Prospective Non-randomized Evaluation of Oncoplastic Surgery

NCT01396993 | Unknown DMC

• 1 other identifier: iTOP
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• quality of life

  2 years

• Morbidity

  6 months

• breast symmetry index

  2 years

• oncologic parameters

  2-5 years

Study Arms (2)

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

BCT

patients undergoing conservative breast surgery

Procedure: Breast Surgery

Interventions

Breast Surgery PROCEDURE

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

iTOP

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Interventions

Mastectomy, Segmental

Intervention Hierarchy (Ancestors)

Mastectomy; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: July 18, 2011
• First Posted: July 19, 2011
• Study Start: July 1, 2011
• Primary Completion: July 1, 2015
• Study Completion: August 1, 2016
• Last Updated: September 23, 2015

Record last verified: 2015-09

Locations

AU (1)