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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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.

Detailed Summary:

Enrolment of patients:

Three hundred patients, with an acute or elective referral to the radiology department at Stockholm South General Hospital, Sweden, for any diagnostic abdominal US examination, including both patients admitted to in-hospital care and out-patients, were prospectively enrolled between October 2011 and November 2012. Eligible patients were identified in the radiology department by a study surgeon and informed consent was obtained. Six US educated surgeons participated in the enrolment of patients. Exclusion criteria were age <18 years or inability to communicate with the examiner. Referrals concerning metastases of the liver or contrast-enhanced examinations were considered not suitable for the study and were also excluded. The surgeons examined patients consecutively if time was available, but mostly they didn't have time to examine every patient referred per day, hence a certain prioritisation between referrals was done.

Data collection:

Enrolled patients received one US examination by the study surgeon as well as the standard US examination by the on-duty radiologist. In a majority of cases the two examinations were performed consecutively and the time interval between the surgeon-performed US and radiologist-performed US never exceeded 24 hours. The surgeon's examination took place either before or right after the radiologist's examination. The examining surgeon and radiologist were blinded to each other's findings. The surgeon's US examination followed a standardised protocol, which included a full abdominal scan, regardless of the nature of the referral. The presence of gallstones was marked as a 'yes' (positive finding, regardless of number or size) or 'no' (negative finding) by the surgeon. In cases where a full abdominal scan could not be per
Sponsor: Karolinska Institutet

Current Primary Outcome: Accuracy of surgeon-performed ultrasound [ Time Frame: 13 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Karolinska Institutet

Dates:
Date Received: June 3, 2015
Date Started: October 2011
Date Completion:
Last Updated: June 9, 2015
Last Verified: June 2015