Text Size

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

This study has been completed.
Sponsor:
Collaborator:
Stockholm County Council, Sweden
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT00550511
First received: October 29, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Randomized Study Evaluating the Role of Surgeon-Performed Ultrasound in the Management of the Acute Abdomen

Resource links provided by NLM:

MedlinePlus related topics: Abdominal Pain
U.S. FDA Resources

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.
Other Name: US
No Intervention: Control
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, 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

No publications provided by Karolinska Institutet

Additional 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
Study First Received: October 29, 2007
Last Updated: October 29, 2007
Health Authority: Sweden: Regional Ethical Review Board

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

Additional relevant MeSH terms:
Abdomen, Acute
Abdominal Pain
Pain
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on May 16, 2013