Status:
COMPLETED
Staple-line Reinforcement for Prevention of Pulmonary Air Leakage
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Lung Neoplasms
Pulmonary Surgical Procedures
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief Summary
The aim of this study is to compare the efficacy of FORESEAL with stapling alone or associated with tissue sealant or glue in terms of air leakage duration after lung resection for cancer. Hypothesis...
Detailed Description
Air leaks continue to be the most common complication after pulmonary resection even using a stapling device. Double chest tubes after lobectomy is a well established method for drainage of the pleura...
Eligibility Criteria
Inclusion
- Patient 18 years old or over.
- Patient that undergoes a lobectomy or bilobectomy for lung cancer,
- Patient presenting an incomplete fissure, requiring stapling of at least 50% of the fissure and/or an emphysematous lung at the fissure point, requiring stapling.
- Patient that has signed the informed consent before the operation.
- Patient that benefits from a social security regime.
Exclusion
- Patient with history of thoracotomy on the side operated on.
- Patient with severe pleural infection and/or infection of parenchyma.
- Presence of air leakage after liberation of lung in cases of pleural symphysis.
- Patient pregnant, giving birth or nursing.
- Patient presenting a contra indication to the aerostatic products used.
- Patient already participating in biomedical research.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
380 Patients enrolled
Trial Details
Trial ID
NCT00925444
Start Date
June 1 2009
End Date
March 1 2013
Last Update
September 18 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Assistance Publique Hopitaux de Paris
Paris, France, 75000