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NCT06602661Not yet recruitingPhase 1

Reinforced and Non-Reinforced Staple Lines in Fissureless Lobectomy

A Prospective Randomized Study of Reinforced Vs Non-reinforced Staple Lines in Fissureless Lobectomy

Source: ClinicalTrials.gov · Last updated 19 Sept 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
65 (estimated)
First submitted
13 Sept 2024
Start date
1 Jan 2025
Primary completion date
Jan 2028
Lead sponsor
Surrey Thoracic Surgery Group
Diseases
Lung cancer
NCT number
NCT06602661

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 65
  • From 1 Jan 2025 to the primary completion date, Jan 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients with previous lung resection on the same side.

Other illness

  • Patients undergoing lobectomy for indications other than lung cancer.
  • Patients with a history of pleural adhesions.

Other

  • Patients suitable for sub lobar resections.

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Surrey Thoracic Surgery Group
Coordinator of this site? Confirm its status
SurreyCanadaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.