Clinical trial · Observational
Prospective Non-randomized Evaluation of Oncoplastic Surgery
Prospective Trial Evaluating Cosmetic And Oncologic Outcome Of Immediate Techniques For Oncoplastic Surgery In Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Image Scale Index for Self Esteem Evaluation | — | UNRESOLVED | — |
| Breast Symmetry Index | — | UNRESOLVED | — |
| Morbidity | — | UNRESOLVED | — |
| Oncological Outcome | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breast Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- iTOP
- description
- 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
- interventionNames
- Procedure: Breast Surgery
- label
- BCT
- description
- patients undergoing conservative breast surgery
- interventionNames
- Procedure: Breast Surgery
Primary outcomes (1)
- measure
- breast image scale
- timeFrame
- 2 years
- description
- self esteem measured by the breast image scale will be assessed before and every 6 months after surgery as primary endpoint.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available