PMID- 20541949
OWN - NLM
STAT- MEDLINE
DCOM- 20110728
LR  - 20220410
IS  - 1873-734X (Electronic)
IS  - 1010-7940 (Linking)
VI  - 38
IP  - 6
DP  - 2010 Dec
TI  - Efficacy and safety of TachoSil(R) versus standard treatment of air leakage after 
      pulmonary lobectomy.
PG  - 683-9
LID - 10.1016/j.ejcts.2010.03.061 [doi]
AB  - OBJECTIVES: 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(R), 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(R) 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(R), n=148; standard treatment, n=151). TachoSil(R) resulted in a reduction 
      in the duration of postoperative air leakage (p=0.030). Patients in the TachoSil(R) 
      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(R) 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(R) 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.
CI  - Copyright (c) 2010 European Association for Cardio-Thoracic Surgery. Published by 
      Elsevier B.V. All rights reserved.
FAU - Marta, Gabriel Mihai
AU  - Marta GM
AD  - Vienna University Hospital, Vienna, Austria.
FAU - Facciolo, Francesco
AU  - Facciolo F
FAU - Ladegaard, Lars
AU  - Ladegaard L
FAU - Dienemann, Hendrik
AU  - Dienemann H
FAU - Csekeo, Attila
AU  - Csekeo A
FAU - Rea, Federico
AU  - Rea F
FAU - Dango, Sebastian
AU  - Dango S
FAU - Spaggiari, Lorenzo
AU  - Spaggiari L
FAU - Tetens, Vilhelm
AU  - Tetens V
FAU - Klepetko, Walter
AU  - Klepetko W
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20100611
PL  - Germany
TA  - Eur J Cardiothorac Surg
JT  - European journal of cardio-thoracic surgery : official journal of the European 
      Association for Cardio-thoracic Surgery
JID - 8804069
RN  - 0 (Drug Combinations)
RN  - 0 (TachoSil)
RN  - 0 (Tissue Adhesives)
RN  - 9001-32-5 (Fibrinogen)
RN  - EC 3.4.21.5 (Thrombin)
SB  - IM
CIN - Eur J Cardiothorac Surg. 2010 Dec;38(6):689-90. PMID: 20537550
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - *Air
MH  - Chest Tubes
MH  - Drainage
MH  - Drug Combinations
MH  - Female
MH  - Fibrinogen/*therapeutic use
MH  - Humans
MH  - Length of Stay/statistics & numerical data
MH  - Lung Neoplasms/*surgery
MH  - Male
MH  - Middle Aged
MH  - Pneumonectomy/*adverse effects/methods
MH  - Pneumothorax/prevention & control
MH  - Postoperative Care/methods
MH  - Postoperative Complications
MH  - Prospective Studies
MH  - Surgical Sponges
MH  - Surgical Stapling
MH  - Suture Techniques
MH  - Thrombin/*therapeutic use
MH  - Time Factors
MH  - Tissue Adhesives/*therapeutic use
MH  - Treatment Outcome
EDAT- 2010/06/15 06:00
MHDA- 2011/07/29 06:00
CRDT- 2010/06/15 06:00
PHST- 2009/12/06 00:00 [received]
PHST- 2010/03/21 00:00 [revised]
PHST- 2010/03/29 00:00 [accepted]
PHST- 2010/06/15 06:00 [entrez]
PHST- 2010/06/15 06:00 [pubmed]
PHST- 2011/07/29 06:00 [medline]
AID - S1010-7940(10)00341-6 [pii]
AID - 10.1016/j.ejcts.2010.03.061 [doi]
PST - ppublish
SO  - Eur J Cardiothorac Surg. 2010 Dec;38(6):683-9. doi: 10.1016/j.ejcts.2010.03.061. 
      Epub 2010 Jun 11.