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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00550511
Other study ID # ULABD-1
Secondary ID
Status Completed
Phase N/A
First received October 29, 2007
Last updated October 29, 2007
Start date February 2004
Est. completion date June 2005

Study information

Verified date October 2007
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority Sweden: Regional Ethical Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 800
Est. completion date June 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Karolinska Institutet Stockholm County Council, Sweden

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of correct diagnosis 6 weeks
Secondary 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
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