Can Simple and Inexpensive Techniques Enhance Patient Comfort
Information source: Department of Veterans Affairs
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Colonoscopy
Phase: N/A
Status: Recruiting
Sponsored by: Department of Veterans Affairs Official(s) and/or principal investigator(s):
Felix W. Leung, Principal Investigator, Affiliation: VA Greater Los Angeles Healthcare System, West LA
Overall contact:
Felix W Leung, Phone: (818) 891-7711, Email: Felix.Leung@va.gov
Summary
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.
Clinical Details
Official title: Can Simple and Inexpensive Techniques Enhance Patient Comfort in Sedation Risk-free Screening and Surveillance Colonoscopy?
Study design: Other, Other
Primary outcome: 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
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
Minimum age: 18 Years.
Maximum age: 95 Years.
Gender(s): Both.
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.
Locations and Contacts
Felix W Leung, Phone: (818) 891-7711, Email: Felix.Leung@va.gov
VA Greater Los Angeles Healthcare System, West LA, West Los Angeles, California 90073, United States; Recruiting
Nora J Jamgotchian, Phone: 818-895-9426, Email: nora.jamgotchian@va.gov
Felix W Leung, Phone: (818) 891-7711, Email: Felix.Leung@va.gov
Felix W. Leung, Principal Investigator
Additional Information
Starting date: December 2007
Ending date: September 2010
Last updated: July 27, 2009
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