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Techniques to Enhance Patient Comfort in Sedation-risk Free Colonoscopy

This study has been terminated.
(Necessary equipment to perform the study arms was removed by the medical center administration.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01076907
First Posted: February 26, 2010
Last Update Posted: December 15, 2015
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.
Information provided by (Responsible Party):
Felix W. Leung, VA Greater Los Angeles Healthcare System
  Purpose

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.

Condition Intervention Phase
Screening of Colonic Polyps Other: Warm water Other: Control Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Can Simple and Inexpensive Techniques Enhance Patient Comfort in Sedation-risk Free Screening and Surveillance Colonoscopy?

Resource links provided by NLM:


Further study details as provided by Felix W. Leung, VA Greater Los Angeles Healthcare System:

Primary Outcome Measures:
  • abdominal discomfort [ Time Frame: 30 days ]
    Abdominal discomfort reported to a blinded observer 5-10 min after colonoscopy.


Secondary Outcome Measures:
  • colonoscopy-related outcomes [ Time Frame: 30 days ]
    various procedure related measures


Enrollment: 85
Study Start Date: December 2007
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: Control
Air will be used instead of warm water for unsedated colonoscopy.
Other Name: air

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, California
Greater Los Angeles Healthcare System and the Sepulveda Ambulatory Care Center
Los Angeles, California, United States, 91343
Sponsors and Collaborators
VA Greater Los Angeles Healthcare System
Investigators
Principal Investigator: Felix W. Leung, MD VA Greater Los Angeles Healthcare System
  More Information

Responsible Party: Felix W. Leung, Staff Physician, VA Greater Los Angeles Healthcare System
ClinicalTrials.gov Identifier: NCT01076907     History of Changes
Other Study ID Numbers: FL0055
First Submitted: February 25, 2010
First Posted: February 26, 2010
Last Update Posted: December 15, 2015
Last Verified: December 2015

Keywords provided by Felix W. Leung, VA Greater Los Angeles Healthcare System:
colonoscopy
polyps

Additional relevant MeSH terms:
Colonic Polyps
Intestinal Polyps
Polyps
Pathological Conditions, Anatomical


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