Impact of Carbon Dioxide Insufflation and Water Exchange on Post-Colonoscopy Outcomes
| Status: | Completed |
|---|---|
| Conditions: | Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 4/21/2016 |
| Start Date: | April 2015 |
| End Date: | November 2015 |
Impact of Carbon Dioxide Insufflation and Water Exchange on Post-Colonoscopy Outcomes: A Randomized Controlled Trial
Room air insufflated during colonoscopy cannot be completely suctioned, is not easily
absorbed and remains in the bowel for quite some time, resulting in prolonged bowel
distension with the discomfort of bloating. Sufferers often experience a sensation of
fullness and abdominal pressure, relieved only after expulsion of the residual gas, often
accompanied by colic pain. This can be a lengthy process, and some patients continue to
report pain as long as 24 hours after the procedure. Abdominal discomfort after colonoscopy
is an adverse event commonly reported by patients, and definitely associated with the
procedure. Published reports show that the use of carbon dioxide (CO2) insufflation
significantly decreases bloating and pain up to 24 hours post-procedure. Preliminary results
of the investigators' previous study about on-demand sedation colonoscopy in diagnostic
patients showed that, compared with CO2 insufflation, the water exchange group (WE, infusion
of water to distend the lumen during insertion; suction of infused water, residual air
pockets an feces predominantly during insertion) achieved significantly lower real-time
insertion pain scores. Moreover (insertion-withdrawal method) WE-CO2 had the lowest bloating
scores just after the procedure and at discharge, comparable with those achieved by CO2-CO2.
Compared with WE-CO2, the use of WE-air insufflation (AI) showed significantly higher
bloating scores just after the procedure and at discharge; compared with CO2-CO2 differences
were significant only at discharge. The investigators decided to conduct a prospective
randomized controlled trial comparing WE-CO2, WE-AI and CO2-CO2. The investigators will test
the hypothesis that patients examined by the combination of WE-CO2 will have significantly
lower bloating scores at specific time points after colonoscopy than those examined using
WE-AI or CO2-CO2. The investigators will also assess the impact of these three methods on
patients comfort and activities in the post-procedure period.
absorbed and remains in the bowel for quite some time, resulting in prolonged bowel
distension with the discomfort of bloating. Sufferers often experience a sensation of
fullness and abdominal pressure, relieved only after expulsion of the residual gas, often
accompanied by colic pain. This can be a lengthy process, and some patients continue to
report pain as long as 24 hours after the procedure. Abdominal discomfort after colonoscopy
is an adverse event commonly reported by patients, and definitely associated with the
procedure. Published reports show that the use of carbon dioxide (CO2) insufflation
significantly decreases bloating and pain up to 24 hours post-procedure. Preliminary results
of the investigators' previous study about on-demand sedation colonoscopy in diagnostic
patients showed that, compared with CO2 insufflation, the water exchange group (WE, infusion
of water to distend the lumen during insertion; suction of infused water, residual air
pockets an feces predominantly during insertion) achieved significantly lower real-time
insertion pain scores. Moreover (insertion-withdrawal method) WE-CO2 had the lowest bloating
scores just after the procedure and at discharge, comparable with those achieved by CO2-CO2.
Compared with WE-CO2, the use of WE-air insufflation (AI) showed significantly higher
bloating scores just after the procedure and at discharge; compared with CO2-CO2 differences
were significant only at discharge. The investigators decided to conduct a prospective
randomized controlled trial comparing WE-CO2, WE-AI and CO2-CO2. The investigators will test
the hypothesis that patients examined by the combination of WE-CO2 will have significantly
lower bloating scores at specific time points after colonoscopy than those examined using
WE-AI or CO2-CO2. The investigators will also assess the impact of these three methods on
patients comfort and activities in the post-procedure period.
Design: Prospective double blinded two-center randomized controlled trial. Methods:
Colonoscopy with CO2 insufflation and water exchange-CO2, water exchange-AI; split-dose
bowel preparation; on demand-sedation.
Control method: CO2 insufflation colonoscopy. Study methods: water exchange-CO2 colonoscopy,
water exchange-AI colonoscopy.
Population: Consecutive 18 to 80 year-old first-time diagnostic outpatients. After informed
consent, assignment to control or study arms based on computer generated randomization list
with block allocation and stratification.
Colonoscopy with CO2 insufflation and water exchange-CO2, water exchange-AI; split-dose
bowel preparation; on demand-sedation.
Control method: CO2 insufflation colonoscopy. Study methods: water exchange-CO2 colonoscopy,
water exchange-AI colonoscopy.
Population: Consecutive 18 to 80 year-old first-time diagnostic outpatients. After informed
consent, assignment to control or study arms based on computer generated randomization list
with block allocation and stratification.
Inclusion Criteria:
- consecutive 18 to 80 year-old first-time diagnostic outpatients agreeing to start
procedure without premedication
Exclusion Criteria:
- patient unwillingness to start the procedure without sedation/analgesia
- previous colorectal surgery
- proctosigmoidoscopy or bidirectional endoscopy
- patient refusal or inability to provide informed consent
- inadequate consumption of bowel preparation
- moderate or severe chronic obstructive pulmonary disease requiring oxygen
- medical history of CO2 retention
- history of inflammatory bowel disease
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Los Angeles, California 91343
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