Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06602661
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-13
Brief Title:
Reinforced and Non-Reinforced Staple Lines in Fissureless Lobectomy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Randomized Study of Reinforced Vs Non-reinforced Staple Lines in Fissureless Lobectomy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 dont 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None