Techniques to Enhance Patient Comfort in Sedation-risk Free Colonoscopy

Stopped early · Phase 1/Phase 2

Conditions studied: Screening of Colonic Polyps

In brief

Hypotheses 1. Loading the sigmoid colon with warm water and warm water irrigation for dealing with spasm (Study Treatment) will significantly reduce the proportion of patients complaining of abdominal discomfort compared with no water loading and waiting for spasms to subside (Control Treatment). The median discomfort score reported by the patients will be significantly lower in the group receiving the Study Treatment than the group receiving Control Treatment. Hypothesis 2. Exploratory hypothesis: There are differences in secondary outcome variables when patients managed by the Study and Control Treatments are compared. Co-variables affect the primary and secondary outcome variables.

Key facts

Study ID

NCT01076907

Run by

VA Greater Los Angeles Healthcare System

People needed

85

Starts

2007-12-01

Expected to finish

2011-06-01

Last updated by the study team

2015-12-15

Who can join

Age: 18 and older, up to 95. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Accepts adult healthy male and female patients
• At least 18 years of age
• In need of colonoscopy for screening or follow up of colonic polyps
• Willing to consent and be randomized

You may not qualify if…

• Patients receiving outpatient narcotic treatment
• Patients who report excessive anxiety
• Patients with moderate to severe abdominal discomfort
• Unable to provide consent
• Have poor bowel preparation

Where it is running

• Greater Los Angeles Healthcare System and the Sepulveda Ambulatory Care Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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