Patients undergone to lobectomy for non-small cell lung cancer (NSCLC) performed through posterolateral or anterolateral thoracotomy and that during intraoperative phase after first suture with staples show air leakage with grade 1-2 according to the Macchiarini scale. MedDRA version: 9.1 Level: LLT Classification code 10030860 Term: Operative haemorrhage
Conditions
Sponsors
AZIENDA OSPEDALIERA SENESE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male and female patients - Age > 18 years - Giving informed consent - Lobectomy for NSCLC - Macchiarini score 1-2 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Neoadjuvant therapy - Non oncological surgery - Videoassisted surgery - Previous chest surgery - Important intrapleural adhesions - Any other surgery resection besides lobectomy - Emergency surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of TachoSil application on parenchimal air leakage and to determine its effects on time to chest drain removal and duration of hospitalization.;Secondary Objective: - Lasting of air leakage (days) - Time to chest drain removal (days) - Volume of pleural fluid drained (every 24 hours and cumulative) - Hospitalization lenght (days) - Intensity of intraoperative air leakage post-treatment according to Macchiarini scale;Primary end point(s): - Intensity of post-operative air leakage espressed as area under the curve (AUC) | — |
Countries
Italy
Outcome results
None listed