The Clinical Acceptability of Unsedated Colonoscopy

Colonoscopy Clinical Trial

Official title:

Unsedated Colonoscopy: An Option For Some But Not For All

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01434927
• Other study ID #: 07CE2009
• Status: Completed
• Phase: N/A
• First received: August 18, 2011
• Last updated: September 13, 2011
• Start date: October 2009
• Est. completion date: April 2010

Study information

• Verified date: September 2011
• Source: Valduce Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 964
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colonoscopy

Intervention

Procedure:
• Unsedated colonoscopy
Patients were offered to undergo colonoscopy without routine premedication
• Unsedated colonoscopy
Patients were offered to undergo unsedated procedure. Their demographics and clinical data were recorded

Locations

Country	Name	City	State
Italy	Vadluce Hospital	Como

Sponsors (1)

Lead Sponsor	Collaborator
Valduce Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Acceptance rate of unsedated colonoscopy	Proportion of patients accepting to attempt colonoscopy without routine premedication	up to 8 months	No
Secondary	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	No