Reinforced and Non-Reinforced Staple Lines in Fissureless Lobectomy

Phase 1

Not yet recruiting

• Conditions: Lung; Lung Adenocarcinoma; Lung Adenosquamous Carcinoma; Lung Cancer, Non-Small Cell; Lung Carcinoma; Lobectomy; Lobectomy Patient; Lobectomy by Video-thoracoscopies; VATS

• Registration Number: NCT06602661
• Lead Sponsor: Surrey Thoracic Surgery Group

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-13
• Study First Submitted QC: 2024-09-17
• Last Update Submitted: 2024-09-17
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19
• Study Start: 2025-01-01
• Primary Completion: 2028-01
• Study Completion: 2028-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

• Patients aged 18 and over.
• Patients undergoing fissureless lobectomy for lung carcinoma.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Hospital Length of Stay Due to Prolonged Air Leak (PAL)	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

Secondary Outcome Measures

Name	Time	Method
Intraoperative Characteristics and Postoperative Outcomes	Within 30 days post-surgery	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

Trial Locations

Locations (1)

Surrey Thoracic Surgery Group; 🇨🇦 Surrey, B.C, Canada