The Effect of Preserving Inferior Pulmonary Ligamen on Symptom Burden and Clinical Outcomes in Thoracoscopic Pneumonectomy
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
- 否
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
GuiBin Qiao
Professor of Medicine
Guangdong Provincial People's Hospital
