N/A
N=230
Warm Water for Unsedated Colonoscopy
Colonoscopy
Bottom Line
View on ClinicalTrials.gov: NCT00905554 ↗Enrolled (actual)
230
Serious AEs
0.0%
Results posted
Oct 2011
Primary outcome: Primary: Number of Patients Undergoing Complete Unsedated Colonoscopy — 101; 89 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- warm water irrigation (Procedure); air insufflation (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Valduce Hospital
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Undergoing Complete Unsedated Colonoscopy |
101; 89 | — |
| SECONDARY Evaluation of Pain and Tolerability Scores |
28; 39 | — |
Summary
Unsedated colonoscopy is characterized by lower costs, recovery time and incidence of drug-related side effects, although it may be painful for the patient. Based on recent reports, the investigators designed this randomized controlled trial hypothesizing that the use of water irrigation versus air insufflation during the insertion phase of colonoscopy might increase the global tolerability of the examination and the proportion of patients undergoing complete colonoscopy without sedation.
Eligibility Criteria
Inclusion Criteria
- adult outpatients willing to undergo colonoscopy without routine initial sedation
Exclusion Criteria
- refuse to initiate colonoscopy without routine sedation
- inadequate bowel preparation
- incapacity to give informed consent
Data sourced from ClinicalTrials.gov (NCT00905554). 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.