Study Stopped
Necessary equipment to perform the study arms was removed by the medical center administration.
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?
1 other identifier
interventional
85
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Dec 2007
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 25, 2010
CompletedFirst Posted
Study publicly available on registry
February 26, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedDecember 15, 2015
December 1, 2015
3.5 years
February 25, 2010
December 14, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
abdominal discomfort
Abdominal discomfort reported to a blinded observer 5-10 min after colonoscopy.
30 days
Secondary Outcomes (1)
colonoscopy-related outcomes
30 days
Study Arms (2)
Warm water loading of sigmoid colon
EXPERIMENTALWarm water loading of sigmoid colon and irrigation when spasms occur.
Control
PLACEBO COMPARATORNo water loading, only air and waiting for spasms to subside.
Interventions
Warm water loading of sigmoid colon when spasms occur and waiting for them to subside.
Air will be used instead of warm water for unsedated colonoscopy.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Greater Los Angeles Healthcare System and the Sepulveda Ambulatory Care Center
Los Angeles, California, 91343, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Felix W. Leung, MD
VA Greater Los Angeles Healthcare System
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Staff Physician
Study Record Dates
First Submitted
February 25, 2010
First Posted
February 26, 2010
Study Start
December 1, 2007
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
December 15, 2015
Record last verified: 2015-12