NCT01434927

The Clinical Acceptability of Unsedated Colonoscopy

Unsedated Colonoscopy: An Option For Some But Not For All

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 964 (actual)
• Sponsor: Valduce Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colonoscopy

Interventions

Type	Name	Description
PROCEDURE	Unsedated colonoscopy	Patients were offered to undergo colonoscopy without routine premedication
PROCEDURE	Unsedated colonoscopy	Patients were offered to undergo unsedated procedure. Their demographics and clinical data were recorded

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2011-09-15
• Last updated: 2011-09-15

Locations

1 site across 1 country: Italy