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
  Purpose

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.


Condition Intervention
Colorectal Cancer Screening
Procedure: Water infusion
Procedure: Air insufflation

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

Resource links provided by NLM:


Further study details as provided by East Bay Institute for Research and Education:

Primary Outcome Measures:
  • Primary outcome - success of cecal intubation without sedation [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: March 2009
Arms Assigned Interventions
Experimental: Water infusion
Water infusion in lieu of air insufflation during colonoscope insertion
Procedure: Water infusion
Water infusion in lieu of air insufflation during colonoscope insertion
Active Comparator: Air insufflation
Conventional air insufflation colonoscopy
Procedure: Air insufflation
Conventional air insufflation colonoscopy

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00920751

Contacts
Contact: Joseph W Leung, MD 916-366-5339 Joseph.Leung2@va.gov

Locations
United States, California
Sacramento VA Medical Center Recruiting
Mather, California, United States, 95655
Contact: Joseph W Leung, MD    916-366-5339    Joseph.Leung2@va.gov   
Sponsors and Collaborators
East Bay Institute for Research and Education
  More Information

No publications provided by East Bay Institute for Research and Education

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Joseph Leung, MD, Sacramento VA Medical Center
ClinicalTrials.gov Identifier: NCT00920751     History of Changes
Other Study ID Numbers: EBIRE-GI-003
Study First Received: June 11, 2009
Last Updated: June 12, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by East Bay Institute for Research and Education:
water infusion
air insufflation
colonoscopy
colorectal cancer screening

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on October 19, 2014