The PreQ-20 TRIAL, a Prospective Cohort Study of Patients Undergoing Prepectoral Breast Reconstruction
The PreQ-20 TRIAL, a Prospective Cohort Study of Patients Undergoing Prepectoral Breast Reconstruction
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.
Inclusion Criteria:

 -  We will include all women operated on in the Breast Unit through skin sparing
 mastectomy/Nipple skin sparing mastectomy (unilateral or bilateral) and immediate
 reconstruction with prepectoral implantation.

 The study population will include 2 patient groups:

 1. Women with breast carcinoma. This group consists of patients with a histological
 diagnosis of in situ or infiltrating breast carcinoma, either primary or metachronic,
 which requires mastectomy as the surgical treatment.

 2. Women at high risk for breast cancer. This group consists of women evaluated at a
 high-risk consultation and whose reducing risk mastectomy has been approved by the
 tumor committee of the Breast Unit of University Hospital Complex of A Coruna. For
 this procedure, the patients should meet at least one of the following criteria:

 -  Hereditary breast and ovarian cancer syndrome, either by demonstrated genetic
 mutation or through their family history.

 -  Histological diagnosis of high-risk lesions (atypical hyperplasia, ductal
 carcinoma in situ, lobular carcinoma in situ) associated with family history.

 -  High-risk criteria (genetic, histological, family) during the breast cancer
 follow-up.

 Exclusion Criteria:

 -  Inability to undergo magnetic resonance imaging during the diagnosis and follow-up.

 -  Inability to fill out the BREAST-Q questionnaire.

 -  Unwillingness by the patient to participate in the study.

 -  Breast sarcomas.

 -  Benign breast tumors.

 -  Prepectoral breast reconstruction using expanders.

 -  Prepectoral reconstruction with mesh