Clinical trial NCT01396993: Prospective Non-randomized Evaluation of Oncoplastic Surgery
Official title: Prospective Trial Evaluating Cosmetic And Oncologic Outcome Of Immediate Techniques For Oncoplastic Surgery In Breast Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Image Scale Index for Self Esteem Evaluation
Breast Symmetry Index
Quality of Life
Morbidity
Oncological Outcome
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2011-07-19
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.


Eligibility criteria: 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

Primary outcomes:
measure: breast image scale
timeFrame: 2 years
Secondary outcomes:
measure: quality of life
timeFrame: 2 years
measure: Morbidity
timeFrame: 6 months
measure: breast symmetry index
timeFrame: 2 years
measure: oncologic parameters
timeFrame: 2-5 years
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University Vienna
Study officials:
References: