Randomized Study Evaluating the Role of Surgeon-Performed Ultrasound in the Management of the Acute Abdomen
Primary Purpose
Abdominal Pain
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Surgeon-performed ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Abdominal Pain focused on measuring Abdominal pain, ultrasound, surgery, emergency department, diagnostic accuracy
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
Ultrasound
Control
Arm Description
Surgeon-performed ultrasound as intervention, as a complement to clinical investigation and standardized laboratory testing.
Control group examined with clinical examination including standardized laboratory tests.
Outcomes
Primary Outcome Measures
Proportion of correct diagnosis
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
Full Information
NCT ID
NCT00550511
First Posted
October 29, 2007
Last Updated
October 29, 2007
Sponsor
Karolinska Institutet
Collaborators
Region Stockholm
1. Study Identification
Unique Protocol Identification Number
NCT00550511
Brief Title
Randomized Study Evaluating the Role of Surgeon-Performed Ultrasound in the Management of the Acute Abdomen
Official Title
Randomized Study Evaluating the Role of Surgeon-Performed Ultrasound in the Management of the Acute Abdomen
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Karolinska Institutet
Collaborators
Region Stockholm
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Pain
Keywords
Abdominal pain, ultrasound, surgery, emergency department, diagnostic accuracy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
800 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ultrasound
Arm Type
Other
Arm Description
Surgeon-performed ultrasound as intervention, as a complement to clinical investigation and standardized laboratory testing.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control group examined with clinical examination including standardized laboratory tests.
Intervention Type
Radiation
Intervention Name(s)
Surgeon-performed ultrasound
Other Intervention Name(s)
US
Intervention Description
After clinical investigation including standardized laboratory tests the patient in the intervention arm is examined with abdominal ultrasound performed by the study surgeon.
Primary Outcome Measure Information:
Title
Proportion of correct diagnosis
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johanna Adami, ass prof
Organizational Affiliation
Karolinska Institutet, Department of Medicine, Clinical epidemiology unit
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anna Lindelius, MD
Organizational Affiliation
Karolinska Institutet, Department of Surgery, Stockholm South General Hospital
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
19941671
Citation
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.
Results Reference
derived
PubMed Identifier
19625549
Citation
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.
Results Reference
derived
Learn more about this trial
Randomized Study Evaluating the Role of Surgeon-Performed Ultrasound in the Management of the Acute Abdomen
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