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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Abdominal Pain

Intervention / Treatment
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* Radiation: Surgeon-performed ultrasound


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Ultrasound<br>Surgeon-performed ultrasound as intervention, as a complement to clinical investigation and standardized laboratory testing. | Radiation: Surgeon-performed ultrasound<br>* After clinical investigation including standardized laboratory tests the patient in the intervention arm is examined with abdominal ultrasound performed by the study surgeon.<br>* Other names: US;|
| No Intervention: Control<br>Control group examined with clinical examination including standardized laboratory tests. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of correct diagnosis |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abdominal pain, ultrasound, surgery, emergency department, diagnostic accuracy