Evaluation of a New Technique to Fill the Defect Generated After Conservative Surgery in Breast Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of a New Technique to Fill the Defect Generated After Conservative Surgery in Breast Cancer: Randomized Clinical Trial

Conditions
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Breast Conserving Surgery

Intervention / Treatment
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* Device: Silicone prosthesis
* Procedure: Usual practice


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group whith silicone prothesis Group whith standard surgical procedure
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group intervention: Silicone prothesis<br>Breast cancer conservative surgery will be performed by removing the tumor according to the usual technique and then the defect generated will be filled with a silicone prosthesis of the same size. Said prosthesis will be covered with fat and subcutaneous cellular tissue and then the skin will be closed. | Device: Silicone prosthesis<br>* Silicone prosthesis<br>|
| Active Comparator: Group control: Usual surgical technique<br>Breast cancer conservative surgery will be performed according to the usual surgical technique, that is, removing the tumor and covering the defect by mobilizing the breast tissue and then closing the skin. | Procedure: Usual practice<br>* Usual surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aesthetic result | 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) | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical complications | Incidence of surgical complications. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Neoplasms, Breast Conserving Surgery