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

Sponsors and Collaborators:	Karolinska Institutet Stockholm County Council
Information provided by:	Karolinska Institutet
ClinicalTrials.gov Identifier:	NCT00550511

Purpose

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	Intervention
Abdominal Pain	Radiation: Surgeon-performed ultrasound

MedlinePlus related topics: Abdominal Pain Ultrasound

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	Randomized Study Evaluating the Role of Surgeon-Performed Ultrasound in the Management of the Acute Abdomen

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:

Proportion of correct diagnosis [ Time Frame: 6 weeks ]

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 [ Time Frame: 2 years ]

Enrollment:	800
Study Start Date:	February 2004
Study Completion Date:	June 2005

Arms	Assigned Interventions
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.
Control: No Intervention Control group examined with clinical examination including standardized laboratory tests.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00550511

Sponsors and Collaborators

Karolinska Institutet

Stockholm County Council

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

Study ID Numbers:	ULABD-1
Study First Received:	October 29, 2007
Last Updated:	October 29, 2007
ClinicalTrials.gov Identifier:	NCT00550511
Health Authority:	Sweden: Regional Ethical Review Board

Keywords provided by Karolinska Institutet:

Abdominal pain
ultrasound
surgery
emergency department
diagnostic accuracy

Study placed in the following topic categories:

Signs and Symptoms
Abdomen, Acute
Signs and Symptoms, Digestive

Abdominal Pain
Emergencies
Pain

ClinicalTrials.gov processed this record on January 15, 2009