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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Surrey Thoracic Surgery Group Coordinator of this site? Confirm its status | Surrey | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.