Germano Cristiana, Borriello Gerardo, Corazzelli Giuseppe, Abbate Vincenzo, Troise Stefania, Dell'Aversana Orabona Giovanni, Piombino Pasquale, Romano Antonio, Collà Ruvolo Claudia, Bonavolontà Paola
Maxillofacial Surgery Unit, Department of Neurosciences, Reproductive and Odontostomatological Sciences, University Federico II, Via Pansini 5, 80100, Naples, Republic of Italy.
Maxillofacial Surgery Unit, Department of Neurosciences, Reproductive and Odontostomatological Sciences, University Federico II, Via Pansini 5, 80100, Naples, Republic of Italy.
J Craniomaxillofac Surg. 2025 Aug;53(8):1129-1134. doi: 10.1016/j.jcms.2025.04.012. Epub 2025 May 4.
Salivary gland tumors have an incidence of 1 out of 100,000 people every year, representing 2-4 % of the head and neck tumors. Consensually, radical surgery is the choice in parotid tumors. Despite improvements in surgical and anatomy-preserving strategies, several complications exist in this surgery. Frey Syndrome is caused by an aberrant regeneration of parasympathetic nerve fibers of the auriculotemporal nerve after parotidectomy.
The purpose of the present study was to compare the surgical complication rate differences between patients undergone parotid gland tumor surgery with reconstruction performed by traditional methods (Group A), and by SurgiMend (Group B).
STUDY DESIGN, SETTING, AND SAMPLE: The clinical, surgical, and monitoring data of 300 consecutive patients operated at our Institution between 2017 and 2020 were assessed for statistical deductive purposes, shaping a cohort retrospective monocentric observational study.
PREDICTOR/EXPOSURE/INDEPENDENT VARIABLE/MAIN OUTCOME VARIABLE: The primary outcome variable was the rate of Frey Syndrome. Secondary outcomes were the other complication rates, including surgical site infections, dehiscence, hypertrophic scars, seromas, hematomas, and temporary and permanent facial nerve palsy.
To conduct the statistical study, we used descriptive and deductive analyses. We employed the Fisher's Exact test for both analyses. All statistical tests were "two-tailed", and significance was set to an α-error <0.05. Statistical differences between groups A and B on the categorical postoperative complications were investigated for deductive purposes.
This study demonstrated the SurgiMend reconstruction to be significantly associated with a lower rate of Frey Syndrome and hypertrophic scar for parotid gland tumor surgery.
and relevance: Our study, through sustained and homogeneous follow-up on patients with benign tumors of the parotid gland, associated with a large, representative, and homogeneous sample, allows us to assert the genuineness and reliability of the minor Frey Syndrome and hypertrophic scars rates for benign parotid tumor surgery.
涎腺肿瘤的发病率为每年10万人中有1例，占头颈部肿瘤的2%-4%。目前，根治性手术是腮腺肿瘤的首选治疗方式。尽管手术和保留解剖结构的策略有所改进，但该手术仍存在一些并发症。Frey综合征是腮腺切除术后耳颞神经副交感神经纤维异常再生所致。
本研究旨在比较采用传统方法重建（A组）和采用SurgiMend重建（B组）的腮腺肿瘤手术患者的手术并发症发生率差异。
研究设计、地点和样本：为进行统计推断，我们评估了2017年至2020年在我院连续接受手术的300例患者的临床、手术和监测数据，形成了一项队列回顾性单中心观察性研究。
预测因素/暴露因素/独立变量/主要结局变量：主要结局变量为Frey综合征的发生率。次要结局为其他并发症发生率，包括手术部位感染、裂开、肥厚性瘢痕、血清肿、血肿以及暂时性和永久性面神经麻痹。
为进行统计研究，我们采用了描述性和推断性分析。两种分析均采用Fisher精确检验。所有统计检验均为“双侧”，显著性设定为α错误<0.05。为进行推断，我们研究了A组和B组在术后分类并发症方面的统计学差异。
本研究表明，SurgiMend重建与腮腺肿瘤手术中较低的Frey综合征发生率和肥厚性瘢痕发生率显著相关。
我们的研究通过对腮腺良性肿瘤患者进行持续且统一的随访，并结合大量、具有代表性且同质化的样本，使我们能够确定腮腺良性肿瘤手术中较低的Frey综合征和肥厚性瘢痕发生率的真实性和可靠性。
