Prospective Non-randomized Evaluation of Oncoplastic Surgery (iTOP)

Medical University of Vienna

Status: Unknown

Conditions: Breast Image Scale Index for Self Esteem Evaluation; Quality of Life; Oncological Outcome; Breast Symmetry Index; Morbidity

Treatments: Procedure: Breast Surgery

Study type: Observational

Funder types: Other

Identifiers

NCT01396993

iTOP

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: 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

Trial design

150 participants in 2 patient groups

iTOP

Description:

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

Treatment:

Procedure: Breast Surgery

Procedure: Breast Surgery

BCT

Description:

patients undergoing conservative breast surgery

Treatment:

Procedure: Breast Surgery

Procedure: Breast Surgery