The Clinical Acceptability of Unsedated Colonoscopy

NCT01434927 | Completed

• 1 other identifier: 07CE2009
• Study Type: observational
• Target: 964
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonoscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Acceptance rate of unsedated colonoscopy

  up to 8 months

• ODDS ratios for unsedated colonoscopy completion

  up to 8 months

Study Arms (1)

Colonoscopy outpatients

All patients referred to our Unit to undergo colonoscopy for any indication

Procedure: Unsedated colonoscopy

Interventions

Unsedated colonoscopy PROCEDURE

Patients were offered to undergo colonoscopy without routine premedication

Colonoscopy outpatients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• adult outpatients

You may not qualify if:

• previous colorectal surgery
• indication to a bi-directional endoscopy
• indication to a partial examination
• patients' refusal or inability to provide informed consent and
• advanced heart, lung, liver or renal disease (American Society of Anesthesiology risk class III-IV)

Sponsors & Collaborators

• Valduce Hospital: lead

Study Sites (1)

Vadluce Hospital

Como, 22100, Italy

Location

Study Officials

• Franco Radaelli, MD

  Valduce Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD

Study Record Dates

• First Submitted: August 18, 2011
• First Posted: September 15, 2011
• Study Start: October 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: September 15, 2011

Record last verified: 2011-09

Locations

IT (1)