Impact of Unenhanced Computed Tomography (CT) in Elderly Patients Admitted to the Emergency Department With Acute Abdominal Pain

Abdominal Pain Clinical Trial

Official title:

Accuracy of Unenhanced CT in Elderly Patients Admitted to the Emergency Department With Acute Abdominal Symptoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02355483
• Other study ID #: 8741
• Secondary ID: 2011-A00868-33
• Status: Completed
• Phase: N/A
• First received: January 30, 2015
• Last updated: January 30, 2015
• Start date: May 2012
• Est. completion date: August 2014

Study information

• Verified date: January 2015
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Description:

A systematic unenhanced abdominal CT is performed in elderly patients admitted to the emergency patients with acute abdominal symptoms. Accuracy of unenhanced CT is assessed by comparing diagnosis and therapeutic management recorded before and after unenhanced CT versus gold standard diagnosis and management. Gold standard diagnosis and management are established at 3 month follow up, based on patient's medical records and a systematic telephone interview.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 423
• Est. completion date: August 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 75 Years and older

Eligibility

Inclusion Criteria:

• Elderly patients admitted to the emergency department (aged 75 year old and older)

• acute abdominal pain

• informed consent

Exclusion criteria:

• traumatic pain

• symptom duration of more than a week

• unability for the patient to give informed consent

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Abdominal Pain

Intervention

Device:
• Unenhanced abdominal Computed Tomography
Systematic Unenhanced abdominal Computed tomography

Locations

Country	Name	City	State
France	Medical Imaging department	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Therapeutic management accuracy	Therapeutic management made by the attending ED physician both before and after unenhanced abdominal CT is compared to reference management established at 3 month follow-up. Therapeutic management is assessed by patient orientation following ED admission, need for hospitalization and surgical or medical treatment.	3 months	No