title: Prospective randomized trial comparing buttressed versus nonbuttressed stapling in patients undergoing pulmonary lobectomy.
abstract: BACKGROUND
  The aim of this study was to evaluate the efficacy of buttressed stapling using a stapler with an attached polyglycolic acid sheet in reducing the rate of air leak associated with pulmonary lobectomy. Materials and
  
  
  METHODS
  A prospective, randomized, phase III study was conducted to confirm the superiority of a buttressed stapler in a test treatment group to a conventional nonbuttressed stapler in a current international standard of care group among patients undergoing pulmonary lobectomy. The primary end point was the frequency of intraoperative air leaks.
  
  
  RESULTS
  Although no fatal postoperative bleeding occurred in the present study, this trial closed early with 100 patients because the manufacturer recalled the buttressed stapler based on reports of 13 serious injuries and 3 fatalities following pulmonary resection in routine clinical practice. A total of 76 patients treated with a stapler (35 in the non-B group and 41 in the B group) were included as subjects in the analysis. No statistical differences were observed between the groups in the frequency of intraoperative air leaks (22 [63%] vs. 26 [63%]) or the postoperative duration of air leaks (mean: 3.5 vs. 2.9 days). The frequency of air leak from stapler holes was significantly lower in the B group than in the non-B group (2% [1/41] vs. 20% [7/35]; p=0.016).
  
  
  CONCLUSIONS
  The efficacy of buttressed stapling in reducing the rate of air leak in patients undergoing pulmonary lobectomy could not be clearly demonstrated. However, air leak from stapler holes can be prevented with buttressed stapling.
authors.affiliation: Department of General Thoracic Surgery, Juntendo University School of Medicine, Tokyo, Bunkyo-Ku, Japan.
authors.forename: Kazuya
authors.initials: K
authors.lastname: Takamochi
authors.affiliation: Department of General Thoracic Surgery, Juntendo University School of Medicine, Tokyo, Bunkyo-Ku, Japan.
authors.forename: Shiaki
authors.initials: S
authors.lastname: Oh
authors.affiliation: Department of General Thoracic Surgery, Juntendo University School of Medicine, Tokyo, Bunkyo-Ku, Japan.
authors.forename: Yoshikazu
authors.initials: Y
authors.lastname: Miyasaka
authors.affiliation: Department of General Thoracic Surgery, Juntendo University School of Medicine, Tokyo, Bunkyo-Ku, Japan.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Matsunaga
authors.affiliation: Department of General Thoracic Surgery, Juntendo University School of Medicine, Tokyo, Bunkyo-Ku, Japan.
authors.forename: Yoshitaka
authors.initials: Y
authors.lastname: Kitamura
authors.affiliation: Department of General Thoracic Surgery, Juntendo University School of Medicine, Tokyo, Bunkyo-Ku, Japan.
authors.forename: Mariko
authors.initials: M
authors.lastname: Fukui
authors.affiliation: Department of General Thoracic Surgery, Juntendo University School of Medicine, Tokyo, Bunkyo-Ku, Japan.
authors.forename: Kenji
authors.initials: K
authors.lastname: Suzuki
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D057239:Early Termination of Clinical Trials; D005260:Female; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D011013:Pneumonectomy / Q000009:adverse effects / Q000379:methods*; D011030:Pneumothorax / Q000209:etiology; D011446:Prospective Studies; D012307:Risk Factors; D017792:Surgical Stapling / Q000009:adverse effects / Q000379:methods*; D013997:Time Factors; D016896:Treatment Outcome