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

August 18, 2011
September 13, 2011
October 2009
April 2010   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01434927 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Colonoscopy
  • 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
Colonoscopy outpatients
All patients referred to our Unit to undergo colonoscopy for any indication
Interventions:
  • Procedure: Unsedated colonoscopy
  • Procedure: Unsedated colonoscopy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
964
April 2010
April 2010   (final data collection date for primary outcome measure)

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)
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01434927
07CE2009
No
Franco Radaelli, Valduce Hospital
Valduce Hospital
Not Provided
Principal Investigator: Franco Radaelli, MD Valduce Hospital
Valduce Hospital
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP