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Unsedated or slightly sedated colonoscopy has fast recovery time, less cost and lower or no incidence of drug-related side effects. May be slightly painful or discomforting for the patient. Based on numerous recent reports, the investigators designed this randomized controlled trial hypothesizing that the use of warm 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 or with a low dose of sedatives.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| warm water irrigation | Experimental | warm water irrigation during insertion phase of colonoscopy |
|
| air insufflation | Experimental | air insufflation during insertion phase of colonoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| air insufflation | Other | air insufflation during insertion phase colonoscopy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| number of patients undergoing complete unsedated or slightly sedated colonoscopy | number of patients undergoing complete unsedated conoloscopy with a pain score (as per used scale) ≤2, or patients with no more than that score AND ≤2 mg Midazolam E.V. | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| evaluation of pain and tolerability scores | Numeric rating scale, Verbal Descriptor Scale and Faces Pain Scale (0= no pain, 10 worst possible pain.) Hicks CL et al. Pain 2001;93:173-183. Bieri D. et al. Pain. 1990;41(2):138-50. | 1 hour |
| percentage of caecum intubation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sergio Cadoni, M.D. | A.S.L. 07 Sardegna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Servizio Endoscopia Digestiva | Iglesias | Carbonia-Iglesias | 09016 | Italy | ||
| U.O.S.D. Diagnostica e Terapia Endoscopica |
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| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| warm water irrigation |
| Other |
warm water irrigation during insertion phase colonoscopy |
|
| 1 hour |
| time to reach caecum | 1 hour |
| Adenoma detection rate | Proportion of patients with at least one adenoma of any size | 9 months |
| San Gavino Monreale |
| Medio Campidano (VS) |
| 09037 |
| Italy |