Techniques to Enhance Patient Comfort in Sedation-risk Free Colonoscopy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01076907|
Recruitment Status : Terminated (Necessary equipment to perform the study arms was removed by the medical center administration.)
First Posted : February 26, 2010
Last Update Posted : December 15, 2015
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Screening of Colonic Polyps||Other: Warm water Other: Control||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||85 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Can Simple and Inexpensive Techniques Enhance Patient Comfort in Sedation-risk Free Screening and Surveillance Colonoscopy?|
|Study Start Date :||December 2007|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||June 2011|
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.
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
- abdominal discomfort [ Time Frame: 30 days ]Abdominal discomfort reported to a blinded observer 5-10 min after colonoscopy.
- colonoscopy-related outcomes [ Time Frame: 30 days ]various procedure related measures
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01076907
|United States, California|
|Greater Los Angeles Healthcare System and the Sepulveda Ambulatory Care Center|
|Los Angeles, California, United States, 91343|
|Principal Investigator:||Felix W. Leung, MD||VA Greater Los Angeles Healthcare System|