An observational study in Colonoscopy, sponsored by Valduce Hospital. Completed at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2011-09-15.
Sponsored by Valduce Hospital · Observational
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.
Valduce Hospital is the lead sponsor of 26 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
all consecutive 18-80 year-old outpatients presenting to undergo open-access colonoscopy for routine indications were considered eligible to enter the study.
Exclusion Criteria:
All patients referred to our Unit to undergo colonoscopy for any indication
Procedure: Unsedated colonoscopy
Patients were offered to undergo colonoscopy without routine premedication
Patients were offered to undergo unsedated procedure. Their demographics and clinical data were recorded
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
Time frame: up to 8 months
Acceptance rate of unsedated colonoscopy
Proportion of patients accepting to attempt colonoscopy without routine premedication
Time frame: 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
Time frame: up to 8 months
This study is completed, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.
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Valduce Hospital