Colonoscopy
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREUnsedated colonoscopy
Patients were offered to undergo colonoscopy without routine premedication
Sponsors
Valduce Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* adult outpatients
Exclusion criteria
1. previous colorectal surgery 2. indication to a bi-directional endoscopy 3. indication to a partial examination 4. patients' refusal or inability to provide informed consent and 5. advanced heart, lung, liver or renal disease (American Society of Anesthesiology risk class III-IV)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ODDS ratio for unsedated colonoscopy acceptance | up to 8 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptance rate of unsedated colonoscopy | up to 8 months | Proportion of patients accepting to attempt colonoscopy without routine premedication |
| ODDS ratios for unsedated colonoscopy completion | up to 8 months | 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 |
Countries
Italy
Outcome results
None listed