Screening of Colonic Polyps
Conditions
Keywords
colonoscopy, polyps
Brief summary
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.
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 patient abdominal comfort during unsedated colonoscopy. The specific aim is to compare Study Treatment of warm water loading and irrigation when spasms occur with Control Treatment of no water loading and waiting for spasms to subside. The proportion of patients complaining of abdominal discomfort and their discomfort score are the primary outcome variables. The secondary outcome variables and co-variables described below will be recorded in a prospective manner to ensure completeness of data collection. In preliminary clinical observation at VA Sepulveda ACC, 25 to 30% of VA patients accept colonoscopy without sedation. The goal of this study is to find ways of further reducing discomfort associated with unsedated colonoscopy.
Interventions
OTHERWarm water
Warm water loading of sigmoid colon when spasms occur and waiting for them to subside.
OTHERControl
Air will be used instead of warm water for unsedated colonoscopy.
Sponsors
VA Greater Los Angeles Healthcare System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| abdominal discomfort | 30 days | Abdominal discomfort reported to a blinded observer 5-10 min after colonoscopy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| colonoscopy-related outcomes | 30 days | various procedure related measures |
Countries
United States
Outcome results
None listed