Breast Conserving Surgery
Conditions
Keywords
Breast Neoplasms, Breast Conserving Surgery
Brief summary
The placement of a small silicone prosthesis in the partial defects generated by conservative breast cancer surgery improves the aesthetic result, compared to the usual surgical technique, in a safe and reproducible way and compatible with adjuvant treatments. It could also potentially improve the quality of life of patients
Detailed description
Conservative surgery in breast cancer is performed more than 50% of cases, however, aesthetic results are suboptimal, because reconstructive techniques are performed in less than 5% of them. Objective: To demonstrate that the placement of a silicone prosthesis in partial defects generated by breast cancer conservative surgery improves the aesthetic result, compared to the usual surgical technique, safely, reproducibly and compatible with adjuvant treatments. Methodology: Prospective randomized clinical trial, controlled with blind evaluator. Inclusion criteria: Women with breast cancer candidates for conservative surgery. Intervention: In the cases the study technique will be carried out consisting in the filling of the defect with a silicone prosthesis of size adjusted to it (2-4cm). Controls: usual surgical procedure. Main result variable: aesthetic results (visual analog scale) according to the patient, surgeon and blind external evaluator. Secondary variables: surgical complications, local complications derived from adjuvant treatments, rate of local recurrence, rate of reintervention due to affected margins, behavior in mammographic follow-up, professional satisfaction and impact on quality of life.
Interventions
DEVICESilicone prosthesis
Silicone prosthesis
PROCEDUREUsual practice
Usual surgery
Sponsors
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Group whith silicone prothesis Group whith standard surgical procedure
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Women, over 18 years old, with breast cancer who attend breast pathology consultations at the Sant Pau Hospital in which conservative surgery is indicated.
Exclusion criteria
* Multicentric tumors * Tumors larger than 5cm * Locally advanced tumors (T4): Deep plane involvement or skin involvement * Patients in stages IV (distance dissemination) * Patients who need mastectomy * Patients with disabilities or who do not understand the terms of the study or do not agree to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aesthetic result | 4 weeks | Aesthetic result of the new technique by applying a visual analog scale for measuring patient satisfaction. Scale ranges: minimum score: 0 (no satisfaction - worse outcome), maximum score: 10 (total satisfaction - better outcome) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical complications | 4 weeks | Incidence of surgical complications. |
Countries
Spain
Outcome results
None listed