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Can Simple and Inexpensive Techniques Enhance Patient Comfort

This study has suspended participant recruitment.
(Instruments necessary to contiue project have been removed via medical center staff. Therefore, the project cannot continue until they have been replaced.)
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00747084
First received: September 3, 2008
Last updated: October 25, 2012
Last verified: October 2012
History of Changes
  Purpose

This research study compares two methods of performing colonoscopy without sedation. The standard method is to insert the colonoscope without adding any water to the colon, and when colonic spasms occur during the examination, waiting for the spasms to subside before continuing with the insertion of the colonoscope. The study method involves putting 200 ml (7 oz) of warm water through the colonoscope into the colon at the beginning of the examination, and when colonic spasms occur during the examination, putting 30 ml (1 oz) of warm water into the spastic area(s) to relax the colonic spasms.


Condition Intervention Phase
Colonoscopy
 Other: Colonoscopy
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group 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:

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 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 [ Time Frame: Immediately after the procedure. ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: December 2007
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Study Treatment: warm water loading of the sigmoid colon and warm water irrigation for dealing with colonic spasms.
 Other: Colonoscopy
The purpose of the study is to conduct an 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.
No Intervention: Arm 2
Control Treatment: no water loading and waiting for spasms to subside.

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 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult male and female
  • Adult patients 18 years old in need of colonoscopy for screening or follow up of colonic polyps, and willing to consent to be randomized.

Exclusion Criteria:

  • Patients receiving outpatient prescription narcotic treatment [more likely to have discomfort response even with sedation (42)].
  • Patients who report excessive anxiety [pre-endoscopy appointment, single question asking how anxious the patient generally is, four point scale (1 = not at all, 2 = slightly, 3 = moderately, 4 = excessively].
  • Excessive anxiety is significantly correlated with lack of cooperation during colonoscopy and high dissatisfaction score after the procedure (43).
  • Patients with moderate to severe abdominal discomfort, unable to provide informed consent, have a poor bowel preparation (discolored rectal output or feces filled rectal vault), and those who decline to participate, will also be excluded.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00747084

Locations
United States, California
VA Greater Los Angeles HCS, Sepulveda
Sepulveda, California, United States, 91343
Sponsors and Collaborators
Department of Veterans Affairs
Investigators
Principal Investigator: Felix W. Leung VA Greater Los Angeles Healthcare System, West LA
  More Information

No publications provided by Department of Veterans Affairs

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00747084     History of Changes
Other Study ID Numbers: FLVA0055
Study First Received: September 3, 2008
Last Updated: October 25, 2012
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
unsedated colonoscopy

ClinicalTrials.gov processed this record on June 17, 2013