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Completed

NCT Number: NCT01434927

The Clinical Acceptability of Unsedated Colonoscopy

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.

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Key information

Conditions

Colonoscopy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Vadluce Hospital

Como, 22100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adult outpatients

Exclusion criteria

  • 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)

Treatment and study plan

Unsedated colonoscopy

Procedure

Patients were offered to undergo colonoscopy without routine premedication

Primary outcomes

  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 outcomes

  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

Interested in participating?

Completed

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Sponsors and collaborators

Lead sponsor

Valduce Hospital

Other

Registry information

Official study title

Unsedated Colonoscopy: An Option For Some But Not For All

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 15, 2011
Registry last updated
Sep 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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