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临床试验/NCT07028437
NCT07028437已完成不适用

The Effect of Endoscopy-assisted Transoral Parotid Gland Tumor Excision Compared With Traditional Operation

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年1月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
VAS for aesthetic

研究概览

简要总结

Endoscopic-assisted surgery has become a popular technique in salivary gland surgery, particularly for parotid gland tumors. However, this technique has not yet been routinely applied to transoral parotid tumor resection. This retrospective study aimed to evaluate the outcomes of gland-preserving surgery in patients with benign parotid tumors undergoing endoscopic-assisted transoral resection.

The study included 30 patients with benign parotid tumors who underwent gland-preserving tumor resection: 15 underwent endoscopic-assisted transoral resection, while the other 15 underwent conventional tumor resection via the Blair S-shaped incision. Surgical feasibility, perioperative variables, postoperative appearance, and functional outcomes were assessed.

In both groups, all tumors were completely removed with negative margins. No significant differences were observed between the two groups in terms of intraoperative blood loss, postoperative drainage volume, average incision length, or facial nerve injury. However, the endoscopic-assisted transoral group demonstrated superior cosmetic outcomes. No tumor recurrence was observed during the 1-6 month follow-up period.

Therefore, endoscopic-assisted transoral parotid tumor resection is a safe approach for benign parotid tumors, offering both favorable functional and aesthetic results.

详细描述

The incidence of parotid gland tumors is approximately 1 in 100,000, accounting for 80% of all salivary gland tumors, with about 80% being benign. Parotid tumor resection is a well-established surgical technique. Traditionally, the Blair S-shaped incision has been used, but it leaves noticeable scars on the maxillofacial region, which can be a significant burden for both surgeons and patients. Additionally, postoperative complications such as great auricular nerve injury may occur.

In the mid-20th century, the standard surgical approaches for benign parotid tumors included total parotidectomy (with facial nerve sacrifice) or superficial parotidectomy (preserving the facial nerve), which significantly reduced tumor recurrence rates. However, due to the extensive surgical scope, these procedures were associated with a high incidence of complications such as facial nerve dysfunction, Frey's syndrome, salivary fistula, and facial scar deformities.

In recent years, with growing interest in minimally invasive surgery, studies have found that subtotal parotidectomy for benign parotid tumors not only reduces postoperative complications but also maintains comparable recurrence rates. To meet patients' aesthetic demands, more concealed hairline incisions have gained popularity, as the scars can be hidden behind the ear.

With advancements in minimally invasive techniques for parotid tumor surgery, surgeons have developed various approaches to minimize scarring and reduce complications, including retroauricular sulcus incisions, endoscopic-assisted techniques, and transoral/intraoral resections. Endoscopic-assisted techniques leave minimal or hidden scars postoperatively. The combination of intraoral incisions and endoscopy can further conceal surgical scars, reduce patient trauma, and improve satisfaction-without significant complications compared to traditional transcutaneous approaches.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with primary benign parotid tumors all underwent CT, MRI and ultrasound-guided FNAC examinations of parotid tumors before the operation. All the patients underwent glandular preservation surgery.

排除标准

  • The tumor diameter is greater than 6cm, has undergone radiotherapy, is a highly malignant tumor, a tumor invading the skin, and a recurrent tumor.

结局指标

主要结局

VAS for aesthetic

时间窗: 1、3、6 months after surgery

The assessment of postoperative aesthetics includes the Visual Analogue Scale (VAS); 0-10. 0 indicates a poor result and 10 indicates a good result.

aesthetic

时间窗: 1、3、6 months after surgery

The appearance assessment section of the University of Washington Quality of Life Questionnaire (UW-QOL)

次要结局

  • Incidence of postoperative complications(1、3、6 months after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Youyuan Wang

Associate Chief Physician

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

研究点 (1)

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