The Clinical Acceptability of Unsedated Colonoscopy

Completed

• Conditions: Colonoscopy
• Interventions: Procedure: Unsedated colonoscopy

• Registration Number: NCT01434927
• Lead Sponsor: Valduce Hospital

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.

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Study First Submitted: 2011-08-18
• Status Verified: 2011-09
• Study First Submitted QC: 2011-09-13
• Last Update Submitted: 2011-09-13
• Study First Posted: 2011-09-15
• Last Update Posted: 2011-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 964

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Colonoscopy outpatients	Unsedated colonoscopy	All patients referred to our Unit to undergo colonoscopy for any indication

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Vadluce Hospital; 🇮🇹 Como, Italy