NCT01396993

Prospective Non-randomized Evaluation of Oncoplastic Surgery

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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
PROCEDURE	Breast Surgery	Breast conserving therapy without defect correction

Timeline

• Start date: 2011-07-01
• Primary completion: 2015-07-01
• Completion: 2016-08-01
• First posted: 2011-07-19
• Last updated: 2015-09-23

Locations

1 site across 1 country: Austria