Prospective Non-randomized Evaluation of Oncoplastic Surgery

NCT ID: NCT01396993

Last Updated: 2015-09-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2016-08-31

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

iTOP

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

Breast Surgery

Intervention Type: 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

BCT

patients undergoing conservative breast surgery

Breast Surgery

Intervention Type: PROCEDURE

Breast conserving therapy without defect correction

Interventions

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

Intervention Type: PROCEDURE

Breast Surgery

Breast conserving therapy without defect correction

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Florian Fitzal

Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical University Vienna

Vienna, , Austria

Countries

Austria

Other Identifiers

iTOP

Identifier Type: -

Identifier Source: org_study_id