NCT06775873已完成不适用
Modified Diaphragmatic Plication Rectifies Dyspnea With Diaphragmatic Eventration Caused by Phrenicotomy or Injuries Involved in Extended Mediastinal Surgeries
Tongji University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年2月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Effective rates of prevention of diaphragmatic elevation
研究概览
简要总结
Traditional diaphragmatic plication (DP) surgery is employed to ameliorate respiratory function in patients with diaphragmatic paralysis, which is rather complicated. This study introduces a modified method of DP. The efficacy of modified diaphragmatic plication (MDP) in preventing, treating, and relieving dyspnea in patients with phrenic nerve resection or injury due to extensive surgical intervention or local tumor invasion will be evaluated.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preoperative chest X-ray suggesting diaphragmatic eventration, for which therapeutic MDP was performed;
- •Mediastinal tumors encircling the phrenic nerve that could not be dissected or phrenic nerve injury occurring during intraoperative dissection, for which prophylactic MDP was performed;
- •Diaphragmatic eventration and dyspnea following mediastinal surgery, for which salvage MDP was performed.
排除标准
- •Congenital diaphragmatic deformity or diaphragmatic weakness due to poor general nutritional status;
- •Morbid obesity with a BMI greater than 35 kg/m2;
- •Neuromuscular diseases, including amyotrophic lateral sclerosis and myasthenia gravis;
- •A history of upper abdominal surgery; and (5) Diaphragmatic calcification or fibrosis.
结局指标
主要结局
Effective rates of prevention of diaphragmatic elevation
时间窗: 1 year
Success in correcting diaphragmatic elevation
时间窗: 1 year
次要结局
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(1 year)
研究者
Jiang Fan
professor
Tongji University
研究点 (1)
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