Comparison of on Demand Sedation With Study Method Versus on Demand Sedation With Conventional Method for Performing Colonoscopy for Colorectal Cancer Screening and Surveillance
Recruitment status was Recruiting
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Purpose
Hypothesis
- Study method achieves lower requirement for medications
- Study method increases overall cecal intubation with comparable assessment of current experience and patient willingness to repeat future colonoscopy compared with conventional colonoscopy
- Study method results in reduction in medication-related (cardiorespiratory) complications, faster turn around of patients, compared with conventional colonoscopy
- 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 |
- Primary outcome - success of cecal intubation without sedation [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- 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 |
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| Contact: Joseph W Leung, MD | 916-366-5339 | Joseph.Leung2@va.gov |
| 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 | |
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 May 19, 2013