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
