Abdominal PainNCT03074084
Acute Abdomen in Adults- a Prospective Study on Emergency Department Admissions
An observational study of Abdominal Pain, run by Tampere University Hospital at 1 site in Finland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Pain
- How many people
- 1,000 participants
- Where
- 1 siteFinland
- Study dates
- Jun 2016to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- All adult patients with abdominal pain.
Who cannot join
- Under the age of 18 years
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Tampere University Hospital
Tampere
Satu-Liisa K Pauniaho, MD, PhD, +358505386783, satu-liisa.pauniaho@pshp.fi
Mika T Ukkonen, MD, PhD, MEcon, +358443454523, mika.ukkonen@fimnet.fi
About this study
Official title: Acute Abdomen in Adults- a Prospective Study on Causes of Abdominal Pain Leading to Emergency Department Admission in Tampere University Hospital
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.
Read the 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.
- Conditions
- Abdominal Pain
- Keywords
- abdominal pain, adult, emergency department, electronic nose, celiac disease
- Medical subject headings
- Abdominal Pain, Emergencies, Celiac Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with specific diagnose
Population based analysis of incidence of diseases
Measured: One month
Secondary outcomes (4)
Number of patients misdiagnosed in emergency department and requiring readmission
Measured: One month
Number of participants with treatment related adverse events
Measured: One month
Diagnostic accuracy of polyamine molecule analysis
Measured: One month
Number of patients with undiagnosed coeliac disease
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2017
- Study startJun 2016
- Primary completionDec 2021 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal PainStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Satu-Liisa K Pauniaho, MD, PhD, Principal investigator, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03074084
- Sponsor's protocol ID
- R16006
- Status last verified
- Mar 2020
- First submitted
- 20 Oct 2016
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Abdomen in Adults- a Prospective Study on Causes of Abdominal Pain Leading to Emergency Department Admission in Tampere University Hospital
- ClinicalTrials.gov ID
- NCT03074084
- Acronym / sponsor ID
- R16006
- Conditions
- Abdominal Pain
- Keywords
- abdominal pain, adult, emergency department, electronic nose, celiac disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Dec 2021 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All adult patients with abdominal pain.
Key exclusion criteria (1 listed)
- Under the age of 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients with specific diagnose
Time frame: One month
Population based analysis of incidence of diseases
4 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Satu-Liisa K Pauniaho, MD, PhD principal investigator
Tampere University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Pain, run by Tampere University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mika T Ukkonen, MD, PhD, MEcon (+358443454523, mika.ukkonen@fimnet.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with specific diagnose (time frame: One month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2020.