Can Simple and Inexpensive Techniques Enhance Patient Comfort - Full Text View

Sponsor:	Department of Veterans Affairs
Information provided by (Responsible Party):	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00747084

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 I Phase II

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:

MedlinePlus related topics: Colonoscopy

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:	September 2012
Estimated Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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: 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

Contacts

Contact: Felix W Leung	(818) 891-7711	Felix.Leung@va.gov
Contact: Nora J Jamgotchian	(818) 895-9426	nora.jamgotchian@va.gov

Locations

United States, California
VA Greater Los Angeles HCS, Sepulveda	Recruiting
Sepulveda, California, United States, 91343
Contact: Nora J Jamgotchian 818-895-9426 nora.jamgotchian@va.gov
Contact: Felix W Leung (818) 891-7711 Felix.Leung@va.gov
Sub-Investigator: Nora J. Jamgotchian
VA Greater Los Angeles HCS, Sepulveda	Recruiting
Sepulveda, California, United States, 91343
Contact: Nora J Jamgotchian, MS 818-895-9426 nora.jamgotchian@va.gov
VA Greater Los Angeles Healthcare System, West LA	Recruiting
West Los Angeles, California, United States, 90073
Contact: Nora J Jamgotchian 818-895-9426 nora.jamgotchian@va.gov
Contact: Felix W Leung (818) 891-7711 Felix.Leung@va.gov
Principal Investigator: Felix W. Leung

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):

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.

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:	September 7, 2011
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

unsedated colonoscopy

ClinicalTrials.gov processed this record on February 09, 2012