Efficacy and safety of TachoSil® versus standard treatment of air leakage after pulmonary lobectomy.
OBJECTIVE
Alveolar air leakage remains a serious problem in lung surgery, being associated with increased postoperative morbidity, prolonged hospital stay and greater health-care costs. The aim of this study was to evaluate the sealing efficacy and safety of the surgical patch, TachoSil®, in lung surgery.


METHODS
Patients undergoing elective pulmonary lobectomy who had grade 1 or 2 air leakage (evaluated by the water submersion test) after primary stapling and limited suturing were randomised at 12 European centres to open-label treatment with TachoSil® or standard surgical treatment (resuturing, stapling or no further treatment at the surgeons' discretion). Randomisation was performed during surgery using a centralised interactive voice response system. Duration of postoperative air leakage (primary end point), reduction of intra-operative air leakage intensity (secondary end point) and adverse events (AEs), including postoperative complications, were assessed.


RESULTS
A total of 486 patients were screened and 299 received trial treatment (intent-to-treat (ITT) population: TachoSil®, n=148; standard treatment, n=151). TachoSil® resulted in a reduction in the duration of postoperative air leakage (p=0.030). Patients in the TachoSil® group also experienced a greater reduction in intra-operative air leakage intensity (p=0.042). Median time until chest drain removal was 4 days with TachoSil® and 5 days in the standard group (p=0.054). There was no difference between groups in hospital length of stay. AEs were generally similar in both groups, including postoperative complications.


CONCLUSIONS
TachoSil® was superior to standard surgical treatment in reducing both postoperative air leakage duration and intra-operative air leakage intensity in patients undergoing elective pulmonary lobectomy.
Marta
Gabriel Mihai
GM
Vienna University Hospital, Vienna, Austria.
Facciolo
Francesco
F
Ladegaard
Lars
L
Dienemann
Hendrik
H
Csekeo
Attila
A
Rea
Federico
F
Dango
Sebastian
S
Spaggiari
Lorenzo
L
Tetens
Vilhelm
V
Klepetko
Walter
W
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000388:Air; D015505:Chest Tubes; D004322:Drainage; D004338:Drug Combinations; D005260:Female; D005340:Fibrinogen / Q000627:therapeutic use*; D006801:Humans; D007902:Length of Stay / Q000706:statistics & numerical data; D008175:Lung Neoplasms / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D011013:Pneumonectomy / Q000009:adverse effects* / Q000379:methods; D011030:Pneumothorax / Q000517:prevention & control; D011182:Postoperative Care / Q000379:methods; D011183:Postoperative Complications; D011446:Prospective Studies; D015503:Surgical Sponges; D017792:Surgical Stapling; D013536:Suture Techniques; D013917:Thrombin / Q000627:therapeutic use*; D013997:Time Factors; D014014:Tissue Adhesives / Q000627:therapeutic use*; D016896:Treatment Outcome
D004338:Drug Combinations; C518955:TachoSil; D014014:Tissue Adhesives; D005340:Fibrinogen; D013917:Thrombin