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Prospective Non-randomized Evaluation of Oncoplastic Surgery

NCT01396993 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2015-09-23

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2015-07-31
Completion
2016-08-31

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01396993 on ClinicalTrials.gov