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Accuracy of Surgeon-performed Ultrasound in Detecting Gallstones - a Validation Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02469935
Recruitment Status : Completed
First Posted : June 12, 2015
Last Update Posted : June 12, 2015
Sponsor:
Information provided by (Responsible Party):
Camilla Gustafsson, Karolinska Institutet

Brief Summary:

Aims: To prospectively investigate the accuracy of surgeon-performed ultrasound for the detection of gallstones.

Methods: 179 adult patients, with an acute or elective referral for an abdominal ultrasound examination, were examined with a right upper quadrant ultrasound scan by a radiologist as well as surgeon. The surgeons had undergone a four-week long education in ultrasound before participating in the study. Ultrasound findings of the surgeon were compared to those of the radiologist, using radiologist-performed ultrasound as reference standard.


Condition or disease Intervention/treatment
Gallstones Procedure: ultrasound

Show Show detailed description

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Study Type : Observational
Actual Enrollment : 300 participants
Time Perspective: Prospective
Official Title: Accuracy of Surgeon-performed Ultrasound in Detecting Gallstones - a Validation Study
Study Start Date : October 2011
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: ultrasound
    surgeon-performed ultrasound


Primary Outcome Measures :
  1. Accuracy of surgeon-performed ultrasound [ Time Frame: 13 months ]
    Compared to radiologist-performed ultrasound



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients referred to the radiology department for an abdominal ultrasound.
Criteria

Inclusion Criteria:

  • Patients referred to the radiology department for an abdominal ultrasound
  • Age > 18 years

Exclusion Criteria:

  • Inability to communicate with the examiner
  • Referral for intervention
  • Metastasis screening
  • Referrals concerning contrast enhanced examinations

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): NCT02469935


Locations
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Sweden
Karolinska Institutet Södersjukhuset (South General Hospital)
Stockholm, Sweden, S-11883
Sponsors and Collaborators
Karolinska Institutet
Investigators
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Principal Investigator: Anders Sonden, MD. PhD Karolinska Institutet Södersjukhuset
Additional Information:
Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Camilla Gustafsson, PhD student, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02469935    
Other Study ID Numbers: 2011/1025-31/1
First Posted: June 12, 2015    Key Record Dates
Last Update Posted: June 12, 2015
Last Verified: June 2015
Keywords provided by Camilla Gustafsson, Karolinska Institutet:
Validation
Surgeon-performed ultrasound
Gallstones
Additional relevant MeSH terms:
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Gallstones
Cholelithiasis
Cholecystolithiasis
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical