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

NCT00550511 | Completed DMC

• 1 other identifier: ULABD-1
• Study Type: interventional
• Target: 800
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Abdominal Pain

Keywords

Abdominal pain; ultrasound; surgery; emergency department; diagnostic accuracy

Outcome Measures

Primary Outcomes (1)

• Proportion of correct diagnosis

  6 weeks

Secondary Outcomes (1)

• 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

Study Arms (2)

Ultrasound

OTHER

Surgeon-performed ultrasound as intervention, as a complement to clinical investigation and standardized laboratory testing.

Radiation: Surgeon-performed ultrasound

Control

NO INTERVENTION

Control group examined with clinical examination including standardized laboratory tests.

Interventions

Surgeon-performed ultrasound RADIATION

After clinical investigation including standardized laboratory tests the patient in the intervention arm is examined with abdominal ultrasound performed by the study surgeon.

Also known as: US

Ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admitted to emergency ward for abdominal pain
• years or older

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator

Related Publications (2)

• Lindelius A, Torngren S, Nilsson L, Pettersson H, Adami J. Randomized clinical trial of bedside ultrasound among patients with abdominal pain in the emergency department: impact on patient satisfaction and health care consumption. Scand J Trauma Resusc Emerg Med. 2009 Nov 27;17:60. doi: 10.1186/1757-7241-17-60.

  PMID: 19941671 DERIVED

• Lindelius A, Torngren S, Pettersson H, Adami J. Role of surgeon-performed ultrasound on further management of patients with acute abdominal pain: a randomised controlled clinical trial. Emerg Med J. 2009 Aug;26(8):561-6. doi: 10.1136/emj.2008.062067.

  PMID: 19625549 DERIVED

MeSH Terms

Conditions

Abdominal Pain; Emergencies

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Disease Attributes; Pathologic Processes

Study Officials

• Johanna Adami, ass prof

  Karolinska Institutet, Department of Medicine, Clinical epidemiology unit

  PRINCIPAL INVESTIGATOR

• Anna Lindelius, MD

  Karolinska Institutet, Department of Surgery, Stockholm South General Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 29, 2007
• First Posted: October 30, 2007
• Study Start: February 1, 2004
• Study Completion: June 1, 2005
• Last Updated: October 30, 2007

Record last verified: 2007-10