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

Primary Purpose

Abdominal Pain

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Unenhanced abdominal Computed Tomography
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Abdominal Pain

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical Imaging department

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 30, 2015
Last Updated
January 30, 2015
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT02355483
Brief Title
Impact of Unenhanced Computed Tomography (CT) in Elderly Patients Admitted to the Emergency Department With Acute Abdominal Pain
Official Title
Accuracy of Unenhanced CT in Elderly Patients Admitted to the Emergency Department With Acute Abdominal Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Pain

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
423 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Unenhanced abdominal Computed Tomography
Intervention Description
Systematic Unenhanced abdominal Computed tomography
Primary Outcome Measure Information:
Title
Diagnostic accuracy
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Therapeutic management accuracy
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ingrid MILLET, MD
Organizational Affiliation
Montpellier University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Imaging department
City
Montpellier
ZIP/Postal Code
34295
Country
France

12. IPD Sharing Statement

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

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