Gallstones Clinical Trial
Official title:
Accuracy of Surgeon-performed Ultrasound in Detecting Gallstones - a Validation Study
Verified date | June 2015 |
Source | Karolinska Institutet |
Contact | n/a |
Is FDA regulated | No |
Health authority | Sweden: Regional Ethical Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 300 |
Est. completion date | November 2012 |
Est. primary completion date | November 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Sweden | Karolinska Institutet Södersjukhuset (South General Hospital) | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet |
Sweden,
Ahmad S, Zafar A, Ahmad M, Ghafoor A, Malik E, Ali A, Qazi UA. Accuracy of surgeon-performed abdominal utrasound for gallstones. J Ayub Med Coll Abbottabad. 2005 Jan-Mar;17(1):70-1. — View Citation
Allemann F, Cassina P, Röthlin M, Largiadèr F. Ultrasound scans done by surgeons for patients with acute abdominal pain: a prospective study. Eur J Surg. 1999 Oct;165(10):966-70. — View Citation
Carroll PJ, Gibson D, El-Faedy O, Dunne C, Coffey C, Hannigan A, Walsh SR. Surgeon-performed ultrasound at the bedside for the detection of appendicitis and gallstones: systematic review and meta-analysis. Am J Surg. 2013 Jan;205(1):102-8. doi: 10.1016/j. — View Citation
Cooperberg PL, Burhenne HJ. Real-time ultrasonography. Diagnostic technique of choice in calculous gallbladder disease. N Engl J Med. 1980 Jun 5;302(23):1277-9. — View Citation
Fang R, Pilcher JA, Putnam AT, Smith T, Smith DL. Accuracy of surgeon-performed gallbladder ultrasound. Am J Surg. 1999 Dec;178(6):475-9. — View Citation
Gaspari RJ, Dickman E, Blehar D. Learning curve of bedside ultrasound of the gallbladder. J Emerg Med. 2009 Jul;37(1):51-6. doi: 10.1016/j.jemermed.2007.10.070. Epub 2008 Apr 25. — View Citation
Irkorucu O, Reyhan E, Erdem H, Cetinkünar S, Deger KC, Yilmaz C. Accuracy of surgeon-performed gallbladder ultrasound in identification of acute cholecystitis. J Invest Surg. 2013 Apr;26(2):85-8. doi: 10.3109/08941939.2012.697977. Epub 2012 Dec 28. — View Citation
Kell MR, Aherne NJ, Coffey C, Power CP, Kirwan WO, Redmond HP. Emergency surgeon-performed hepatobiliary ultrasonography. Br J Surg. 2002 Nov;89(11):1402-4. — View Citation
Lindelius A, Törngren S, Pettersson H, Adami J. Role of surgeon-performed ultrasound on further management of patients with acute abdominal pain: a randomised controlled clinical trial. Emerg Med J. 2009 Aug;26(8):561-6. doi: 10.1136/emj.2008.062067. — View Citation
Lindelius A, Törngren S, Sondén A, Pettersson H, Adami J. Impact of surgeon-performed ultrasound on diagnosis of abdominal pain. Emerg Med J. 2008 Aug;25(8):486-91. doi: 10.1136/emj.2007.052142. — View Citation
Moore CL, Copel JA. Point-of-care ultrasonography. N Engl J Med. 2011 Feb 24;364(8):749-57. doi: 10.1056/NEJMra0909487. Review. — View Citation
Newcombe RG. Two-sided confidence intervals for the single proportion: comparison of seven methods. Stat Med. 1998 Apr 30;17(8):857-72. — View Citation
Powers RD, Guertler AT. Abdominal pain in the ED: stability and change over 20 years. Am J Emerg Med. 1995 May;13(3):301-3. — View Citation
Rozycki GS. Surgeon-performed ultrasound: its use in clinical practice. Ann Surg. 1998 Jul;228(1):16-28. Review. — View Citation
Scruggs W, Fox JC, Potts B, Zlidenny A, McDonough J, Anderson CL, Larson J, Barajas G, Langdorf MI. Accuracy of ED Bedside Ultrasound for Identification of gallstones: retrospective analysis of 575 studies. West J Emerg Med. 2008 Jan;9(1):1-5. Erratum in: — View Citation
Shea JA, Berlin JA, Escarce JJ, Clarke JR, Kinosian BP, Cabana MD, Tsai WW, Horangic N, Malet PF, Schwartz JS, et al. Revised estimates of diagnostic test sensitivity and specificity in suspected biliary tract disease. Arch Intern Med. 1994 Nov 28;154(22) — View Citation
Shepherd AE, Gogalniceanu P, Kashef E, Purkayastha S, Zacharakis E, Paraskeva PA. Surgeon-performed ultrasound--a call for consensus and standardization. J Surg Educ. 2012 Jan-Feb;69(1):132-3. doi: 10.1016/j.jsurg.2011.09.006. Epub 2011 Nov 3. — View Citation
* Note: There are 17 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Accuracy of surgeon-performed ultrasound | Compared to radiologist-performed ultrasound | 13 months | No |
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