Prospective Non-randomized Evaluation of Oncoplastic Surgery (iTOP)

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

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.

Study Overview

• Status: Unknown
• Conditions: Quality of Life; Morbidity; Breast Image Scale Index for Self Esteem Evaluation; Breast Symmetry Index; Oncological Outcome
• Intervention / Treatment: Procedure: Breast Surgery; Procedure: Breast Surgery

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Medical University Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients with a BIRADS IV, V or VI breast lesion are preoperatively asked to take part in this study if more than 10% of breast tissue will be excised or mastectomy and immediate reconstruction is planned. Patients with planned mastectomy without immediate reconstruction are not included. Patients scheduled for breast conservation can decide whether they undergo regular breast conservation (BCT) or BCT using immediate techniques of oncoplastic surgery (iTOP). A contralateral correction may be performed in both groups at any time of the trial. The use of a contralateral correction of patients without an immediate oncoplastic procedure does not initiate a change into the other group (intention to treat analyses).

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	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
BCT; patients undergoing conservative breast surgery	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): July 1, 2015
• Study Completion (Anticipated): August 1, 2016

Study Registration Dates

• First Submitted: July 18, 2011
• First Submitted That Met QC Criteria: July 18, 2011
• First Posted (Estimate): July 19, 2011

Study Record Updates

• Last Update Posted (Estimate): September 23, 2015
• Last Update Submitted That Met QC Criteria: September 22, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: iTOP