Lung Neoplasms Clinical Trial
Official title:
Medical and Economic Evaluation of FORESEAL Versus the Current Therapeutic Approach (Stapling Alone or Associated With Tissue Sealant) in Terms of Air Leakage Duration After Lung Resection for Cancer.
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: to show a significant difference of 1 day in the average duration of air leakage
between the 2 groups with a standard deviation of 3 (α =0.05 and β=0.10).
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 pleural cavity to allow adequate expansion of the remaining lung.
FORESEAL has been developed to reduce air leaks by buttressing the staple line. It is a
absorbable vegetal biopolymer in the form of sleeves, CE marked and indicated for prevention
of air leakage after pulmonary resection with stapling device. It acts as a suture
reinforcement as well as a sealant thanks to its jellification.
Sealants are also commonly used in addition to stapling to prevent air leakage. The aim of
this study is to compare the efficacy of FORESEAL with stapling alone or associated with
sealants.
This is a multi centre, prospective controlled and randomised clinical study.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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