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

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ClinicalTrials.gov Identifier: NCT03074084
Recruitment Status : Recruiting
First Posted : March 8, 2017
Last Update Posted : March 6, 2020
Sponsor:
Information provided by (Responsible Party):
Tampere University Hospital

Tracking Information
First Submitted Date October 20, 2016
First Posted Date March 8, 2017
Last Update Posted Date March 6, 2020
Study Start Date June 2016
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 3, 2017)
Number of patients with specific diagnose [ Time Frame: One month ]
Population based analysis of incidence of diseases
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 3, 2017)
  • Number of patients misdiagnosed in emergency department and requiring readmission [ Time Frame: One month ]
  • Number of participants with treatment related adverse events [ Time Frame: One month ]
  • Diagnostic accuracy of polyamine molecule analysis [ Time Frame: One month ]
  • Number of patients with undiagnosed coeliac disease [ Time Frame: One month ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Acute Abdomen in Adults- a Prospective Study on Emergency Department Admissions
Official Title Acute Abdomen in Adults- a Prospective Study on Causes of Abdominal Pain Leading to Emergency Department Admission in Tampere University Hospital
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
urine sample, blood sample
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.
Condition Abdominal Pain
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 3, 2017)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2025
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

All adult patients with abdominal pain.

Exclusion Criteria:

Under the age of 18 years

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Mika T Ukkonen, MD, PhD, MEcon +358443454523 mika.ukkonen@fimnet.fi
Contact: Leena M Saaristo, MD +358405030201 leena.saaristo@fimnet.fi
Listed Location Countries Finland
Removed Location Countries  
 
Administrative Information
NCT Number NCT03074084
Other Study ID Numbers R16006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Tampere University Hospital
Study Sponsor Tampere University Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Satu-Liisa K Pauniaho, MD, PhD Tampere University Hospital, Finland
PRS Account Tampere University Hospital
Verification Date March 2020