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临床试验/NCT06452680
NCT06452680尚未招募不适用

The Effect of Preserving Inferior Pulmonary Ligamen on Symptom Burden and Clinical Outcomes in Thoracoscopic Pneumonectomy

Guangdong Provincial People's Hospital5 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年6月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
200
试验地点
5
主要终点
Cough score postoperation

研究概览

简要总结

The investigators conducted a muti-centres randomized controlled clinical trial to explore the effect of preservation of inferior pulmonary ligment compared with dissection.

详细描述

Dissection of the inferior pulmonary ligament (IPL) has been a common practice in upper lobectomy to facilitate the expansion of the remaining lung, reduce dead space after resection, and minimize complications such as pleural effusion and pulmonary infection. However, studies have found that IPL dissection does not improve patient outcomes. On the contrary, releasing the restriction may lead to excessive movement of the remaining lobes, resulting in significant changes in bronchial angles and lung volume, which can worsen pulmonary function and increase postoperative symptoms. Most existing studies are retrospective, providing relatively low-level evidence. Moreover, previous research has primarily focused on radiographic outcomes and pulmonary function tests results, while the effect on patients' symptom burden has been largely overlooked. From the patient's perspective, symptom burden might be more significant, reflecting the clinical value of changes in radiographic and functional indices. In this study, the investigators applied patient-reported outcomes to measure symptoms. Combined with pulmonary function results and radiological outcomes, the investigators compared the clinical value of preserving versus dissecting the IPL in upper lobectomy.

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
Triple (Participant, Care Provider, Outcomes Assessor)

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

  • Patients underwent upper lobe resection
  • Patients could complete our questionnaires

排除标准

  • Previous history of ipsilateral lung surgery
  • Patients who underwent pleurodesis

结局指标

主要结局

Cough score postoperation

时间窗: up to 3 months

The investigators used PSA-LUNG questionnaire to assess patients symptom burden after surgery. Changing of cough score during 1 month postoperation was chosen as the primary outcome.

次要结局

  • Other Symptom burden postoperation PSA-LUNG questionnaire(up to 3 months)
  • Radiological outcome(Day 1 after surgery; 1 month after discharge; 3 months after discharge)

研究者

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

GuiBin Qiao

Professor of Medicine

Guangdong Provincial People's Hospital

研究点 (5)

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