title: Medical and Economic Evaluation of FOREseal Bioabsorbable Reinforcement Sleeves Compared With Current Standard of Care for Reducing Air Leakage Duration After Lung Resection for Malignancy: A Randomized Trial.
abstract: The objective of this study was to determine the efficacy of alginate staple-line reinforcement of fissure openings as compared with stapling alone, with or without tissue sealant or glue, in reducing the incidence and duration of air leakage after pulmonary lobectomy for malignancy.
  
  
  
  No randomized trial evaluating alginate staple-line reinforcement has been performed to date.
  
  
  
  The Staple-line Reinforcement for Prevention of Pulmonary Air Leakage study was a multicenter randomized trial, with blinded evaluation of endpoints. Patients over 18 years of age scheduled for elective open lobectomy or bilobectomy for malignancy were eligible for enrollment. At thoracotomy, patients were deemed ineligible if an unanticipated pneumonectomy was indicated, or if air leakage occurred after the liberation of pleural adhesions. Otherwise, if the fissure was incomplete or the lung had an emphysematous appearance, patients were randomized to either standard management or interventional procedure consisting of fissure opening with linear cutting staplers buttressed with paired alginate sleeves (FOREseal). The number of eligible patients necessary in each randomization arm was estimated to be 190, and an outcomes analysis was performed on an intention-to-treat basis.
  
  
  
  Of the 611 patients consented to study enrollment, 380 met the inclusion criteria and were randomized. Based on an intention-to-treat analysis, the primary endpoint of air leak duration was not different between the 2 groups: 1 day (range: 0-2 d) in the FOREseal group and 1 day (range: 0-3 d) in the control group (P = 0.8357). In addition, the 2 groups were similar in terms of the proportion of patients presenting with prolonged air leakage (7.8% in the FOREseal group vs 11.3% in the control group, P = 0.264) and the average duration of chest drainage (P = 0.107). Procedure costs were comparable for both groups.
  
  
  
  FOREseal did not demonstrate a significant advantage over standard treatment alone.
authors.affiliation: *Department of Thoracic Surgery, Paris Center University Hospital, Paris Descartes University, Paris, France †Department of Thoracic Surgery, Poitiers University Hospital, Poitiers, France ‡Department of Thoracic Surgery, Limoges University Hospital, Limoges, France §Department of Thoracic Surgery, Institute Mutualiste Montsouris, Paris, France ||Department of Thoracic Surgery, Bichat University Hospital, Paris Diderot University, Paris, France ¶Department of Thoracic Surgery, St Etienne University Hospital, St Etienne, France #Department of Thoracic Surgery, Dijon University Hospital, Dijon, France **Department of Thoracic Surgery, Lyon University Hospital, Bron, France ††Department of Thoracic Surgery, Grenoble University Hospital, Grenoble, France ‡‡Department of Thoracic Surgery, Tours University Hospital, Tours, France §§Department of Thoracic Surgery, Nancy University Hospital, Nancy, France ||||Department of Thoracic Surgery, Clinique du Cedre, Rouen, France ¶¶Department of Biostatistics, Paris West University Hospital, Paris, France ##Department of Public Health and Medical Economy, Paris Center University Hospital, Paris, France ***Department of Thoracic Surgery, Paris West University Hospitals, AP-HP, Paris Descartes University, Paris, France.
authors.forename: Marco
authors.initials: M
authors.lastname: Alifano
authors.forename: Christophe
authors.initials: C
authors.lastname: Jayle
authors.forename: François
authors.initials: F
authors.lastname: Bertin
authors.forename: Pierre
authors.initials: P
authors.lastname: Magdeleinat
authors.forename: Yves
authors.initials: Y
authors.lastname: Castier
authors.forename: Olivier
authors.initials: O
authors.lastname: Tiffet
authors.forename: Alain
authors.initials: A
authors.lastname: Bernard
authors.forename: François
authors.initials: F
authors.lastname: Tronc
authors.forename: Pierre-Yves
authors.initials: PY
authors.lastname: Brichon
authors.forename: Pascal
authors.initials: P
authors.lastname: Dumont
authors.forename: Gilles
authors.initials: G
authors.lastname: Grosdidier
authors.forename: Antoine
authors.initials: A
authors.lastname: Dujon
authors.forename: Abel
authors.initials: A
authors.lastname: Grine
authors.forename: Helena
authors.initials: H
authors.lastname: Pereira
authors.forename: Anais
authors.initials: A
authors.lastname: Le Jeannic
authors.forename: Marie Amélie
authors.initials: MA
authors.lastname: Vinet
authors.forename: Hassani
authors.initials: H
authors.lastname: MaOulida
authors.forename: Isabelle
authors.initials: I
authors.lastname: Durand-Zaleski
authors.forename: Marc
authors.initials: M
authors.lastname: Riquet
authors.forename: Gilles
authors.initials: G
authors.lastname: Chatellier
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Regnard
mesh_terms: D020341:Absorbable Implants; D000230:Adenocarcinoma / Q000601:surgery; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000464:Alginates / Q000008:administration & dosage*; D001672:Biocompatible Materials / Q000008:administration & dosage*; D018287:Carcinoma, Large Cell / Q000601:surgery; D002294:Carcinoma, Squamous Cell / Q000601:surgery; D005260:Female; D020723:Glucuronic Acid / Q000008:administration & dosage; D006603:Hexuronic Acids / Q000008:administration & dosage; D006801:Humans; D057194:Intention to Treat Analysis; D007391:International Cooperation; D008175:Lung Neoplasms / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D011013:Pneumonectomy / Q000379:methods*; D011030:Pneumothorax / Q000209:etiology / Q000517:prevention & control*; D011183:Postoperative Complications / Q000517:prevention & control*; D011446:Prospective Studies; D016037:Single-Blind Method; D055752:Small Cell Lung Carcinoma / Q000601:surgery; D059039:Standard of Care; D017792:Surgical Stapling; D013997:Time Factors; D014014:Tissue Adhesives / Q000008:administration & dosage; D058106:Wound Closure Techniques
chemical_list: D000464:Alginates; D001672:Biocompatible Materials; D006603:Hexuronic Acids; D014014:Tissue Adhesives; D020723:Glucuronic Acid