The Clinical Acceptability of Unsedated Colonoscopy

Unsedated Colonoscopy: An Option For Some But Not For All

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.

Study Overview

• Status: Completed
• Conditions: Colonoscopy
• Intervention / Treatment: Procedure: Unsedated colonoscopy; Procedure: Unsedated colonoscopy

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 Type: Observational
• Enrollment (Actual): 964

Contacts and Locations

Study Locations

• Italy
  • Como, Italy, 22100
    • Vadluce Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

all consecutive 18-80 year-old outpatients presenting to undergo open-access colonoscopy for routine indications were considered eligible to enter the study.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Colonoscopy outpatients; All patients referred to our Unit to undergo colonoscopy for any indication	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Valduce Hospital
• Investigators: Principal Investigator: Franco Radaelli, MD, Valduce Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: August 18, 2011
• First Submitted That Met QC Criteria: September 13, 2011
• First Posted (Estimate): September 15, 2011

Study Record Updates

• Last Update Posted (Estimate): September 15, 2011
• Last Update Submitted That Met QC Criteria: September 13, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Other Study ID Numbers: 07CE2009