Prospective Non-randomized Evaluation of Oncoplastic Surgery

NCT01396993 — Unknown, 150 participants, Medical University of Vienna

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Prospective Trial Evaluating Cosmetic And Oncologic Outcome Of Immediate Techniques For Oncoplastic Surgery In Breast Cancer

Registry	NCT01396993, acronym iTOP
Status	Unknown
Study type	Observational
Enrollment	150 (Estimated)
Sponsor	Medical University of Vienna (Other)
Conditions	Breast Image Scale Index for Self Esteem Evaluation, Breast Symmetry Index, Quality of Life, Morbidity, Oncological Outcome
Interventions	Breast Surgery (Procedure)
Dates	start 2011-07-01, primary completion 2015-07-01, completion 2016-08-01 (estimated), first posted 2011-07-19, last updated 2015-09-23
Locations	1 site in Austria

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
iTOP		Procedure: Breast Surgery	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
BCT		Procedure: Breast Surgery	patients undergoing conservative breast surgery

Breast Surgery (Procedure): 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
Breast Surgery (Procedure): Breast conserving therapy without defect correction

+Outcome measures

Primary outcomes

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

Secondary outcomes

quality of life [2 years]: BREAST Q, non-validated questionnaires
Morbidity [6 months]: Necrosis, infection, reoperations and bleedings as well as heamtoma and seroma formation will be clinically assessed after surgery
breast symmetry index [2 years]: Using the breast analyzing tool software we will analyze breast symmetry before and every 6 months after surgery
oncologic parameters [2-5 years]: local, distent and overal survival 2 as well as 5 years after surgery will be assessed

+Eligibility

Sex: Female, ages: 18 Years to 65 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Medical University Vienna	Vienna	Austria