Evaluation of a New Technique to Fill the Defect Generated After Conservative Surgery in Breast Cancer
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
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.
Study Design
Conditions
Breast Conserving Surgery
Intervention
Silicone prosthesis, Usual practice
Location
Hospital de la Santa Creu i Sant Pau
Barcelona
Spain
08041
Status
Recruiting
Source
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT04092842
- ClinicalTrials.gov processed this data on September 20, 2019
Published on BioPortfolio: 2019-09-23T04:51:44-0400
Clinical Trials
Breast-Conserving Surgery Techniques in Treating Women With Breast Cancer
RATIONALE: Breast-conserving surgery is a less invasive type of surgery for breast cancer and may have fewer side effects and improve recovery. PURPOSE: This phase II trial is studying di...
The purpose of this study is to describe the relations between closed suction drains placement in breast reconstructions procedures with silicone prothesis to the development of local woun...
This research study is a way of gaining new knowledge about whether patients can omit radiation treatment after undergoing a lumpectomy, also known as "breast conserving surgery". In this ...
Partial Breast Irradiation for Low-risk Ductal Carcinoma In Situ After Breast-conserving Surgery
This study is designed to evaluate the feasibility and safety of partial breast irradiation for low risk DCIS after breast-conserving surgery.
RATIONALE: Breast-conserving treatments such as radiation therapy or limited surgery are less invasive than mastectomy and may improve the quality of life. It is not yet known if breast-co...
PubMed Articles
Breast-Conserving Surgery in Patients With Mammary Paget's Disease.
We aimed to analyze the association between Paget's disease (PD) and breast cancer (BC) subtypes and compare the effect of breast-conserving surgery (BCS) as a local treatment with mastectomy for PD.
Breast-conserving surgery (BCS) with radiation therapy is the procedure of choice for early-stage breast cancer. Survival and locoregional recurrence is non-inferior to mastectomy, with superior cosme...
Re-excision surgery is undertaken to obtain clear margins after breast-conserving surgery (BCS) for localized breast cancer. This study examines patient and tumor characteristics related to re-excisio...
Aspergillus fumigatus Spores Are Not Able to Penetrate Silicone Breast Implant Shells.
Bacterial contamination is hypothesized to be one reason for the development of capsular contracture after alloplastic breast reconstruction using silicone breast implants. The role of fungal coloniza...
Breast-conserving surgery without radiation in elderly women with early breast cancer.
Irradiation after breast-conserving surgery (BCS) decreases the incidence of ipsilateral breast tumor recurrence (IBTR) and breast cancer-related death. However, daily radiation treatments are burdens...
Medical and Biotech [MESH] Definitions
Breast Implants
Implants used to reconstruct and/or cosmetically enhance the female breast. They have an outer shell or envelope of silicone elastomer and are filled with either saline or silicone gel. The outer shell may be either smooth or textured.
Silicone Gels
Synthetic organosiloxane gels that are formed from synthetic polymers of silicone oxide with organic sidechains (polydimethylsiloxane) by lengthening the polymer chains. Unlike silicone elastomers, they are not treated with amorphous silica. They are used as fillers in breast implants.
Maxillofacial Prosthesis
A prosthetic appliance for the replacement of areas of the maxilla, mandible, and face, missing as a result of deformity, disease, injury, or surgery. When the prosthesis replaces portions of the mandible only, it is referred to as MANDIBULAR PROSTHESIS.
Breast Implantation
Surgical insertion of an inert sac filled with silicone or other material to augment the female form cosmetically.
Stapes Surgery
Surgery performed in which part of the STAPES, a bone in the middle ear, is removed and a prosthesis is placed to help transmit sound between the middle ear and inner ear.
More From BioPortfolio on "Evaluation of a New Technique to Fill the Defect Generated After Conservative Surgery in Breast Cancer"
Quick Links
Advanced Search |
Login |
Subscribe |
RSS 
BioPortfolio Twitter Channels (200+ Accounts)
LinkedIn