Comparative Study of Microwave Radiometry and Ultrasonography for the Diagnosis of Acute Appendicitis

February 11, 2017 updated by: Konstantinos Toutouzas, Hippocration General Hospital
This study will evaluate the use of microwave radiometry in a population of patients diagnosed with acute appendicitis and treated with appendectomy. The main purpose of the study is to report the results of microwave radiometry as a diagnostic tool in acute appendicitis and compare those results with the commonly used ultrasonography.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients diagnosed with acute appendicitis from the emergency department of Hippocration General Hospital and treated with appendectomy will be evaluated with microwave radiometry for changes in the temperature of the appendix before its removal.

Subsequently, the results of microwave radiometry for the patients confirmed by the histopathology report to have acute inflammation of the appendix, will be compared with those of the ultrasonography used for the diagnosis of acute appendicitis.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Konstantinos G. Toutouzas, MD, PhD
  • Phone Number: 00306970801370
  • Email: tousur@hotmail.com

Study Locations

  • Greece
    • Attiki
      • Athens, Attiki, Greece, 115 27
        • Recruiting
        • Hippocration General Hospital
        • Principal Investigator:
          • Konstantinos G. Toutouzas, MD, PhD
        • Principal Investigator:
          • Evagelia Stamouli, MD
        • Sub-Investigator:
          • Konstantinos Stasinos, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of appendicitis
  • Surgical removal of appendix
  • Pathological confirmation of appendicitis

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Microwave radiometry
Patients diagnosed with acute appendicitis will undergo a measurement of the temperature of the appendix with the use of microwave radiometry in a room temperature of 20 -24 degrees celsius.
Procedure: Microwave radiometry
Microwave radiometry of the right lower quadrant in a room temperature of 20-24 degrees celsius, in order to record changes in the temperature of the inflamed appendix.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Appendix Temperature
Time Frame: Baseline
Microwave radiometry will assess the temperature of the appendix for the patients diagnosed with appendicitis before they undergo surgical removal of the appendix.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hippocration General Hospital

Investigators

  • Study Chair: Konstantinos G. Toutouzas, MD, PhD, Hippocration General Hospital
  • Principal Investigator: Evagelia Stamouli, MD, Hippocration General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

April 2, 2014

First Submitted That Met QC Criteria

April 8, 2014

First Posted (Estimate)

April 9, 2014

Study Record Updates

Last Update Posted (Actual)

February 14, 2017

Last Update Submitted That Met QC Criteria

February 11, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ΕΣ 45/19-9-2013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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