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The Clinical Acceptability of Unsedated Colonoscopy

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ClinicalTrials.gov Identifier: NCT01434927
Recruitment Status : Completed
First Posted : September 15, 2011
Last Update Posted : September 15, 2011
Sponsor:
Information provided by (Responsible Party):
Franco Radaelli, Valduce Hospital

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.

Condition or disease Intervention/treatment
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
Actual Enrollment : 964 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Unsedated Colonoscopy: An Option For Some But Not For All
Study Start Date : October 2009
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

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



Primary Outcome Measures :
  1. ODDS ratio for unsedated colonoscopy acceptance [ Time Frame: up to 8 months ]
    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 :
  1. Acceptance rate of unsedated colonoscopy [ Time Frame: up to 8 months ]
    Proportion of patients accepting to attempt colonoscopy without routine premedication

  2. ODDS ratios for unsedated colonoscopy completion [ Time Frame: up to 8 months ]
    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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01434927


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

Responsible Party: Franco Radaelli, Principal Investigator, MD, Valduce Hospital
ClinicalTrials.gov Identifier: NCT01434927     History of Changes
Other Study ID Numbers: 07CE2009
First Posted: September 15, 2011    Key Record Dates
Last Update Posted: September 15, 2011
Last Verified: September 2011