NCT03074084

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2016

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 8, 2017

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 6, 2020

Status Verified

March 1, 2020

Enrollment Period

5.5 years

First QC Date

October 20, 2016

Last Update Submit

March 5, 2020

Conditions

Abdominal Pain

Keywords

abdominal painadultemergency departmentelectronic noseceliac disease

Outcome Measures

Primary Outcomes (1)

  • Number of patients with specific diagnose

    Population based analysis of incidence of diseases

    One month

Secondary Outcomes (4)

  • Number of patients misdiagnosed in emergency department and requiring readmission

    One month

  • Number of participants with treatment related adverse events

    One month

  • Diagnostic accuracy of polyamine molecule analysis

    One month

  • Number of patients with undiagnosed coeliac disease

    One month

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • All adult patients with abdominal pain.

You may not qualify if:

  • Under the age of 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampere University Hospital

Tampere, Finland

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

urine sample, blood sample

MeSH Terms

Conditions

Abdominal PainEmergenciesCeliac Disease

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveDisease AttributesPathologic ProcessesMalabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Satu-Liisa K Pauniaho, MD, PhD

    Tampere University Hospital, Finland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mika T Ukkonen, MD, PhD, MEcon

CONTACT

+358443454523mika.ukkonen@fimnet.fi

Leena M Saaristo, MD

CONTACT

+358405030201leena.saaristo@fimnet.fi

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2016

First Posted

March 8, 2017

Study Start

June 1, 2016

Primary Completion

December 1, 2021

Study Completion

December 31, 2025

Last Updated

March 6, 2020

Record last verified: 2020-03

Locations

FI(1)