跳至主要内容
临床试验/NCT04886440
NCT04886440已完成不适用

Predictive Value of the Sialendoscopy in Treatment of Submandibular Gland Sialolithiasis: a Retrospective Study

Centre Hospitalier Régional Metz-Thionville1 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
138
试验地点
1
主要终点
Recurrence of symptom

研究概览

简要总结

Salivary disorders are common reason for ENT specialist consultation. Sialolithiasis are the most frequent salivary obstruction disease and are characterized by the development of calcified structures in the salivary gland, especially in the submandibular gland.

The management of salivary obstruction has changed over the past 30 years. Sialendoscopy is considered as a minimally invasive procedure that allows endoscopic visualization of the salivary ductal system and is increasingly used in both diagnosis and treatment. Moreover, many studies have shown the effectiveness of this procedure.

Classification of lithiasis has been set up in 2008 to standardize the nomenclature and was used for patient care since 2009. The main objective of this study is to evaluate the relevance of the lithiasis's classification to predict the efficacy of sialendoscopy in treatment of sialolithiases.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

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

入选标准

  • Adult patient
  • Patient treated in CHR Metz-Thionville between 2013 and 2020
  • With a pathological impairment (suspected or confirmed) of a salivary gland
  • With sialendoscopy indication for diagnosis and/or treatment

排除标准

  • Opposed to use data
  • Without sialendoscopy indication
  • Without lithiasis salivary gland disorder
  • With parotid gland lithiasis

结局指标

主要结局

Recurrence of symptom

时间窗: Month 6

Absence or presence of symptoms associated to lithiasis

次要结局

  • Number of intraoperative complications(Day 1)
  • Number of clinical signs(Day 1)
  • Number of post-operative complications(Day 1)

研究者

发起方
Centre Hospitalier Régional Metz-Thionville
申办方类型
Other
责任方
Sponsor

研究点 (1)

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