Techniques to Enhance Patient Comfort in Sedation-risk Free Colonoscopy
| Status: | Terminated |
|---|---|
| Conditions: | Colorectal Cancer, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Oncology |
| Healthy: | No |
| Age Range: | 18 - 95 |
| Updated: | 4/21/2016 |
| Start Date: | December 2007 |
| End Date: | June 2011 |
Can Simple and Inexpensive Techniques Enhance Patient Comfort in Sedation-risk Free Screening and Surveillance Colonoscopy?
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.
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.
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.
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.
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
We found this trial at
1
site
Los Angeles, California 91343
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