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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prepectoral Reconstruction | Other | Women with breast cancer or with high risk for breast cancer in whom a sparing mastectomy and prepectoral reconstruction was performed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prepectoral reconstruction | Procedure | Immediate prepectoral breast reconstruction in women requiring a mastectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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 | 3 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 year after surgery |
| Incidence of breast cancer relapse (oncological safety) |
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Inclusion Criteria:
The study population will include 2 patient groups:
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.
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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benigno Acea Nebril, PhD. | University Hospital A Coruña | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Abente y Lago | A Coruña | Galicia | 15006 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35834508 | Derived | Acea-Nebril B, Garcia-Novoa A, Garcia Jimenez L. The PreQ-20 TRIAL: A prospective cohort study of the oncologic safety, quality of life and cosmetic outcomes of patients undergoing prepectoral breast reconstruction. PLoS One. 2022 Jul 14;17(7):e0269426. doi: 10.1371/journal.pone.0269426. eCollection 2022. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 21, 2024 | |
| Reset | Jul 18, 2024 | |
| Release | Jul 20, 2024 | |
| Reset | Oct 10, 2024 | |
| Release | Dec 8, 2024 | |
| Reset | Jan 23, 2025 | |
| Release | Jan 24, 2025 | |
| Reset | Feb 14, 2025 | |
| Release | Feb 16, 2025 | |
| Reset | Mar 7, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 21, 2024 | Jul 18, 2024 | |||
| Jul 20, 2024 |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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To evaluate the safety of sparing mastectomy through the identification relapses in the same breast during the follow up |
| 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 | 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) | 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. | yearly, up to 5 years. From surgery date until the date of first documented cosmetis sequelae |
| Oct 10, 2024 |
| Dec 8, 2024 | Jan 23, 2025 |
| Jan 24, 2025 | Feb 14, 2025 |
| Feb 16, 2025 | Mar 7, 2025 |
| D017437 |
| Skin and Connective Tissue Diseases |