Can Simple and Inexpensive Techniques Enhance Patient Comfort
| Status: | Terminated |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 4/21/2016 |
| Start Date: | December 2007 |
| End Date: | December 2015 |
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.
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.
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.
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.
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