Can Simple and Inexpensive Techniques Enhance Patient Comfort
Stopped early · Phase 1/Phase 2
Conditions studied: Colonoscopy
In brief
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 occur during the examination, waiting for the spasms to subside before continuing with the insertion of the colonoscope. The study method involves putting 200 ml (7 oz) of warm water through the colonoscope into the colon at the beginning of the examination, and when colonic spasms occur during the examination, putting 30 ml (1 oz) of warm water into the spastic area(s) to relax the colonic spasms.
Key facts
- Study ID
- NCT00747084
- Run by
- VA Office of Research and Development
- People needed
- 82
- Starts
- 2007-12-01
- Expected to finish
- 2012-12-01
- Last updated by the study team
- 2017-04-21
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- VA Greater Los Angeles Healthcare System, Sepulveda, CA — Sepulveda, California, United States
Full record on ClinicalTrials.gov
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