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.

Keywords

lung cancer treatment - surgery - complications - surgical equipment

• References

• 1 Macchiarini P, Wain J, Almy S, Dartevelle P. Experimental and clinical evaluation of a new synthetic, absorbable sealant to reduce air leaks in thoracic operations. J Thorac Cardiovasc Surg 1999; 117 (4) 751-758
• 2 Okereke I, Murthy SC, Alster JM, Blackstone EH, Rice TW. Characterization and importance of air leak after lobectomy. Ann Thorac Surg 2005; 79 (4) 1167-1173
• 3 Loran DB, Woodside KJ, Cerfolio RJ, Zwischenberger JB. Predictors of alveolar air leaks. Chest Surg Clin N Am 2002; 12 (3) 477-488
• 4 Liang S, Ivanovic J, Gilbert S , et al. Quantifying the incidence and impact of postoperative prolonged alveolar air leak after pulmonary resection. J Thorac Cardiovasc Surg 2013; 145 (4) 948-954
• 5 Brunelli A, Monteverde M, Borri A, Salati M, Marasco RD, Fianchini A. Predictors of prolonged air leak after pulmonary lobectomy. Ann Thorac Surg 2004; 77 (4) 1205-1210 , discussion 1210
• 6 Cerfolio RJ, Bass CS, Pask AH, Katholi CR. Predictors and treatment of persistent air leaks. Ann Thorac Surg 2002; 73 (6) 1727-1730 , discussion 1730–1731
• 7 Irshad K, Feldman LS, Chu VF, Dorval JF, Baslaim G, Morin JE. Causes of increased length of hospitalization on a general thoracic surgery service: a prospective observational study. Can J Surg 2002; 45 (4) 264-268
• 8 Miller Jr JI, Landreneau RJ, Wright CE, Santucci TS, Sammons BH. A comparative study of buttressed versus nonbuttressed staple line in pulmonary resections. Ann Thorac Surg 2001; 71 (1) 319-322 , discussion 323
• 9 Brunelli A, Xiume F, Al Refai M, Salati M, Marasco R, Sabbatini A. Air leaks after lobectomy increase the risk of empyema but not of cardiopulmonary complications: a case-matched analysis. Chest 2006; 130 (4) 1150-1156
• 10 Stolz AJ, Schützner J, Lischke R, Simonek J, Pafko P. Predictors of prolonged air leak following pulmonary lobectomy. Eur J Cardiothorac Surg 2005; 27 (2) 334-336
• 11 Varela G, Jiménez MF, Novoa N, Aranda JL. Estimating hospital costs attributable to prolonged air leak in pulmonary lobectomy. Eur J Cardiothorac Surg 2005; 27 (2) 329-333
• 12 Murray KD, Ho CH, Hsia JY, Little AG. The influence of pulmonary staple line reinforcement on air leaks. Chest 2002; 122 (6) 2146-2149
• 13 Asamura H, Suzuki K, Kondo H, Tsuchiya R. Mechanical vascular division in lung resection. Eur J Cardiothorac Surg 2002; 21 (5) 879-882
• 14 Hazelrigg SR, Boley TM, Naunheim KS , et al. Effect of bovine pericardial strips on air leak after stapled pulmonary resection. Ann Thorac Surg 1997; 63 (6) 1573-1575
• 15 Stammberger U, Klepetko W, Stamatis G , et al. Buttressing the staple line in lung volume reduction surgery: a randomized three-center study. Ann Thorac Surg 2000; 70 (6) 1820-1825
• 16 Venuta F, Rendina EA, De Giacomo T , et al. Technique to reduce air leaks after pulmonary lobectomy. Eur J Cardiothorac Surg 1998; 13 (4) 361-364
• 17 Vaughn CC, Wolner E, Dahan M , et al. Prevention of air leaks after pulmonary wedge resection. Ann Thorac Surg 1997; 63 (3) 864-866
• 18 Saito T, Kaneda H, Konobu T, Saito Y. The covering with forceps-assisted polymeric biodegradable sheet and endostapling method: a simplified technique for wide coverage and reinforcement of staple-line in video-assisted thoracoscopic bullectomy for spontaneous pneumothorax. Interact Cardiovasc Thorac Surg 2011; 12 (2) 103-105
• 19 Yano T, Haro A, Shikada Y, Okamoto T, Maruyama R, Maehara Y. A unique method for repairing intraoperative pulmonary air leakage with both polyglycolic acid sheets and fibrin glue. World J Surg 2012; 36 (2) 463-467
• 20 Ishihara K, Hasegawa T, Okazaki M , et al. [OK432 chemical pleurodesis as a standard therapy of spontaneous pneumothorax]. Nihon Kyobu Shikkan Gakkai Zasshi 1988; 26 (1) 10-15
• 21 Yokomise H, Satoh K, Ohno N, Tamura K. Autoblood plus OK432 pleurodesis with open drainage for persistent air leak after lobectomy. Ann Thorac Surg 1998; 65 (2) 563-565
• 22 Fabian T, Federico JA, Ponn RB. Fibrin glue in pulmonary resection: a prospective, randomized, blinded study. Ann Thorac Surg 2003; 75 (5) 1587-1592
• 23 Wong K, Goldstraw P. Effect of fibrin glue in the reduction of postthoracotomy alveolar air leak. Ann Thorac Surg 1997; 64 (4) 979-981
• 24 Porte HL, Jany T, Akkad R , et al. Randomized controlled trial of a synthetic sealant for preventing alveolar air leaks after lobectomy. Ann Thorac Surg 2001; 71 (5) 1618-1622
• 25 Anegg U, Lindenmann J, Matzi V, Smolle J, Maier A, Smolle-Jüttner F. Efficiency of fleece-bound sealing (TachoSil) of air leaks in lung surgery: a prospective randomised trial. Eur J Cardiothorac Surg 2007; 31 (2) 198-202
• 26 Lang G, Csekeö A, Stamatis G , et al. Efficacy and safety of topical application of human fibrinogen/thrombin-coated collagen patch (TachoComb) for treatment of air leakage after standard lobectomy. Eur J Cardiothorac Surg 2004; 25 (2) 160-166
• 27 Balsara KR, Balderson SS, D'Amico TA. Surgical techniques to avoid parenchymal injury during lung resection (fissureless lobectomy). Thorac Surg Clin 2010; 20 (3) 365-369
• 28 Temes RT, Willms CD, Endara SA, Wernly JA. Fissureless lobectomy. Ann Thorac Surg 1998; 65 (1) 282-284
• 29 Belda-Sanchis J, Serra-Mitjans M, Iglesias Sentis M, Rami R. Surgical sealant for preventing air leaks after pulmonary resections in patients with lung cancer. Cochrane Database Syst Rev 2010; (1) CD003051
• 30 Malapert G, Hanna HA, Pages PB, Bernard A. Surgical sealant for the prevention of prolonged air leak after lung resection: meta-analysis. Ann Thorac Surg 2010; 90 (6) 1779-1785
• 31 Ayabe T, Shimizu T, Tomita M, Hara M, Onitsuka T. Bronchoscopic removal of staple-line reinforcement material. J Bronchology Interv Pulmonol 2011; 18 (3) 274-277
• 32 Downey DM, Harre JG, Pratt JW. Functional comparison of staple line reinforcements in lung resection. Ann Thorac Surg 2006; 82 (5) 1880-1883
• 33 Pugliese R, Maggioni D, Sansonna F , et al. Efficacy and effectiveness of suture bolster with Seamguard. Surg Endosc 2009; 23 (6) 1415-1416