跳至主要内容
临床试验/NCT04293536
NCT04293536已完成不适用

Incidence of a Retained Surgical Device in Patients That Underwent Surgery

Assuta Medical Center2 个研究点 分布在 1 个国家目标入组 148 人开始时间: 2016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
入组人数
148
试验地点
2
主要终点
Incidence of retained devices

研究概览

简要总结

It has been estimated that in the United States alone 48 million operations are performed annually and most involve the use of multiple surgical items, including needles and other sharp objects, surgical sponges, and surgical instruments1. Textile material and instruments forgotten in a patient undergoing an invasive procedure is a negligence of an entire team responsible for maintaining patient safety. A retained surgical foreign body (RSFB) usually requires at least a second surgery for retrieval of the object, and also carries a risk for major complications including morbidity and death2. Retained foreign bodies are underreported to minimize exposure to possible litigation3. Therefore, the real occurrence of RSFB is underestimated, recently there has reported an incidence of 0.356 / 1,000 patients whereas others reported a rate of 1/5000 with an associated mortality ranging from 11 to 35% 4-5.

Therefore, there is a need for improved systems and methods for identifying and tracking surgical items, including needles and other sharp objects, surgical sponges, and surgical instruments during a surgical procedure.

详细描述

All cases investigated due to retained material during hospital surgical treatment will be included. Incidence, type of procedure performed, the prevalence and guilty of the personal actuating will be considered.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Any patient who during internment for surgery had an accident of forgetfulness in the material used for their treatment.

排除标准

  • No exclusion criteria

结局指标

主要结局

Incidence of retained devices

时间窗: three years

Cases with retained devices or almost accident will be considered

次要结局

  • Type of devices(3 years)

研究者

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

Sergio Gabriel Susmallian

Medicine Doctor

Assuta Medical Center

研究点 (2)

Loading locations...

相似试验