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| Tracking Information | |||||||||
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| First Received Date ICMJE | October 29, 2007 | ||||||||
| Last Updated Date | October 29, 2007 | ||||||||
| Start Date ICMJE | February 2004 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE |
Proportion of correct diagnosis [ Time Frame: 6 weeks ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Randomized Study Evaluating the Role of Surgeon-Performed Ultrasound in the Management of the Acute Abdomen | ||||||||
| Official Title ICMJE | Randomized Study Evaluating the Role of Surgeon-Performed Ultrasound in the Management of the Acute Abdomen | ||||||||
| 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. |
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| 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. |
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| Study Phase | |||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Diagnostic, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study | ||||||||
| Condition ICMJE | Abdominal Pain | ||||||||
| Intervention ICMJE | Radiation: Surgeon-performed ultrasound | ||||||||
| Study Arms / Comparison Groups |
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| Publications * | Lindelius A, Törngren 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. | ||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 800 | ||||||||
| Completion Date | June 2005 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | |||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00550511 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | ULABD-1 | ||||||||
| Study Sponsor ICMJE | Karolinska Institutet | ||||||||
| Collaborators ICMJE | Stockholm County Council | ||||||||
| Investigators ICMJE |
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| Information Provided By | Karolinska Institutet | ||||||||
| Verification Date | October 2007 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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