NCT02355483

Brief Summary

The purpose of this study is to determine whether non-contrast abdominal computed tomography (CT) impacts management (diagnosis, need for surgery and treatment) in elderly patients admitted to the emergency department with abdominal pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
423

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 4, 2015

Completed
Last Updated

February 4, 2015

Status Verified

January 1, 2015

Enrollment Period

2 years

First QC Date

January 30, 2015

Last Update Submit

January 30, 2015

Conditions

Abdominal Pain

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy

    Emergency Department (ED) diagnosis made prospectively by the attending ED physician both before and after unenhanced abdominal CT is compared to the reference diagnosis established at 3 month follow-up. Both ED diagnosis and reference diagnosis are recorded using a standardized diagnosis list.

    3 months

Secondary Outcomes (1)

  • Therapeutic management accuracy

    3 months

Interventions

Unenhanced abdominal Computed TomographyDEVICE

Systematic Unenhanced abdominal Computed tomography

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Elderly patients admitted to the emergency department (aged 75 year old and older)
  • acute abdominal pain
  • informed consent

You may not qualify if:

  • traumatic pain
  • symptom duration of more than a week
  • unability for the patient to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Imaging department

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Abdominal Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Study Officials

  • Ingrid MILLET, MD

    Montpellier University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2015

First Posted

February 4, 2015

Study Start

May 1, 2012

Primary Completion

May 1, 2014

Study Completion

August 1, 2014

Last Updated

February 4, 2015

Record last verified: 2015-01

Locations

FR(1)