD, Sacramento VA Medical Center
East Bay Institute for Research and Education
Not Provided
Not Provided
East Bay Institute for Research and Education
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP