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.
Patients aged 18 and over.
Patients undergoing fissureless lobectomy for lung carcinoma.
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.
Parallel
Fissureless Lobectomy with Reinforced Staple Lines
Procedure/SurgeryThis intervention involves performing a fissureless lobectomy, a type of lung surgery where the lobes of the lung are removed without dissecting the fissures between them. The procedure utilizes the ECHELON™ 3000 stapler equipped with the ENDOPATH™ stapler line reinforcement. The ENDOPATH™ device uses bioabsorbable buttress material made from Polyglactin and Polydioxanone, designed to enhance the durability and effectiveness of the staple line. The reinforcement tool is a novel preloaded device with a "click and go" mechanism, making it easy to load and use during surgery. The primary objective is to reduce the average duration of hospital length of stay (LOS) directly caused by prolonged air leak (PAL). Secondary objectives include improving intraoperative characteristics (such as duration and amount of blood loss) and postoperative outcomes (such as incidence and duration of PALs, number of chest tube days, and incidence of hospital.
Fissureless Lobectomy with Non-Reinforced Staple Lines
Procedure/SurgeryThis intervention involves performing a fissureless lobectomy, a type of lung surgery where the lobes of the lung are removed without dissecting the fissures between them. The procedure utilizes the ECHELON™ 3000 stapler without any additional reinforcement. This means the staple lines are created using the standard stapler without the use of bioabsorbable buttress materials. The ECHELON™ 3000 stapler is used to divide the lung parenchyma, pulmonary artery branches, veins, and bronchus without any reinforcement, relying solely on the standard stapling mechanism.
Change in Hospital Length of Stay Due to Prolonged Air Leak (PAL)
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
Intraoperative Characteristics and Postoperative Outcomes
1\. The number or percentage of patients experiencing prolonged air leaks postoperatively. * measured by number or Percentage 2. The duration of prolonged air leaks in days. * Measured in Days 3. The total number of days each patient has a chest tube in place postoperatively. * Measured in Days 4. The number or percentage of patients readmitted to the hospital within 30 days post-surgery. * Measured in number or Percentage
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Surrey Thoracic Surgery Group
Lead sponsor
Johnson and Johnson Medical
Collaborator
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