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

Primary Purpose

Appendicitis

Status
Unknown status
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Microwave radiometry
Sponsored by
Hippocration General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Appendicitis focused on measuring Appendicitis, Diagnosis, Microwave radiometry, Ultrasonography

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

-

Sites / Locations

  • Hippocration General hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Microwave radiometry

Arm Description

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.

Outcomes

Primary Outcome Measures

Appendix Temperature
Microwave radiometry will assess the temperature of the appendix for the patients diagnosed with appendicitis before they undergo surgical removal of the appendix.

Secondary Outcome Measures

Full Information

First Posted
April 2, 2014
Last Updated
February 11, 2017
Sponsor
Hippocration General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02108340
Brief Title
Comparative Study of Microwave Radiometry and Ultrasonography for the Diagnosis of Acute Appendicitis
Official Title
Comparative Study of Microwave Radiometry and Ultrasonography for the Diagnosis of Acute Appendicitis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 2013 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
August 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hippocration General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis
Keywords
Appendicitis, Diagnosis, Microwave radiometry, Ultrasonography

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Microwave radiometry
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Microwave radiometry
Intervention Description
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.
Primary Outcome Measure Information:
Title
Appendix Temperature
Description
Microwave radiometry will assess the temperature of the appendix for the patients diagnosed with appendicitis before they undergo surgical removal of the appendix.
Time Frame
Baseline

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of appendicitis Surgical removal of appendix Pathological confirmation of appendicitis Exclusion Criteria: -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Konstantinos G. Toutouzas, MD, PhD
Phone
00306970801370
Email
tousur@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Konstantinos G. Toutouzas, MD, PhD
Organizational Affiliation
Hippocration General Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Evagelia Stamouli, MD
Organizational Affiliation
Hippocration General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hippocration General hospital
City
Athens
State/Province
Attiki
ZIP/Postal Code
115 27
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Konstantinos G. Toutouzas, MD, PhD
First Name & Middle Initial & Last Name & Degree
Evagelia Stamouli, MD
First Name & Middle Initial & Last Name & Degree
Konstantinos Stasinos, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
22538335
Citation
Toutouzas K, Grassos C, Drakopoulou M, Synetos A, Tsiamis E, Aggeli C, Stathogiannis K, Klettas D, Kavantzas N, Agrogiannis G, Patsouris E, Klonaris C, Liasis N, Tousoulis D, Siores E, Stefanadis C. First in vivo application of microwave radiometry in human carotids: a new noninvasive method for detection of local inflammatory activation. J Am Coll Cardiol. 2012 May 1;59(18):1645-53. doi: 10.1016/j.jacc.2012.01.033.
Results Reference
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PubMed Identifier
20736499
Citation
Arunachalam K, Maccarini PF, De Luca V, Bardati F, Snow BW, Stauffer PR. Modeling the detectability of vesicoureteral reflux using microwave radiometry. Phys Med Biol. 2010 Sep 21;55(18):5417-35. doi: 10.1088/0031-9155/55/18/010. Epub 2010 Aug 25.
Results Reference
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PubMed Identifier
21256490
Citation
Toutouzas K, Grassos H, Synetos A, Drakopoulou M, Tsiamis E, Moldovan C, Agrogiannis G, Patsouris E, Siores E, Stefanadis C. A new non-invasive method for detection of local inflammation in atherosclerotic plaques: experimental application of microwave radiometry. Atherosclerosis. 2011 Mar;215(1):82-9. doi: 10.1016/j.atherosclerosis.2010.12.019. Epub 2010 Dec 23. No abstract available.
Results Reference
background
PubMed Identifier
22273794
Citation
Hassan AM, El-Shenawee M. Review of electromagnetic techniques for breast cancer detection. IEEE Rev Biomed Eng. 2011;4:103-18. doi: 10.1109/RBME.2011.2169780.
Results Reference
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Comparative Study of Microwave Radiometry and Ultrasonography for the Diagnosis of Acute Appendicitis

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