Prospective Non-randomized Evaluation of Oncoplastic Surgery

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

• Registration Number: NCT01396993
• Lead Sponsor: Medical University of Vienna

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-18
• Study First Submitted QC: 2011-07-18
• Study First Posted: 2011-07-19
• Primary Completion: 2015-07
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-22
• Last Update Posted: 2015-09-23
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 150

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

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Exclusion Criteria

• Inflammatory breast cancer
• Progression after neoadjuvant therapy
• Pregnant women
• Patients unable to perform surgery under general anaesthesia
• Bilateral breast lesions

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BCT	Breast Surgery	patients undergoing conservative breast surgery
iTOP	Breast Surgery	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

Primary Outcome Measures

Name	Time	Method
breast image scale	2 years	self esteem measured by the breast image scale will be assessed before and every 6 months after surgery as primary endpoint.

Secondary Outcome Measures

Name	Time	Method
Morbidity	6 months	Necrosis, infection, reoperations and bleedings as well as heamtoma and seroma formation will be clinically assessed after surgery
breast symmetry index	2 years	Using the breast analyzing tool software we will analyze breast symmetry before and every 6 months after surgery
oncologic parameters	2-5 years	local, distent and overal survival 2 as well as 5 years after surgery will be assessed
quality of life	2 years	BREAST Q, non-validated questionnaires

Trial Locations

Locations (1)

Medical University Vienna; 🇦🇹 Vienna, Austria