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The study was aimed to prospectively evaluate the acceptance rate of unsedated colonoscopy, in a setting where routine sedation for colonoscopy is standard practice and to characterize the subset of patients willing to try and potentially completing an unsedated procedure.
Patients were offered to undergo colonoscopy without routine premedication. In case of both acceptance and refusal, a brief questionnaire recording demographics (gender, age, level of education) and clinical features was prospectively recorded in a standard data sheet by one of the four endoscopists at enrollment. Clinical features recorded for each patient included: indication to the procedure, history of abdominal surgery or irritable bowel syndrome, presence of pain as main symptom, chronic use of sedative medications, level of patient's anxiety (none, mild, moderate or severe), main concern about the examination and reason for willing to attempt unsedated procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colonoscopy outpatients | All patients referred to our Unit to undergo colonoscopy for any indication |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Unsedated colonoscopy | Procedure | Patients were offered to undergo colonoscopy without routine premedication |
|
| Measure | Description | Time Frame |
|---|---|---|
| ODDS ratio for unsedated colonoscopy acceptance | Multivariate analysis was used to assess the association of dempgraphics (gender, age, level of education) and clinical features (indication to the procedure, history of abdominal surgery or irritable bowel syndrome, presence of pain as main symptom, chronic use of sedative medications, level of patient's anxiety (none, mild, moderate or severe), main concern about the examination and reason for willing to attempt unsedated procedure) to the acceptance of unsedated colonoscopy | up to 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptance rate of unsedated colonoscopy | Proportion of patients accepting to attempt colonoscopy without routine premedication | up to 8 months |
| ODDS ratios for unsedated colonoscopy completion |
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Inclusion Criteria:
Exclusion Criteria:
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all consecutive 18-80 year-old outpatients presenting to undergo open-access colonoscopy for routine indications were considered eligible to enter the study.
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| Name | Affiliation | Role |
|---|---|---|
| Franco Radaelli, MD | Valduce Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vadluce Hospital | Como | 22100 | Italy |
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| Unsedated colonoscopy | Procedure | Patients were offered to undergo unsedated procedure. Their demographics and clinical data were recorded |
|
Multivariate analysis was used to assess the association of dempgraphics (gender, age, level of education) and clinical features (indication to the procedure, history of abdominal surgery or irritable bowel syndrome, presence of pain as main symptom, chronic use of sedative medications, level of patient's anxiety (none, mild, moderate or severe), main concern about the examination and reason for willing to attempt unsedated procedure) to the completion of unsedated colonoscopy
| up to 8 months |