The Clinical Acceptability of Unsedated Colonoscopy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Unsedated Colonoscopy: An Option For Some But Not For All

Conditions
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Colonoscopy

Intervention / Treatment
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* Procedure: Unsedated colonoscopy
* Procedure: Unsedated colonoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult outpatients Exclusion Criteria: previous colorectal surgery indication to a bi-directional endoscopy indication to a partial examination patients' refusal or inability to provide informed consent and advanced heart, lung, liver or renal disease (American Society of Anesthesiology risk class III-IV)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Colonoscopy outpatients<br>All patients referred to our Unit to undergo colonoscopy for any indication | Procedure: Unsedated colonoscopy<br>* Patients were offered to undergo colonoscopy without routine premedication<br>Procedure: Unsedated colonoscopy<br>* Patients were offered to undergo unsedated procedure. Their demographics and clinical data were recorded<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |