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Randomized Study Evaluating the Role of Surgeon-Performed Ultrasound in the Management of the Acute Abdomen

Primary Purpose

Abdominal Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Surgeon-performed ultrasound
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Abdominal Pain focused on measuring Abdominal pain, ultrasound, surgery, emergency department, diagnostic accuracy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Admitted to emergency ward for abdominal pain
  • 18 years or older

Exclusion Criteria:

  • Pregnancy
  • Condition that has to be taken care of immediately
  • Inability to communicate with the investigator
  • Previously diagnosed abdominal condition
  • Severe drug or alcohol addiction
  • Dementia

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    No Intervention

    Arm Label

    Ultrasound

    Control

    Arm Description

    Surgeon-performed ultrasound as intervention, as a complement to clinical investigation and standardized laboratory testing.

    Control group examined with clinical examination including standardized laboratory tests.

    Outcomes

    Primary Outcome Measures

    Proportion of correct diagnosis

    Secondary Outcome Measures

    Time consumption in emergency department Time to decision about surgical intervention Amount of complementary examinations Amount of hospital admissions Patient satisfaction in the emergency ward and at follow up Consumption of health care

    Full Information

    First Posted
    October 29, 2007
    Last Updated
    October 29, 2007
    Sponsor
    Karolinska Institutet
    Collaborators
    Region Stockholm
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00550511
    Brief Title
    Randomized Study Evaluating the Role of Surgeon-Performed Ultrasound in the Management of the Acute Abdomen
    Official Title
    Randomized Study Evaluating the Role of Surgeon-Performed Ultrasound in the Management of the Acute Abdomen
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    June 2005 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Karolinska Institutet
    Collaborators
    Region Stockholm

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate whether surgeon-performed ultrasound as a supplement to clinical investigation when a patient presents with abdominal pain in the emergency department can improve the management of the patient.
    Detailed Description
    Surgeon-performed ultrasound bedside in the emergency department when a patient presents with abdominal pain is quite common in Continental Europe and USA. It is considered to be implemented at emergency departments all over Sweden. This is the first randomized study performed to evaluate the method. In our study we compare diagnostic accuracy and further management of patients admitted to the emergency department for abdominal pain, with or without examination with surgeon-performed ultrasound bedside.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Abdominal Pain
    Keywords
    Abdominal pain, ultrasound, surgery, emergency department, diagnostic accuracy

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    800 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Ultrasound
    Arm Type
    Other
    Arm Description
    Surgeon-performed ultrasound as intervention, as a complement to clinical investigation and standardized laboratory testing.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Control group examined with clinical examination including standardized laboratory tests.
    Intervention Type
    Radiation
    Intervention Name(s)
    Surgeon-performed ultrasound
    Other Intervention Name(s)
    US
    Intervention Description
    After clinical investigation including standardized laboratory tests the patient in the intervention arm is examined with abdominal ultrasound performed by the study surgeon.
    Primary Outcome Measure Information:
    Title
    Proportion of correct diagnosis
    Time Frame
    6 weeks
    Secondary Outcome Measure Information:
    Title
    Time consumption in emergency department Time to decision about surgical intervention Amount of complementary examinations Amount of hospital admissions Patient satisfaction in the emergency ward and at follow up Consumption of health care
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Admitted to emergency ward for abdominal pain 18 years or older Exclusion Criteria: Pregnancy Condition that has to be taken care of immediately Inability to communicate with the investigator Previously diagnosed abdominal condition Severe drug or alcohol addiction Dementia
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Johanna Adami, ass prof
    Organizational Affiliation
    Karolinska Institutet, Department of Medicine, Clinical epidemiology unit
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Anna Lindelius, MD
    Organizational Affiliation
    Karolinska Institutet, Department of Surgery, Stockholm South General Hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19941671
    Citation
    Lindelius A, Torngren S, Nilsson L, Pettersson H, Adami J. Randomized clinical trial of bedside ultrasound among patients with abdominal pain in the emergency department: impact on patient satisfaction and health care consumption. Scand J Trauma Resusc Emerg Med. 2009 Nov 27;17:60. doi: 10.1186/1757-7241-17-60.
    Results Reference
    derived
    PubMed Identifier
    19625549
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

    Randomized Study Evaluating the Role of Surgeon-Performed Ultrasound in the Management of the Acute Abdomen

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