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
  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
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?

Resource links provided by NLM:


Further study details as provided by VA Greater Los Angeles Healthcare System:

Primary Outcome Measures:
  • abdominal discomfort [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Abdominal discomfort reported to a blinded observer 5-10 min after colonoscopy.


Secondary Outcome Measures:
  • colonoscopy-related outcomes [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    various procedure related measures


Estimated Enrollment: 120
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)
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.
Other Name: warm water
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

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01076907

Contacts
Contact: Felix W. Leung, MD 818-895-9403 felix.leung@va.gov
Contact: Nora J. Jamgotchian, MS 818-895-9426 nora.jamgotchian@va.gov

Locations
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    nora.jamgotchian@va.gov   
Contact: Felix W. Leung, MD    818-895-9403    felix.leung@va.gov   
Principal Investigator: Felix W. Leung, MD         
Sponsors and Collaborators
VA Greater Los Angeles Healthcare System
Investigators
Principal Investigator: Felix W. Leung, MD VA Greater Los Angeles Healthcare System
  More Information

No publications provided

Responsible Party: Felix W. Leung, M.D./Principal Investigator, Sepulveda Ambulatory Care Center, VAGLAHS
ClinicalTrials.gov Identifier: NCT01076907     History of Changes
Other Study ID Numbers: FL0055
Study First Received: February 25, 2010
Last Updated: February 26, 2010
Health Authority: United States: Federal Government

Keywords provided by VA Greater Los Angeles Healthcare System:
colonoscopy
polyps

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

ClinicalTrials.gov processed this record on October 20, 2014