The investigators conducted a prospective cohort study to assess the safety, quality of life and cosmetic sequelae of prepectoral breast reconstruction in women with breast cancer and high risk. The study's main objective is to assess the safety of prepectoral breast reconstruction in terms of postsurgical complications and the feasibility of reconstruction (loss of implants). The secondary objectives are to evaluate oncologic safety (local relapses, residual glandular tissue) and to identify factors related to quality of life and cosmetic sequelae. The evaluation of residual tissue will be conducted by magnetic resonance imaging 12 to 18 months after the surgery, and the quality-of-life assessment will be performed using the BreastQ questionnaire. An initial patient evaluation will be conducted 12-18 months after the surgery, and a second evaluation will be performed at 5 years. The estimated sample size is 81 patients.
1. Mastectomy technique. The breast removal will be performed using a mastectomy adapted to the breast and optimizing the preservation of the breast's original elements (inframammary fold, skin envelope, fat transitions, nipple-areolar complex) according to each patient's anatomical and oncologic possibilities. 2. Reconstruction technique. The reconstruction will be performed by placing a silicone implant coated with polyurethane foam in the prepectoral position. 3. Preoperative assessment. All patients will be assessed by a surgeon of the breast unit. The decision for the mastectomy will be made in consensus with the multidisciplinary committee. Before the surgery, the patients will undergo a mammography and magnetic resonance imaging to confirm the tumor size and rule out multifocality/multicentricity, as well as an evaluation of the distribution of glandular tissue and transitions between the breast and chest wall. 4. Breast magnetic resonance imaging. This study will employ the first magnetic resonance imaging during the postoperative period (between 12 and 18 months) to assess the residual glandular tissue following the mastectomy. 5. BreastQ questionnaire. The BreastQ questionnaire is aimed at evaluating patient-reported satisfaction and quality of life through the use of breast reconstruction modules. The preoperative format, which is delivered to patients before the surgery, and the postoperative format, which is delivered to them 12-18 months after the surgery. Likewise, we will conduct a second postoperative assessment at 5 years of the surgery. d. Images. The evaluation of the cosmetic sequelae requires taking photographs of the patient's chest (from the suprasternal notch to navel). Photographs will be taken prior to the surgery (frontal, right and left lateral), then again at 12-18 months and finally at 5 years of the surgery.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
81
Immediate prepectoral breast reconstruction in women requiring a mastectomy
Hospital Abente y Lago
A Coruña, Galicia, Spain
Incidence of implant loss (Feasibility of recosntruction)
To evaluate the feasibility of prepectoral reconstruction in terms of implant loss the first year after surgery, also during oncological treatment (example: chemotherapy) (Unit of mesure: number of implant loss)
Time frame: First year after surgery
Incidence of surgical complications - reoperations (Safety)
To determine the global incidence of surgical complications, as well as the causes of complications in terms of: postoperative bleeding, skin necrosis, necrosis of the nipple areola complex, seroma and infection
Time frame: 3 months after surgery
Incidence of residual glandular tissue (Safety)
To evaluate the safety of sparing mastectomy through the identification of residual glandular tissue through a magnetic resonance one year after surgery
Time frame: 1 year after surgery
Incidence of breast cancer relapse (oncological safety)
To evaluate the safety of sparing mastectomy through the identification relapses in the same breast during the follow up
Time frame: yearly, up to 5 years. From surgery date until the date of documented realapse
Incidence of new breast cancer (safety of risk reducing mastectomy)
To evaluate the safety of risk reducing sparing mastectomy in high risk for breast cancer patientes through the identification of new breast cancer
Time frame: yearly, up to 5 years. From surgery date until the date of documented new breast cancer
Quality of life and satisfaction after a mastectomy with prepectoral reconstruction, using the BreastQ questionnaire
To assess satisfaction and quality of life after prepectoral reconstruction in women with breast cancer and those with high risk through breastQ questionnaire To identify factors related to satisfaction and quality of life after prepectoral reconstruction (e.g. marital status, psychological illnesse)
Time frame: 1 year and 5 year after surgery
Incidenca of cosmetic sequelae
To evaluate the cosmetic sequelae after prepectoral reconstruction in women with breast cancer and with high risk and Identify factors related to the cosmetic sequelae after prepectoral reconstruction. The investigators will employ the Clough classification, where type I sequelae identified the patients with breast asymmetry but no deformity, type II sequelae were defined by the presence of a deformity that could be corrected using a breast-conserving procedure, and type III sequelae identified those women whose breast showed a deformity or painful fibrosis that could only be solved through mastectomy. To determine the sequelae, the criteria of the breast surgeon will be used, documented through photos.
Time frame: yearly, up to 5 years. From surgery date until the date of first documented cosmetis sequelae
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