The Clinical Acceptability of Unsedated Colonoscopy

NCT ID: NCT01434927

Last Updated: 2011-09-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 964 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2010-04-30

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.

Conditions

Colonoscopy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Colonoscopy outpatients

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

Unsedated colonoscopy

Intervention Type: PROCEDURE

Patients were offered to undergo colonoscopy without routine premedication

Unsedated colonoscopy

Intervention Type: PROCEDURE

Patients were offered to undergo unsedated procedure. Their demographics and clinical data were recorded

Interventions

Unsedated colonoscopy

Patients were offered to undergo colonoscopy without routine premedication

Intervention Type: PROCEDURE

Unsedated colonoscopy

Patients were offered to undergo unsedated procedure. Their demographics and clinical data were recorded

Intervention Type: PROCEDURE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Valduce Hospital

OTHER

Sponsor Role: lead

Responsible Party

Franco Radaelli

Principal Investigator, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Franco Radaelli, MD

Role: PRINCIPAL_INVESTIGATOR

Valduce Hospital

Locations

Vadluce Hospital

Como, , Italy

Countries

Italy

Other Identifiers

07CE2009

Identifier Type: -

Identifier Source: org_study_id