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临床试验/NCT03413449
NCT03413449已完成不适用

A Prospective Study Frailty for Esophagectomy and Lung Resection in Thoracic Surgery

The Cleveland Clinic1 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2018年1月8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
360
试验地点
1
主要终点
Morbidity

研究概览

简要总结

The purpose of this study is to develop an all-encompassing frailty model using laboratory and functional studies. A frailty model will help us determine prior to surgery who will require rehabilitation and skilled nursing needs beyond discharge. This model will also help us determine who will likely be readmitted and why they will be readmitted. Understanding these things can help us prevent some of them from occurring in the future.

详细描述

Frailty is a widely accepted but poorly defined physical condition that has been shown to be an independent predictor of surgical morbidity and direct discharge to skilled nursing facility (SNF). Attempts have been made to study frailty in surgical patients by employing models designed for the general population. Despite the attempts of studying frailty in general surgery patients, no study has designed a model comprised of objective metrics for general thoracic surgery patients.

The purpose of this study is to better understand frailty in the context of thoracic surgery patients and to develop an objective model of this nebulous variable. It is hoped that standard, simple, functional and laboratory data can be used to construct the model with the goal being to determine the impact of frailty on outcome for patients undergoing esophagectomy, lobectomy, or pneumonectomy. If a preoperative frailty index can be developed and demonstrated to predict outcome, this scoring system may allow care teams to predict post-operative complications, ICU and hospital recidivism, and early mortality, and possibly allow for much earlier preparation for unfavorable outcomes.

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

  • All patients >18 years old who are undergoing pneumonectomy, lobectomy or esophagectomy with a cancer diagnosis over a 1-year enrollment.

排除标准

  • Patients who are unable to sign a consent.

结局指标

主要结局

Morbidity

时间窗: Assessed at discharge and will be reported through study completion, an average of 1 year

Number of STS defined complications (chest tube airleak, atelectasis, pleural effusion requiring drain, pneumonia, ARDS, respiratory failure, bronchopleural fistula, PE, pneumothorax, chylothorax, ventilator \> 48 hours, tracheostomy, tracheobronchial injury, ileus, anastomotic leak, GI dilation, conduit necrosis requiring surgery, delayed conduit emptying, C. diff, delirium) will be combined to report the number of morbidity events

Discharge status

时间窗: Assessed at discharge and will be reported through study completion, an average of 1 year

Discharge destination

次要结局

  • Length of stay(Assessed from date of surgery until the date of discharge and will be reported through study completion, an average of 1 year)
  • 30 day readmission(Assessed from date of discharge to thirty days after discharge and will be reported through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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