Status:
TERMINATED
Can Simple and Inexpensive Techniques Enhance Patient Comfort
Lead Sponsor:
VA Office of Research and Development
Conditions:
Colonoscopy
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
This research study compares two methods of performing colonoscopy without sedation. The standard method is to insert the colonoscope without adding any water to the colon, and when colonic spasms occ...
Detailed Description
The purpose of the study is to conduct a RCT study to determine the effectiveness of loading the sigmoid colon with warm water and warm water irrigation for dealing with colonic spasms in enhancing pa...
Eligibility Criteria
Inclusion
- Adult male and female
- Adult patients 18 years old in need of colonoscopy for screening or follow up of colonic polyps, and willing to consent to be randomized.
Exclusion
- Patients receiving outpatient prescription narcotic treatment \[more likely to have discomfort response even with sedation (42)\].
- Patients who report excessive anxiety \[pre-endoscopy appointment, single question asking how anxious the patient generally is, four point scale (1 = not at all, 2 = slightly, 3 = moderately, 4 = excessively\].
- Excessive anxiety is significantly correlated with lack of cooperation during colonoscopy and high dissatisfaction score after the procedure (43).
- Patients with moderate to severe abdominal discomfort, unable to provide informed consent, have a poor bowel preparation (discolored rectal output or feces filled rectal vault), and those who decline to participate, will also be excluded.
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT00747084
Start Date
December 1 2007
End Date
December 1 2012
Last Update
April 21 2017
Active Locations (1)
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1
VA Greater Los Angeles Healthcare System, Sepulveda, CA
Sepulveda, California, United States, 91343