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

Sponsor:	Department of Veterans Affairs
Information provided by:	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
Colonoscopy

Study Type:	Observational
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 Drinking Water

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	95
Study Start Date:	December 2007
Estimated Study Completion Date:	September 2010
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Study Treatment: warm water loading of the sigmoid colon and warm water irrigation for dealing with colonic spasms.
2 Control Treatment: no water loading and waiting for spasms to subside.

Detailed Description:

The purpose of the study is 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
Sampling Method:	Probability Sample

Study Population

Any patients from the GLAVA, over 18 years of age are considered to be the study population.

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 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

Responsible Party:	Department of Veterans Affairs ( Leung, Felix - Principal Investigator )
Study ID Numbers:	FLVA0055
Study First Received:	September 3, 2008
Last Updated:	December 18, 2009
ClinicalTrials.gov Identifier:	NCT00747084 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

unsedated colonoscopy

ClinicalTrials.gov processed this record on February 09, 2010