Breast Unit, Department of Surgery, University Hospital Complex A Coruña, A Coruña, Spain.
PLoS One. 2022 Jul 14;17(7):e0269426. doi: 10.1371/journal.pone.0269426. eCollection 2022.
Mastectomy currently constitutes a necessary surgical procedure in the oncologic setting and in the context of high risk. Prepectoral breast reconstruction (PBR) has been proposed as a surgical alternative to retropectoral techniques by providing less postoperative morbidity and a better cosmetic result. However, there is a lack of prospective studies that have evaluated its safety and patient-reported satisfaction.
We conducted a prospective cohort study to assess the safety, quality of life and cosmetic sequelae of PBR in women with breast cancer and high risk. The study's main objective is to assess the safety of PBR 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 MRI 12 to 18 months after the surgery, and the quality-of-life assessment will be performed using the Breast-Q 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.
The PreQ-20 study will analyze the impact of PBR on 3 separate measures: safety, quality of life and cosmetic sequelae. Unlike other studies that analyzed these three measures jointly for women with breast cancer and high risk, this study will individualize the results for these 2 patient groups. This differentiation is necessary from the methodological point of view, given that the 2 patient groups have separate clinical and emotional implications. The assessment of these groups will focus on the following aspects: postoperative complications, local relapses, evaluation of residual glandular tissue and incidence rate of primary tumors in the same, the cosmetic sequelae and the satisfaction and the quality-of-life assessment by the patients.
ClinicalTrials.gov: NCT04642508.
在肿瘤学背景下和高危情况下，乳房切除术目前是一种必要的手术程序。胸肌前置乳房重建术（PBR）已被提议作为后胸肌技术的替代方法，其具有较低的术后发病率和更好的美容效果。然而，缺乏评估其安全性和患者报告满意度的前瞻性研究。
我们进行了一项前瞻性队列研究，以评估患有乳腺癌和高危的女性的 PBR 的安全性、生活质量和美容后遗症。该研究的主要目的是评估 PBR 在术后并发症和重建可行性（植入物丢失）方面的安全性。次要目标是评估肿瘤学安全性（局部复发、残留腺组织）并确定与生活质量和美容后遗症相关的因素。残留组织的评估将在手术后 12 至 18 个月进行 MRI 检查，生活质量评估将使用乳房质量问卷（Breast-Q）进行。手术 12-18 个月后进行初始患者评估，5 年后进行第二次评估。估计样本量为 81 例患者。
PreQ-20 研究将分析 PBR 对 3 个独立指标的影响：安全性、生活质量和美容后遗症。与其他分析乳腺癌和高危女性这三个指标的研究不同，这项研究将为这两个患者群体分别分析结果。从方法论的角度来看，这种区别是必要的，因为这两个患者群体具有不同的临床和情感影响。对这两个群体的评估将集中在以下方面：术后并发症、局部复发、残留腺组织评估和同侧原发性肿瘤的发生率、美容后遗症以及患者的满意度和生活质量评估。
ClinicalTrials.gov：NCT04642508。
