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临床试验/NCT03888079
NCT03888079已完成不适用

Patient Satisfaction After Surgery for Otosclerosis Under Local ou General Anesthesia

Rennes University Hospital1 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2019年1月11日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
103
试验地点
1
主要终点
Visual comfort scale (EVA type ruler)

研究概览

简要总结

Main purpose of this study is to compare comfort level of patients, after otosclerosis surgery, under local or general anesthesia.

详细描述

The care system will not differ from the usually treatment of patients. Patients will decided about the type of anesthesia (local or general) after detailed description of both procedures.

All operations will be performed by the same surgeon and the same basic surgical technique.

The only difference is that patients included in thi study will have to complete a satisfactory survey 10 days after surgery and a GBI questionnaire 3 months after surgery, during the post operative consultations .

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

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Local anesthetic

Patients who chose local anesthesia for their surgery

干预措施: Local anesthetic (Drug)

General anesthetic

Patients who chose general anesthesia for their surgery

干预措施: general anesthetic (Drug)

结局指标

主要结局

Visual comfort scale (EVA type ruler)

时间窗: 10 days after surgery

respondents specify their level of comfort during the surgery by indicating a position along a continuous line between two end-points : Minimum score is 0 (no comfort) and maximum is 10 (very comfortable) during surgery

次要结局

  • Glasgow Benefit Inventory questionnaire GBI(3 months after surgery)

研究者

发起方
Rennes University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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