Department of Plastic Surgery, University of Gothenburg, The Sahlgrenska Academy, Institute of Clinical Sciences, Sahlgrenska University Hospital, Gothenburg, Sweden.
Department of Plastic Surgery, University of Gothenburg, The Sahlgrenska Academy, Institute of Clinical Sciences, Sahlgrenska University Hospital, Gothenburg, Sweden.
Eur J Surg Oncol. 2020 Dec;46(12):2208-2217. doi: 10.1016/j.ejso.2020.07.010. Epub 2020 Jul 26.
There is little high-quality scientific evidence identifying the best and safest methods for delayed breast reconstruction, with most previous studies retrospective in nature. The primary aim was to compare early complication rates for two different breast-reconstructive methods in radiated and non-radiated patients, using a validated scale. The secondary aim was to identify predictors for complications.
This study represents a clinical, randomized, prospective trial (ClinicalTrials.Gov identifier: NCT03963427), where the patients were divided into two study arms: non-radiated and radiated. In the non-radiated arm, patients were randomized to a one-stage lateral thoracodorsal flap with an implant or two-stage expander reconstruction. In the radiated arm, patients were randomized to a latissimus dorsi reconstruction combined with an implant or deep inferior epigastric artery perforator (DIEP) reconstruction. All adverse events were classified according to Clavien-Dindo and summarization of overall morbidity was performed by calculating the Comprehensive Complication Index score. The study was conducted from 2008 to 2020.
The complication frequencies were similar for the two surgical methods within each arm. In the non-radiated arm, risk factors for any complication were any comorbidities, and in the radiated arm, factors were a high body mass index and a contralateral operation.
The usage of the Clavien-Dindo scale in reconstructive surgery is feasible, but further validation is needed. In non-radiated patients, the frequencies of short-term complications were similar for lateral thoracodorsal flap and expander reconstruction, whereas in radiated patients, they were similar for DIEP and latissimus dorsi. The complication profile of the methods varied.
很少有高质量的科学证据能确定延迟性乳房重建的最佳和最安全方法，大多数先前的研究都是回顾性的。主要目的是使用验证后的量表比较两种不同的乳房重建方法在放射治疗和非放射治疗患者中的早期并发症发生率。次要目的是确定并发症的预测因素。
本研究代表了一项临床、随机、前瞻性试验（ClinicalTrials.Gov 标识符：NCT03963427），患者被分为两个研究组：非放射治疗组和放射治疗组。在非放射治疗组中，患者被随机分为一期外侧胸背皮瓣联合植入物或二期扩张器重建。在放射治疗组中，患者被随机分为背阔肌重建联合植入物或腹壁下动脉穿支皮瓣（DIEP）重建。所有不良事件均按照 Clavien-Dindo 分类，并通过计算综合并发症指数评分来总结总体发病率。该研究于 2008 年至 2020 年进行。
在每个组内，两种手术方法的并发症发生率相似。在非放射治疗组中，任何并发症的危险因素是任何合并症，在放射治疗组中，危险因素是高体重指数和对侧手术。
Clavien-Dindo 量表在重建手术中的应用是可行的，但需要进一步验证。在非放射治疗患者中，外侧胸背皮瓣和扩张器重建的短期并发症发生率相似，而在放射治疗患者中，DIEP 和背阔肌的并发症发生率相似。方法的并发症谱不同。
