METHODS: This prospective non-randomised longitudinal cohort study (ClinicalTrials.gov identifier: NCT04842240) recruited patients undergoing immediate IBR at the Leeds Breast Unit (Sep 2019-Sep 2021). Data collection included patient characteristics and post-operative complications. Patient-Reported Outcome Measures were collected using the BREAST-Q questionnaire at baseline, 2 weeks, 3- and 12-months post-surgery.
RESULTS: Seventy-eight patients underwent IBR (46 patients pre-pectoral; 59% vs. 32 patients sub-pectoral; 41%). Similar complication rates were observed (15.2% pre-pectoral vs. 9.4% sub-pectoral; p = 0.44). Overall implant loss rate was 3.8% (6.5% pre-pectoral vs. 0% sub-pectoral; p = 0.13). Respective median Breast-Q scores for pre- and sub-pectoral IBR at 3 months were: breast satisfaction (58 vs. 48; p = 0.01), psychosocial well-being (60 vs. 57; p = 0.9), physical well-being (68 vs. 76; p = 0.53), and Animation Q scores (73 vs. 76; p = 0.45). Respective Breast-Q scores at 12 months were: breast satisfaction (58 vs. 53; p = 0.3), psychosocial well-being (59 vs. 60; p = 0.9), physical well-being (68 vs. 78; p = 0.18), and Animation Q scores (69 vs. 73; p = 0.4).
CONCLUSIONS: This study demonstrates equivalent clinical and patient-perceived outcomes between pre- and sub-pectoral IBR. The study findings can be utilised to aid informed decision making regarding either surgical option.
方法:这项前瞻性非随机纵向队列研究(ClinicalTrials.gov标识符:NCT04842240)招募了在利兹乳腺病房接受即时IBR的患者(2019年9月至2021年9月)。数据收集包括患者特征和术后并发症。在基线时使用BREAST-Q问卷收集患者报告的结果指标,2周,手术后3个月和12个月。
结果:78例患者接受了IBR(46例胸前;59%与胸肌下32例;41%)。观察到类似的并发症发生率(胸前15.2%vs.胸下9.4%;p=0.44)。总体植入物损失率为3.8%(胸前6.5%vs.0%胸下;p=0.13)。3个月时胸前和胸下IBR的各自中位乳房Q评分为:乳房满意度(58vs.48;p=0.01),社会心理健康(60vs.57;p=0.9),身体健康(68vs.76;p=0.53),和动画Q得分(73vs.76;p=0.45)。12个月时各自的乳房Q评分为:乳房满意度(58vs.53;p=0.3),社会心理健康(59vs.60;p=0.9),身体健康(68vs.78;p=0.18),和动画Q得分(69vs.73;p=0.4)。
结论:这项研究表明胸肌前和胸肌下IBR之间具有同等的临床和患者感知结果。研究结果可用于帮助有关任一手术选择的知情决策。