NCT02469935

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 12, 2015

Completed
Last Updated

June 12, 2015

Status Verified

June 1, 2015

Enrollment Period

1.1 years

First QC Date

June 3, 2015

Last Update Submit

June 9, 2015

Conditions

Gallstones

Keywords

ValidationSurgeon-performed ultrasoundGallstones

Outcome Measures

Primary Outcomes (1)

  • Accuracy of surgeon-performed ultrasound

    Compared to radiologist-performed ultrasound

    13 months

Interventions

ultrasoundPROCEDURE

surgeon-performed ultrasound

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients referred to the radiology department for an abdominal ultrasound.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet Södersjukhuset (South General Hospital)

Stockholm, Stockholm County, S-11883, Sweden

Location

Related Publications (18)

  • 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. doi: 10.1016/0735-6757(95)90204-X.

    PMID: 7755822RESULT

  • 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. doi: 10.1056/NEJM198006053022303.

    PMID: 7366693RESULT

  • 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. doi: 10.1046/j.1365-2168.2002.02297.x.

    PMID: 12390381RESULT

  • Rozycki GS. Surgeon-performed ultrasound: its use in clinical practice. Ann Surg. 1998 Jul;228(1):16-28. doi: 10.1097/00000658-199807000-00004.

    PMID: 9671062RESULT

  • Moore CL, Copel JA. Point-of-care ultrasonography. N Engl J Med. 2011 Feb 24;364(8):749-57. doi: 10.1056/NEJMra0909487. No abstract available.

    PMID: 21345104RESULT

  • Allemann F, Cassina P, Rothlin M, Largiader F. Ultrasound scans done by surgeons for patients with acute abdominal pain: a prospective study. Eur J Surg. 1999 Oct;165(10):966-70. doi: 10.1080/110241599750008099.

    PMID: 10574106RESULT

  • Lindelius A, Torngren 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.

    PMID: 19625549RESULT

  • 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. doi: 10.1016/s0002-9610(99)00225-1.

    PMID: 10670856RESULT

  • 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.

    PMID: 15929534RESULT

  • 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):2573-81.

    PMID: 7979854RESULT

  • 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.amjsurg.2012.02.017. Epub 2012 Jun 29.

    PMID: 22748292RESULT

  • Lindelius A, Torngren S, Sonden 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.

    PMID: 18660395RESULT

  • Newcombe RG. Two-sided confidence intervals for the single proportion: comparison of seven methods. Stat Med. 1998 Apr 30;17(8):857-72. doi: 10.1002/(sici)1097-0258(19980430)17:83.0.co;2-e.

    PMID: 9595616RESULT

  • Irkorucu O, Reyhan E, Erdem H, Cetinkunar 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.

    PMID: 23273179RESULT

  • 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.

    PMID: 19561694RESULT

  • 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. No abstract available.

    PMID: 22208845RESULT

  • 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.

    PMID: 18439787RESULT

  • Gustafsson C, Lindelius A, Torngren S, Jarnbert-Pettersson H, Sonden A. Surgeon-Performed Ultrasound in Diagnosing Acute Cholecystitis and Appendicitis. World J Surg. 2018 Nov;42(11):3551-3559. doi: 10.1007/s00268-018-4673-z.

    PMID: 29882098DERIVED

Related Links

MeSH Terms

Conditions

Gallstones

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

CholelithiasisBiliary Tract DiseasesDigestive System DiseasesCholecystolithiasisGallbladder DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Anders Sonden, MD. PhD

    Karolinska Institutet Södersjukhuset

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

June 3, 2015

First Posted

June 12, 2015

Study Start

October 1, 2011

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

June 12, 2015

Record last verified: 2015-06

Locations

SE(1)