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

NCT ID: NCT00550511

Last Updated: 2007-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2005-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Abdominal Pain

Keywords

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Abdominal pain ultrasound surgery emergency department diagnostic accuracy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Ultrasound

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

Group Type OTHER

Surgeon-performed ultrasound

Intervention Type RADIATION

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

Control

Control group examined with clinical examination including standardized laboratory tests.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type RADIATION

Other Intervention Names

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US

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Stockholm

OTHER_GOV

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Principal Investigators

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Johanna Adami, ass prof

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet, Department of Medicine, Clinical epidemiology unit

Anna Lindelius, MD

Role: STUDY_DIRECTOR

Karolinska Institutet, Department of Surgery, Stockholm South General Hospital

References

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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.

Reference Type DERIVED
PMID: 19941671 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19625549 (View on PubMed)

Other Identifiers

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ULABD-1

Identifier Type: -

Identifier Source: org_study_id