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The Use of a High-frequency Ultrasonic Knife in Breast Cancer Surgery (UKBC)

This study has been completed.
Sponsor:
Information provided by:
University of Trieste
ClinicalTrials.gov Identifier:
NCT00996632
First received: April 24, 2009
Last updated: November 4, 2009
Last verified: November 2009
Results First Received: April 24, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Procedure: ultrasonic knife (Ultracision®, Ethicon Endo Surgery)
Procedure: conventional diarthermy knife

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients affected by Breast Cancer

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Ultrasonic Patients were operated using an ultrasonic knife (Ultracision Ethicon TM)
Conventional Patients were operated by a conventional diatherm knife

Participant Flow:   Overall Study
    Ultrasonic   Conventional
STARTED   38   56 
COMPLETED   38   56 
NOT COMPLETED   0   0 
Physician Decision                0                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Ultrasonic Patients were operated using an ultrasonic knife (Ultracision Ethicon TM)
Conventional Patients were operated by a conventional diatherm knife
Total Total of all reporting groups

Baseline Measures
   Ultrasonic   Conventional   Total 
Overall Participants Analyzed 
[Units: Participants]
 38   56   94 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   19   26   45 
>=65 years   19   30   49 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.6  (12.3)   65.0  (12.5)   64.7  (12.4) 
Gender 
[Units: Participants]
     
Female   37   56   93 
Male   1   0   1 
Region of Enrollment 
[Units: Participants]
     
Italy   38   56   94 


  Outcome Measures
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1.  Primary:   Drainage Volume   [ Time Frame: discharge day ]

2.  Secondary:   Time of Discharge   [ Time Frame: days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Prof. Nicolò de Manzini
Organization: University of Trieste
phone: +390403994152
e-mail: nicolo.demanzini@aots.sanita.fvg.it



Responsible Party: Pr Nicolò de Manzini, University of Trieste
ClinicalTrials.gov Identifier: NCT00996632     History of Changes
Other Study ID Numbers: MGiuricin
Study First Received: April 24, 2009
Results First Received: April 24, 2009
Last Updated: November 4, 2009
Health Authority: Italy: Ethics Committee