Techniques to Enhance Patient Comfort in Sedation-risk Free Colonoscopy
Recruitment status was Recruiting
- 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
- 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.
Screening of Colonic Polyps
Other: Warm water
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
|Official Title:||Can Simple and Inexpensive Techniques Enhance Patient Comfort in Sedation-risk Free Screening and Surveillance Colonoscopy?|
- abdominal discomfort [ Time Frame: 30 days ] [ Designated as safety issue: No ]Abdominal discomfort reported to a blinded observer 5-10 min after colonoscopy.
- colonoscopy-related outcomes [ Time Frame: 30 days ] [ Designated as safety issue: No ]various procedure related measures
|Study Start Date:||December 2007|
|Estimated Study Completion Date:||June 2011|
|Estimated Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Experimental: Warm water loading of sigmoid colon
Warm water loading of sigmoid colon and irrigation when spasms occur.
Other: Warm water
Warm water loading of sigmoid colon when spasms occur and waiting for them to subside.
Other Name: warm water
Placebo Comparator: Control
No water loading, only air and waiting for spasms to subside.
Air will be used instead of warm water for unsedated colonoscopy.
Other Name: air
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01076907
|Contact: Felix W. Leung, MDfirstname.lastname@example.org|
|Contact: Nora J. Jamgotchian, MSemail@example.com|
|United States, California|
|Greater Los Angeles Healthcare System and the Sepulveda Ambulatory Care Center||Recruiting|
|Los Angeles, California, United States, 91343|
|Contact: Nora J. Jamgotchian, MS 818-895-9426 firstname.lastname@example.org|
|Contact: Felix W. Leung, MD 818-895-9403 email@example.com|
|Principal Investigator: Felix W. Leung, MD|
|Principal Investigator:||Felix W. Leung, MD||VA Greater Los Angeles Healthcare System|