A Prospective Randomized Study of Reinforced Vs Non-reinforced Staple Lines in Fissureless Lobectomy
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Change in Hospital Length of Stay Due to Prolonged Air Leak (PAL)
研究概览
简要总结
Prolonged Air Leak (PAL) is a common and serious problem after lung surgery. It can lead to worse patient outcomes, longer hospital stays, and higher costs. Reinforced staplers are designed to make the staple line stronger and reduce the risk of PAL. However, investigators don't know if they are better than standard staplers, especially in a specific type of lung surgery called fissureless lobectomy for lung cancer. This study aims to find out if reinforced staplers are more effective at reducing PAL and its complications compared to non-reinforced staplers.
Reinforced staplers have been used in lung surgeries and have shown to reduce PAL. For example, staplers with special materials like polyglycolic acid (PGA) sheets have shown lower air leakage and fewer days with chest tubes. Other materials like expanded polytetrafluoroethylene (ePTFE) sleeves have also been used to manage air leaks in different types of lung surgeries. However, their effectiveness in fissureless lobectomy has not been studied yet.
详细描述
The standard definition of a PAL by the Society of Thoracic Surgeons (STS) dictates that the leak persists beyond five days; however, clinical practices commonly broaden this definition to include any instances in which the leak delays hospital discharge. Some studies find that air leaks persisting after 72 hours are indicative of PAL. Therefore, investigators have elected to use 72 hours as our benchmark for this study.
In addition to an increased hospital LOS, PAL can heighten costs, increase the incidence of readmission, and induce other postoperative complications. PAL is therefore one of the most significant complications for patients undergoing pulmonary resections, particularly lobectomy for lung cancer. PAL remains a problem despite enhancements in endoscopic surgical techniques; consequently, reinforced staplers have been developed to provide additional support to the staple line, thereby enhancing its sealing capabilities.
Reinforced staplers have been used in pulmonary surgeries, including lobectomies, and the results have shown a reduction in PAL occurrence. For example, staplers with polyglycolic acid (PGA) sheets demonstrated a lower postoperative air leakage rate and a reduction in number of chest tube days. Another study reported application of expanded polytetrafluoroethylene (ePTFE) sleeves in the management of air leaks following thoracoscopic and open lung volume reduction surgery.
The comparative effectiveness of reinforced versus non-reinforced staplers in the context of fissureless lobectomy has not yet been established. By implementing a randomized control trial design, this prospective study will attempt to fill this knowledge gap and uncover the ability of reinforced staplers to improve patient outcomes. To quantify these effects, hospital LOS will be used as a primary measure. Additional intraoperative and postoperative characteristics will be used to document any secondary benefits to reinforced staplers regarding their safety and effectiveness.
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
- None
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 aged 18 and over.
- •Patients undergoing fissureless lobectomy for lung carcinoma.
排除标准
- •Patients suitable for sub lobar resections.
- •Patients undergoing lobectomy for indications other than lung cancer.
- •Patients with a history of pleural adhesions.
- •Patients with previous lung resection on the same side.
结局指标
主要结局
Change in Hospital Length of Stay Due to Prolonged Air Leak (PAL)
时间窗: Up to 30 days post- surgery
1. The primary objective is to determine whether the use of reinforced staple lines in fissureless lobectomies will reduce the average duration of hospital length of stay directly caused by prolonged air leaks. -measured in days
次要结局
- Intraoperative Characteristics and Postoperative Outcomes(Within 30 days post-surgery)