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临床试验/NCT04451473
NCT04451473招募中不适用

The Short Term and Long Term Comparison of Lung Surgery With or Without Enhanced Recovery

The Second Hospital of Shandong University1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2019年10月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
350
试验地点
1
主要终点
the degree of pain

研究概览

简要总结

Objective: The adoption of Enhanced Recovery Surgery programs in lung resection is relatively recent with limited outcome data. This study aimed to determine the impact of an Enhanced Recovery Surgery pathway on short- term and long- term results in patients undergoing lung resection for primary lung cancer.

Methods: A Randomized Controlled Trial was designed to collect the perioperative data on consecutive patients undergoing lung resection for primary lung cancer. Patients will be randomizely assigned to the ERAS- Group and Control- Group. Short-term and long- term effect will be compared between the two groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •patients with stage I-IIIa Non-small-cell Lung Cancer underwent radical resection or other benign lung lesions need VATS surgery.

排除标准

  • •cardio-pulmonary function couldn't tolerate surgery

研究组 & 干预措施

ERAS- Group

Experimental

Patients underwent surgery for lung cancer accepted the enhanced recovery after surgery (ERAS).

干预措施: Enhanced Recovery After Surgery (ERAS ) (Procedure)

Control- Group

Other

Patients underwent surgery for lung cancer without enhanced recovery after surgery (ERAS).

干预措施: Traditional perioperative management without Enhanced Recovery After Surgery (ERAS ) (Procedure)

结局指标

主要结局

the degree of pain

时间窗: within 4 days after surgery

Visual Analogue Scale/Score

intensive care unit utilization

时间窗: within 4 days after surgery

the time in intensive care unit utilization

the time of ambulation

时间窗: within 48 hours after surgery

the time after surgery that patients could leave the bed and walk

the time for oral feed

时间窗: within 48 hours after surgery

the time for oral feed

the time of hospitalization

时间窗: within 5 days after surgery

the time of hospitalization

complications

时间窗: within 7 days after surgery

the rate of complications

次要结局

  • disease- free survival(within 5 years after surgery)
  • overall survival(within 10 years after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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