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临床试验/NCT05474261
NCT05474261已完成不适用

Clinical Usefulness of the Valsalva Maneuver to Improve Hemostasis During Thyroidectomy

University of Foggia1 个研究点 分布在 1 个国家目标入组 178 人开始时间: 2019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
178
试验地点
1
主要终点
Volume of cervical drainage after total thyroidectomy

研究概览

简要总结

Bleeding after total thyroidectomy remains a rare event that affects early postoperative morbidity, occurring in 0.3% up to 4.2% of cases. Intraoperative bleeding is an unpleasant complication, and it is often easily manageable though postoperative bleeding may represent a life-threatening condition for the patient.

Between January 2019 to February 2022 , 250 consecutive patients were listed for thyroidectomy. The Investigators selected 178 patients and divided them in two groups based on the execution of the Valsalva Manoeuvre.

The purpose of the investigator is to clarify whether the routine intraoperative execution of a Valsalva manoeuvre (VM) may affect the detection of bleeding that would otherwise remain occult and therefore may manifest in the postoperative period.

研究设计

研究类型
Observational
观察模型
Case Control
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

  • thyroid diseases

排除标准

  • lymph node dissection
  • minimally invasive approaches
  • high anesthesiological risk

结局指标

主要结局

Volume of cervical drainage after total thyroidectomy

时间窗: 24 hours

Bleeding after thyroidectomy is evaluated based on the total volume of cervical drainage output (ml)

Number of reinterventions

时间窗: 24 hours

Reoperations to resolve post thyroidectomy bleeding, which can cause airway compression and choking signs and symptoms.

次要结局

未报告次要终点

研究者

发起方
University of Foggia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mario Pacilli

Principal Investigator

University of Foggia

研究点 (1)

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