Reinforced and Non-Reinforced Staple Lines in Fissureless Lobectomy

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorSurrey Thoracic Surgery Group

About this trial

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.

Eligibility criteria

Qualifiers

Patients aged 18 and over.

Patients undergoing fissureless lobectomy for lung carcinoma.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Fissureless Lobectomy with Reinforced Staple Lines
  • Fissureless Lobectomy with Non-Reinforced Staple Lines

Treatment groups

65 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Surrey Thoracic Surgery Group

Lead sponsor

Johnson and Johnson Medical

Collaborator