N/A
N=420
Combination of Water Immersion and Carbon Dioxide Insufflation for Minimal Sedation Colonoscopy
Colonoscopy
Bottom Line
View on ClinicalTrials.gov: NCT01440543 ↗Enrolled (actual)
420
Serious AEs
—
Results posted
Jan 2013
Primary outcome: Primary: Success Rate of Minimal Sedation Colonoscopy
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Water immersion insertion AND CO2 insufflation (Procedure); Water immersion insertion (Procedure); CO2 insufflation (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vitkovice Hospital
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Success Rate of Minimal Sedation Colonoscopy |
82.4; 97; 97; 84.2 | — |
| PRIMARY Success Rate of Minimal Sedation Colonoscopy |
82.4; 97; 97; 84.2 | — |
| SECONDARY Patient Comfort During the Procedure and During First 24 Hours After Procedure |
— | — |
Summary
Water immersion insertion and carbon dioxide (CO2)instead of room air insufflation as alternative colonoscopy techniques have been documented to decrease patient discomfort during and after the procedure.
This prospective, randomized, single-center trial was designed to evaluate whether the combination of water immersion during insertion and CO2 insufflation during withdrawal (Water/CO2)for minimal sedation colonoscopy (2 mg of midazolam i.v.)is superior to the other colonoscopy methods (Water/Air, CO2/CO2, Air/Air).
Eligibility Criteria
Inclusion Criteria
- men and women older than 18 years referred for diagnostic outpatient colonoscopy
- provided written consent
Exclusion Criteria
- history of colorectal surgery
- known diagnosis of inflammatory bowel disease
- chronic benzodiazepine use
- refusal of minimal sedation
Data sourced from ClinicalTrials.gov (NCT01440543). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.