OBJECTIVES:Vessel-sealing devices (VSDs) are widely used for various surgical procedures, including thoracoscopic surgery, but very few reports have compared their safety and usefulness with human thoracoscopic lobectomy procedures not employing VSDs. METHODS:Primary lung cancer patients for whom a thoracoscopic lobectomy involving mediastinal lymph node dissection was planned in our department from April 2011 to March 2013 were recruited for the study. Patients were randomly allocated to a control group (n = 14) or a VSD group (n = 44), which comprised three sub-groups, namely EnSeal (n = 17), LigaSure (n = 15) and Harmonic (n = 12). The control group comprised patients undergoing surgery solely with ligation and conventional electrocautery. EnSeal, LigaSure and Harmonic were chosen because they are the three most popular disposable VSDs used in Japan. In the VSD groups, the proximal side of pulmonary artery stumps (≤7 mm diameter) were ligated and then treated with respective devices. Primary end-points were burst pressure of the pulmonary artery stump (measured using resected specimens), operative time, intraoperative blood loss, instances of endostapler use, intraoperative surgeon stress (assessed by visual analogue scale) and postoperative drainage volume and duration. As a secondary objective, the individual VSD groups were also compared with each other. RESULTS: The burst pressure of ligation-treated pulmonary artery stumps was higher than that of VSD-treated stumps (P <0.0001). The burst pressure of <5-mm-wide VSD-treated stumps was higher than that of ≥5-mm-wide stumps (P = 0.0421). However, the burst pressure for all groups and all vessel diameters was sufficient to withstand the physiological pulmonary artery pressure. The VSD group demonstrated reduced intraoperative blood loss (P = 0.0241), surgeon stress (P = 0.0002), postoperative drainage volume (P = 0.0358) and shortened postoperative drainage duration (P = 0.0449). Operative time and the instances of endostapler use did not significantly differ. Comparison between each of the VSD groups revealed no significant differences. None of the patients experienced serious perioperative complications or died because of surgery. CONCLUSION:VSD is simple and safe to use in thoracoscopic lobectomy involving mediastinal lymph node dissection for primary lung cancer. Furthermore, none of the VSDs used in this study presented any observable differences in quality that could lead to clinical problems.
RCT Entities:
OBJECTIVES: Vessel-sealing devices (VSDs) are widely used for various surgical procedures, including thoracoscopic surgery, but very few reports have compared their safety and usefulness with human thoracoscopic lobectomy procedures not employing VSDs. METHODS:Primary lung cancerpatients for whom a thoracoscopic lobectomy involving mediastinal lymph node dissection was planned in our department from April 2011 to March 2013 were recruited for the study. Patients were randomly allocated to a control group (n = 14) or a VSD group (n = 44), which comprised three sub-groups, namely EnSeal (n = 17), LigaSure (n = 15) and Harmonic (n = 12). The control group comprised patients undergoing surgery solely with ligation and conventional electrocautery. EnSeal, LigaSure and Harmonic were chosen because they are the three most popular disposable VSDs used in Japan. In the VSD groups, the proximal side of pulmonary artery stumps (≤7 mm diameter) were ligated and then treated with respective devices. Primary end-points were burst pressure of the pulmonary artery stump (measured using resected specimens), operative time, intraoperative blood loss, instances of endostapler use, intraoperative surgeon stress (assessed by visual analogue scale) and postoperative drainage volume and duration. As a secondary objective, the individual VSD groups were also compared with each other. RESULTS: The burst pressure of ligation-treated pulmonary artery stumps was higher than that of VSD-treated stumps (P <0.0001). The burst pressure of <5-mm-wide VSD-treated stumps was higher than that of ≥5-mm-wide stumps (P = 0.0421). However, the burst pressure for all groups and all vessel diameters was sufficient to withstand the physiological pulmonary artery pressure. The VSD group demonstrated reduced intraoperative blood loss (P = 0.0241), surgeon stress (P = 0.0002), postoperative drainage volume (P = 0.0358) and shortened postoperative drainage duration (P = 0.0449). Operative time and the instances of endostapler use did not significantly differ. Comparison between each of the VSD groups revealed no significant differences. None of the patients experienced serious perioperative complications or died because of surgery. CONCLUSION: VSD is simple and safe to use in thoracoscopic lobectomy involving mediastinal lymph node dissection for primary lung cancer. Furthermore, none of the VSDs used in this study presented any observable differences in quality that could lead to clinical problems.