Patient undergone lobectomy or segmentectomy (anatomical segmentectomy) for lung carcinoma and that during intraoperative phase after first suture with stapler show air leakage with grade 1-2 according to the Macchiarini scale. MedDRA version: 9.1 Level: SOC Classification code 10038738
Conditions
Interventions
Trade Name: TACHOSIL
Pharmaceutical Form: Sealant
INN or Proposed INN: FIBRINOGENO UMANO
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5,5-
INN or Proposed INN: T
Sponsors
AZIENDA UNITA` SANITARIA LOCALE LECCE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Giving Written Informed Consent - Male and female patients - Age >= 18 years - Lobectomy, bilobectomy superior or inferior right, anatomical segmentectomy in patients with malignant carcinoma. If lobectomy was performed, it is mandatory to use stapler for scissures (not electrocautery) - If anatomical segmentectomy was performed, it is mandatory the use of stapler - Macchiarini score 1 or 2 after lobectomy 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: - Previous radio-chemotherapy - Videoassisted surgery - Previous chest surgery - Important pleural adhesions - Emergency surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This is an open, randomized, prospective study in comparison with standard surgery procedures. The study will be conducted in 17 Thoracic Surgery Units with the aim to evaluate the efficacy of TachoSil application on parenchimal air leakage and to determine its effects on the reduction of incidence/severity intraoperative air leakage, duration of thoracic drainage, duration of post-operative air leakage and hospitalization period.;Secondary Objective: not avalaible;Primary end point(s): Intaoperative air leakage reduction of 1 or 2 degree (from 1 to 0 or from 2 to 1 to 0) estimate with the second water submersion test (Macchiarini test) post-treatment. | — |
Countries
Italy
Outcome results
None listed