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Prospective Non-randomized Evaluation of Oncoplastic Surgery (iTOP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01396993
Recruitment Status : Unknown
Verified September 2015 by Florian Fitzal, Medical University of Vienna.
Recruitment status was:  Active, not recruiting
First Posted : July 19, 2011
Last Update Posted : September 23, 2015
Information provided by (Responsible Party):
Florian Fitzal, Medical University of Vienna

Brief Summary:
Breast conserving therapy (BCT) is the standard treatment for intraductal or invasive breast cancer patients. However cosmetic results, e.g. symmetry and nipple displacement, are sometimes poor reducing the quality of life. The use of immediate techniques for oncoplastic surgery (iTOP) seems to improve subjective cosmetic outcome. Oncologic safety of iTOP has been demonstrated by several authors using restrospective analyses. However, no prospective observational trial has been done to objectively evaluate cosmetic and oncologic outcome comparing BCT with iTOP. The aim of this study is to investigate this issue within a prospective non randomized observational trial at the Medical University Vienna.

Condition or disease Intervention/treatment
Breast Image Scale Index for Self Esteem Evaluation Breast Symmetry Index Quality of Life Morbidity Oncological Outcome Procedure: Breast Surgery

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Trial Evaluating Cosmetic And Oncologic Outcome Of Immediate Techniques For Oncoplastic Surgery In Breast Cancer
Study Start Date : July 2011
Actual Primary Completion Date : July 2015
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cosmetics

Group/Cohort Intervention/treatment
Patients undergoing immediate techniques for oncoplastic surgery (level I only parenchmyl rotation and breast undermining as well as level II using complex reduction plastics for nipple-areola-complex movings) and patients with mastectomy and immediate reconstruction
Procedure: Breast Surgery
breast conserving surgery AND immediate defect filling using local flaps (level I) or reduction plastics (level II) as well as mastectomy and immediate reconstruction using free flaps

patients undergoing conservative breast surgery
Procedure: Breast Surgery
Breast conserving therapy without defect correction

Primary Outcome Measures :
  1. breast image scale [ Time Frame: 2 years ]
    self esteem measured by the breast image scale will be assessed before and every 6 months after surgery as primary endpoint.

Secondary Outcome Measures :
  1. quality of life [ Time Frame: 2 years ]
    BREAST Q, non-validated questionnaires

  2. Morbidity [ Time Frame: 6 months ]
    Necrosis, infection, reoperations and bleedings as well as heamtoma and seroma formation will be clinically assessed after surgery

  3. breast symmetry index [ Time Frame: 2 years ]
    Using the breast analyzing tool software we will analyze breast symmetry before and every 6 months after surgery

  4. oncologic parameters [ Time Frame: 2-5 years ]
    local, distent and overal survival 2 as well as 5 years after surgery will be assessed

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with a BIRADS IV, V or VI breast lesion are preoperatively asked to take part in this study if more than 10% of breast tissue will be excised or mastectomy and immediate reconstruction is planned. Patients with planned mastectomy without immediate reconstruction are not included. Patients scheduled for breast conservation can decide whether they undergo regular breast conservation (BCT) or BCT using immediate techniques of oncoplastic surgery (iTOP). A contralateral correction may be performed in both groups at any time of the trial. The use of a contralateral correction of patients without an immediate oncoplastic procedure does not initiate a change into the other group (intention to treat analyses).

Inclusion Criteria:

  • Patients scheduled for unilateral breast conserving surgery due to cancer or a suspicious lesion, in whom >10%* of breast volume (measured by mammograms using a defined formular 37) has to be removed or breast cancer patients scheduled for mastectomy and immediate reconstruction (immediate or delayed contralateral correction is allowed)
  • BIRADS IV, V or VI are eligible
  • > 18 years of age
  • Psychological and physical capable of understanding and performing the trial
  • Signed written informed consent * If oncologic safety necessitates to resect more than half of one breast quadrant

Exclusion Criteria:

  • Inflammatory breast cancer
  • Progression after neoadjuvant therapy
  • Pregnant women
  • Patients unable to perform surgery under general anaesthesia
  • Bilateral breast lesions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01396993

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Medical University Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
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Responsible Party: Florian Fitzal, Professor of Surgery, Medical University of Vienna Identifier: NCT01396993    
Other Study ID Numbers: iTOP
First Posted: July 19, 2011    Key Record Dates
Last Update Posted: September 23, 2015
Last Verified: September 2015