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

Abdominal Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00550511
• Other study ID #: ULABD-1
• 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
• 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

• Abdomen, Acute
• Abdominal Pain

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