Screening of Colonic Polyps Clinical Trial
Official title:
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.
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. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic