Unsedated Colonoscopy for Colorectal Cancer Screening and Surveillance

Colon Polyp Clinical Trial

Official title:

Comparison of Study Method Versus Conventional Method for Performing Unsedated Colonoscopy for Colorectal Cancer Screening and Surveillance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01383252
• Other study ID #: VANCHCS-GI-005
• Status: Completed
• Phase: N/A
• First received: June 21, 2011
• Last updated: June 13, 2013
• Start date: February 2010
• Est. completion date: June 2013

Study information

• Verified date: June 2013
• Source: VA Northern California Health Care System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

In a prospective, randomized, controlled study, two methods (water method vs. air method) of performing colonoscopy will be compared in patients undergoing unsedated colonoscopy for CRC screening. The investigators hypothesize that:

1. Study method increases overall cecal intubation with comparable assessment of current experience and patient willingness to repeat future colonoscopy compared with conventional colonoscopy

2. Study method improves bowel preparation and increases polyp pickup rate

Description:

Colorectal cancer (CRC) screening for the high and the low risk healthy asymptomatic Veterans Affairs (VA) patients is being promoted. 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.

In a prospective, randomized, controlled trial (RCT), two methods of performing colonoscopy will be compared in patients undergoing unsedated colonoscopy for CRC screening. We compared the water infusion in lieu of air insufflation (water method) with the conventional air insufflation method. We hypothesize that the water method (Study method) increases overall cecal intubation with comparable assessment of current experience and patient willingness to repeat future colonoscopy compared with conventional colonoscopy. In addition, the water method improves bowel preparation and increases polyp pickup rate.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

• Adult (>50 years old)

• Male and female patients

• Scheduled and consented for screening or surveillance colonoscopy without medications

• Accept randomization to the study or the conventional method

• Agree to complete study questionnaires

• The adults will be normal healthy patients or patients with mild systemic disease, ASA 1 or ASA 2.

Exclusion Criteria:

• Patients who decline to participate

• Unable to give informed consent or complete the questionnaires due to language or other difficulties

Study Design

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

Related Conditions & MeSH terms

• Colon Polyp
• Colorectal Neoplasms

Intervention

Procedure:
• Water infusion in lieu of air insufflation
Air pump is turned off, water is infused using a peristaltic pump to aid colonoscope insertion until the cecum is reached. Air pockets and dirty water are suctioned before clean water is infused (exchange) to facilitate scope insertion.
• Air method
Conventional air method with minimal insufflation of air to aid scope insertion until the cecum is reached. Water in aliquots will be used for irrigation and cleansing.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
VA Northern California Health Care System

Country where clinical trial is conducted

United States, 

References & Publications (4)

Leung FW, Mann SK, Salera R, Toomsen L, Cabrera H, Prather D, Gutierrez R, Leung JW. Options for screening colonoscopy without sedation: sequel to a pilot study in U.S. veterans. Gastrointest Endosc. 2008 Apr;67(4):712-7. doi: 10.1016/j.gie.2007.10.028. Epub 2008 Feb 14. — View Citation

Leung JW, Mann S, Leung FW. Options for screening colonoscopy without sedation: a pilot study in United States veterans. Aliment Pharmacol Ther. 2007 Aug 15;26(4):627-31. Review. — View Citation

Leung JW, Mann SK, Siao-Salera R, Ransibrahmanakul K, Lim B, Cabrera H, Canete W, Barredo P, Gutierrez R, Leung FW. A randomized, controlled comparison of warm water infusion in lieu of air insufflation versus air insufflation for aiding colonoscopy insertion in sedated patients undergoing colorectal cancer screening and surveillance. Gastrointest Endosc. 2009 Sep;70(3):505-10. doi: 10.1016/j.gie.2008.12.253. Epub 2009 Jun 24. — View Citation

Leung JW, Salera R, Toomsen L, Mann S, Leung FW. Pilot feasibility study of the method of water infusion without air insufflation in sedated colonoscopy. Dig Dis Sci. 2009 Sep;54(9):1997-2001. doi: 10.1007/s10620-008-0576-4. Epub 2008 Dec 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success of colonoscopy	successful cecal intubation	24 months	No
Secondary	Polyp detection	Adenoma detection rate	24 months	No