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Techniques to Enhance Patient Comfort in Sedation-risk Free Colonoscopy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by VA Greater Los Angeles Healthcare System.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
VA Greater Los Angeles Healthcare System
ClinicalTrials.gov Identifier:
NCT01076907
First received: February 25, 2010
Last updated: February 26, 2010
Last verified: February 2010

February 25, 2010
February 26, 2010
December 2007
December 2010   (final data collection date for primary outcome measure)
abdominal discomfort [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Abdominal discomfort reported to a blinded observer 5-10 min after colonoscopy.
abdominal discomfort [ Time Frame: Immediately after the procedure ] [ Designated as safety issue: No ]
Abdominal discomfort reported to a blinded observer 5-10 min after colonoscopy.
Complete list of historical versions of study NCT01076907 on ClinicalTrials.gov Archive Site
colonoscopy-related outcomes [ Time Frame: 30 days ] [ Designated as safety issue: No ]
various procedure related measures
colonoscopy-related outcomes [ Time Frame: during colonoscopy ] [ Designated as safety issue: No ]
various procedure related measures
Not Provided
Not Provided
 
Techniques to Enhance Patient Comfort in Sedation-risk Free Colonoscopy
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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Screening of Colonic Polyps
  • Other: Warm water
    Warm water loading of sigmoid colon when spasms occur and waiting for them to subside.
    Other Name: warm water
  • Other: Control
    Air will be used instead of warm water for unsedated colonoscopy.
    Other Name: air
  • Experimental: Warm water loading of sigmoid colon
    Warm water loading of sigmoid colon and irrigation when spasms occur.
    Intervention: Other: Warm water
  • Placebo Comparator: Control
    No water loading, only air and waiting for spasms to subside.
    Intervention: Other: Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
June 2011
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 95 Years
Yes
Contact: Felix W. Leung, MD 818-895-9403 felix.leung@va.gov
Contact: Nora J. Jamgotchian, MS 818-895-9426 nora.jamgotchian@va.gov
United States
 
NCT01076907
FL0055
No
Felix W. Leung, M.D./Principal Investigator, Sepulveda Ambulatory Care Center, VAGLAHS
VA Greater Los Angeles Healthcare System
Not Provided
Principal Investigator: Felix W. Leung, MD VA Greater Los Angeles Healthcare System
VA Greater Los Angeles Healthcare System
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP