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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer Screening
• Intervention / Treatment: Procedure: Water infusion; Procedure: Air insufflation

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joseph W Leung, MD; Phone Number: 916-366-5339; Email: Joseph.Leung2@va.gov

Study Locations

• United States
  • California
    • Mather, California, United States, 95655
      • Recruiting
      • Sacramento VA Medical Center
      • Contact: Joseph W Leung, MD; Phone Number: 916-366-5339; Email: Joseph.Leung2@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Primary outcome - success of cecal intubation without sedation	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Diagnostic yield, patients' current experience, willingness to repeat future colonoscopy, turn around time, and staff rating of satisfaction, and medication-related complications.	1 year

Collaborators and Investigators

• Sponsor: East Bay Institute for Research and Education

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2009

Study Registration Dates

• First Submitted: June 11, 2009
• First Submitted That Met QC Criteria: June 12, 2009
• First Posted (Estimate): June 15, 2009

Study Record Updates

• Last Update Posted (Estimate): June 15, 2009
• Last Update Submitted That Met QC Criteria: June 12, 2009
• Last Verified: June 1, 2009

More Information

Terms related to this study

• Keywords: colonoscopy; colorectal cancer screening; water infusion; air insufflation
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: EBIRE-GI-003