Prospective Non-randomized Evaluation of Oncoplastic Surgery

Quality of Life Clinical Trial

— iTOP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01396993
• Other study ID #: iTOP
• Status: Active, not recruiting
• Phase: N/A
• First received: July 18, 2011
• Last updated: September 22, 2015
• Start date: July 2011
• Est. completion date: August 2016

Study information

• Verified date: September 2015
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: August 2016
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

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
• Breast Surgery
Breast conserving therapy without defect correction

Locations

Country	Name	City	State
Austria	Medical University Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	breast image scale	self esteem measured by the breast image scale will be assessed before and every 6 months after surgery as primary endpoint.	2 years	No
Secondary	quality of life	BREAST Q, non-validated questionnaires	2 years	No
Secondary	Morbidity	Necrosis, infection, reoperations and bleedings as well as heamtoma and seroma formation will be clinically assessed after surgery	6 months	Yes
Secondary	breast symmetry index	Using the breast analyzing tool software we will analyze breast symmetry before and every 6 months after surgery	2 years	No
Secondary	oncologic parameters	local, distent and overal survival 2 as well as 5 years after surgery will be assessed	2-5 years	Yes