Jiro Okami1, Toshiteru Tokunaga2, Takashi Kanou2, Hidenori Kunou2, Daisuke Ishida2, Ayako Fujiwara2, Yuri Ito3, Masahiko Higashiyama2. 1. Department of General Thoracic Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan. Electronic address: okami-ji@mc.pref.osaka.jp. 2. Department of General Thoracic Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan. 3. Center for Cancer Control and Statistics, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan.
Abstract
BACKGROUND: There are two forms of staple cartridge available for lung cancer operations, the flat face with equal height staples and the stepped face with graduated height staples. The objective of the study was to evaluate their stapling ability in lobectomy. METHODS: A randomized prospective study was conducted to compare two types of stapling reloads for bronchial closure. Stapling ability was evaluated by the staple formation on the resected bronchial stump. The stumps were sliced along the staple line, and the shapes of the staples were recorded by roentgenogram. Then, the staple formation was scored as 0 to 4 points with 4 approximating a perfect B-shaped staple. RESULTS: A total of 61 patients were randomly assigned to the equal height staples (n = 30) or the graduated height staples (n = 31). From 61 patients, 183 staple lines, which included 1,144 staples, were evaluated. The case scores were significantly lower in the equal height staples than in the graduated height staples (2.17 versus 2.88, p = 0.0003), respectively. The percentage of staples that formed a complete "B" shape was significantly higher in the graduated height staples than in the equal height staples (25.3% versus 10.0%, p = 0.000). No considerable difference was found between the two groups concerning postoperative complications. No bronchopleural fistula was observed. CONCLUSIONS: The graduated height staples had significantly higher scores of the staple formation on the bronchia stump than the equal height staples. From the clinical point of view, both the equal height staples and the graduated height staples showed acceptable performance in the stapling ability.
RCT Entities:
BACKGROUND: There are two forms of staple cartridge available for lung cancer operations, the flat face with equal height staples and the stepped face with graduated height staples. The objective of the study was to evaluate their stapling ability in lobectomy. METHODS: A randomized prospective study was conducted to compare two types of stapling reloads for bronchial closure. Stapling ability was evaluated by the staple formation on the resected bronchial stump. The stumps were sliced along the staple line, and the shapes of the staples were recorded by roentgenogram. Then, the staple formation was scored as 0 to 4 points with 4 approximating a perfect B-shaped staple. RESULTS: A total of 61 patients were randomly assigned to the equal height staples (n = 30) or the graduated height staples (n = 31). From 61 patients, 183 staple lines, which included 1,144 staples, were evaluated. The case scores were significantly lower in the equal height staples than in the graduated height staples (2.17 versus 2.88, p = 0.0003), respectively. The percentage of staples that formed a complete "B" shape was significantly higher in the graduated height staples than in the equal height staples (25.3% versus 10.0%, p = 0.000). No considerable difference was found between the two groups concerning postoperative complications. No bronchopleural fistula was observed. CONCLUSIONS: The graduated height staples had significantly higher scores of the staple formation on the bronchia stump than the equal height staples. From the clinical point of view, both the equal height staples and the graduated height staples showed acceptable performance in the stapling ability.
Authors: Matthew Eschbach; Gregory M Sindberg; Marisha L Godek; Matthew Nagelschmidt; Nicholas Paquette; Michael Wegener; James Alberino; Jane Mayotte; Amit Vasanji; Andrew M Miesse Journal: Med Devices (Auckl) Date: 2018-08-15