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The Clinical Acceptability of Unsedated Colonoscopy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Franco Radaelli, Valduce Hospital
ClinicalTrials.gov Identifier:
NCT01434927
First received: August 18, 2011
Last updated: September 13, 2011
Last verified: September 2011
History of Changes
  Purpose

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.


Condition Intervention
Colonoscopy
 Procedure: Unsedated colonoscopy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Unsedated Colonoscopy: An Option For Some But Not For All

Resource links provided by NLM:

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Further study details as provided by Valduce Hospital:

Primary Outcome Measures:
  • ODDS ratio for unsedated colonoscopy acceptance [ Time Frame: up to 8 months ] [ Designated as safety issue: No ]
    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:
  • Acceptance rate of unsedated colonoscopy [ Time Frame: up to 8 months ] [ Designated as safety issue: No ]
    Proportion of patients accepting to attempt colonoscopy without routine premedication

  • ODDS ratios for unsedated colonoscopy completion [ Time Frame: up to 8 months ] [ Designated as safety issue: No ]
    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


Enrollment: 964
Study Start Date: October 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01434927

Locations
Italy
Vadluce Hospital
Como, Italy, 22100
Sponsors and Collaborators
Valduce Hospital
Investigators
Principal Investigator: Franco Radaelli, MD Valduce Hospital
  More Information

No publications provided

Responsible Party: Franco Radaelli, Principal Investigator, MD, Valduce Hospital
ClinicalTrials.gov Identifier: NCT01434927     History of Changes
Other Study ID Numbers: 07CE2009
Study First Received: August 18, 2011
Last Updated: September 13, 2011
Health Authority: Italy: Ethics Committee

ClinicalTrials.gov processed this record on May 22, 2013