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Acute Abdomen in Adults- a Prospective Study on Emergency Department Admissions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03074084
Recruitment Status : Recruiting
First Posted : March 8, 2017
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Tampere University Hospital

Study Description
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Brief Summary:
This is a non-randomized, prospective, population-based, single-center study designed to evaluate conditions resulting emergency admission in patients with abdominal pain. Furthermore, we are interested in how many patients are discharged with "non-specific abdominal pain" but later readmitted and diagnosed with a specific diagnosis.

Condition or disease
Abdominal Pain

Detailed Description:
1000 adult patients with acute abdominal pain will be recruited at Tampere University Hospital Emergency department. The patients will fill in a questionaire about the symptoms and their duration. A urine sample will be collected for polyamine molecule analysis with an electronic nose. At later stage of the study, a serum sample for coeliac tests will be collected. Patient outcome will be obtained during the hospital stay, at one-month after discharge and at one year.
Study Design
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Acute Abdomen in Adults- a Prospective Study on Causes of Abdominal Pain Leading to Emergency Department Admission in Tampere University Hospital
Study Start Date : June 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abdominal Pain

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Number of patients with specific diagnose [ Time Frame: One month ]
    Population based analysis of incidence of diseases


Secondary Outcome Measures :
  1. Number of patients misdiagnosed in emergency department and requiring readmission [ Time Frame: One month ]
  2. Number of participants with treatment related adverse events [ Time Frame: One month ]
  3. Diagnostic accuracy of polyamine molecule analysis [ Time Frame: One month ]
  4. Number of patients with undiagnosed coeliac disease [ Time Frame: One month ]

Biospecimen Retention:   Samples Without DNA
urine sample, blood sample

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
the adult patients with abdominal pain admitted to the emergency department are included. One thousand patients from Tampere district will be chosen for analysis.
Criteria

Inclusion Criteria:

All adult patients with abdominal pain.

Exclusion Criteria:

Under the age of 18 years

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03074084


Contacts
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Contact: Mika T Ukkonen, MD, PhD, MEcon +358443454523 mika.ukkonen@fimnet.fi
Contact: Leena M Saaristo, MD +358405030201 leena.saaristo@fimnet.fi

Locations
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Finland
Tampere University Hospital Recruiting
Tampere, Finland
Contact: Satu-Liisa K Pauniaho, MD, PhD    +358505386783    satu-liisa.pauniaho@pshp.fi   
Contact: Mika T Ukkonen, MD, PhD, MEcon    +358443454523    mika.ukkonen@fimnet.fi   
Sponsors and Collaborators
Tampere University Hospital
Investigators
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Principal Investigator: Satu-Liisa K Pauniaho, MD, PhD Tampere University Hospital, Finland
More Information
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Responsible Party: Tampere University Hospital
ClinicalTrials.gov Identifier: NCT03074084    
Other Study ID Numbers: R16006
First Posted: March 8, 2017    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Keywords provided by Tampere University Hospital:
abdominal pain
adult
emergency department
electronic nose
celiac disease
Additional relevant MeSH terms:
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Emergencies
Abdominal Pain
Abdomen, Acute
Disease Attributes
Pathologic Processes
 Pain
Neurologic Manifestations
Signs and Symptoms
Signs and Symptoms, Digestive