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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

September 3, 2008
October 25, 2012
December 2007
December 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00747084 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Can Simple and Inexpensive Techniques Enhance Patient Comfort
Can Simple and Inexpensive Techniques Enhance Patient Comfort in Sedation Risk-free Screening and Surveillance Colonoscopy?

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.

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: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Colonoscopy
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.
  • Experimental: Arm 1
    Study Treatment: warm water loading of the sigmoid colon and warm water irrigation for dealing with colonic spasms.
    Intervention: Other: Colonoscopy
  • No Intervention: Arm 2
    Control Treatment: no water loading and waiting for spasms to subside.
Leung FW, Harker JO, Jackson G, Okamoto KE, Behbahani OM, Jamgotchian NJ, Aharonian HS, Guth PH, Mann SK, Leung JW. A proof-of-principle, prospective, randomized, controlled trial demonstrating improved outcomes in scheduled unsedated colonoscopy by the water method. Gastrointest Endosc. 2010 Oct;72(4):693-700. Epub 2010 Jul 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
100
March 2013
December 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00747084
FLVA0055
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Felix W. Leung VA Greater Los Angeles Healthcare System, West LA
Department of Veterans Affairs
October 2012

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