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

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ClinicalTrials.gov Identifier: NCT00550511
Recruitment Status : Completed
First Posted : October 30, 2007
Last Update Posted : October 30, 2007
Sponsor:
Collaborator:
Information provided by:

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.

Condition or disease Intervention/treatment
Abdominal Pain Radiation: Surgeon-performed ultrasound

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Randomized Study Evaluating the Role of Surgeon-Performed Ultrasound in the Management of the Acute Abdomen
Study Start Date : February 2004
Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Ultrasound
Surgeon-performed ultrasound as intervention, as a complement to clinical investigation and standardized laboratory testing.
Radiation: Surgeon-performed ultrasound
After clinical investigation including standardized laboratory tests the patient in the intervention arm is examined with abdominal ultrasound performed by the study surgeon.
Other Name: US
No Intervention: Control
Control group examined with clinical examination including standardized laboratory tests.


Outcome Measures

Primary Outcome Measures :
  1. Proportion of correct diagnosis [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

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): NCT00550511


Sponsors and Collaborators
Karolinska Institutet
Stockholm County Council, Sweden
Investigators
Principal Investigator: Johanna Adami, ass prof Karolinska Institutet, Department of Medicine, Clinical epidemiology unit
Study Director: Anna Lindelius, MD Karolinska Institutet, Department of Surgery, Stockholm South General Hospital
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00550511     History of Changes
Other Study ID Numbers: ULABD-1
First Posted: October 30, 2007    Key Record Dates
Last Update Posted: October 30, 2007
Last Verified: October 2007

Keywords provided by Karolinska Institutet:
Abdominal pain
ultrasound
surgery
emergency department
diagnostic accuracy

Additional relevant MeSH terms:
Abdominal Pain
Abdomen, Acute
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Signs and Symptoms, Digestive