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临床试验/NCT02486393
NCT02486393已完成不适用

Complications in Parotid Surgery - a Prospective Cohort Study

Helsinki University Central Hospital0 个研究点目标入组 178 人开始时间: 2011年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
178
主要终点
facial palsy

研究概览

简要总结

The investigators conducted a prospective study of 132 patients undergoing benign parotid surgery at our department. Their primary objective was to analyze the incidence of and contributing factors associated with temporary and permanent postoperative facial palsy with strictly standardized methods in facial nerve function evaluation. Also other complications occurring within 12 months of operation were recorded.

详细描述

Patients who underwent parotid surgery at the Department of Otorhinolaryngology - Head and Neck Surgery, Helsinki University Hospital, Helsinki, Finland, between September 2011 and November 2012 were prospectively enrolled. Exclusion criteria were age under 18, suspicion of malignancy or facial schwannoma, a tumor extending into the parapharyngeal space, and previous parotid surgery exposing facial nerve.

研究设计

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

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

  • parotid gland tumour surgery

排除标准

  • age under 18
  • suspicion of malignancy or facial schwannoma
  • a tumor extending into the parapharyngeal space
  • previous parotid surgery exposing facial nerve

结局指标

主要结局

facial palsy

时间窗: post op 12 months

次要结局

未报告次要终点

研究者

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

Leif Bäck

MD PhD

Helsinki University Central Hospital

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