Breast Cancer Surgery
Conditions
Brief summary
Aim of the study is to investigate whether intra-surgical visualisation of malignoma reduces the resection rate in the case of R1 resection compared to the procedure without sonographic visualisation
Interventions
PROCEDURESonographically assisted breast surgery
Sonography
PROCEDUREConventional breast surgery
Conventional
Sponsors
University Hospital Tuebingen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 18 to 80 years * Female * Presurgical validated breast cancer * Unifocal to multifocal findings * Palpable and/o non-palpable findings * Neoadjuvant chemotherapy * Indication for breast conserving therapy * General operation ability and anesthesia ability * Consent to conventional breast conserving breast surgery with wire marking * Ability and will to follow the study conditions * Written declaration of consent after clarification
Exclusion criteria
* Sonographically not clearly delineate resection areal *
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| R0 resection rate | 3 years | proportion of surgical procedures for cancer in which the surgeon is able to completely remove all detectable tumor tissue with negative margins, indicating that no cancer cells remain in the surgical site |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight of primary resedate | 3 years | weight of the tumor tissue removed during surgery for cancer |
| Time for cut and sew | During surgery | duration of the surgical procedure from the initial incision to the completion of the closure of the incision site |
Countries
Germany
Outcome results
None listed