Objective: The aim of this study was to investigate efficacy, safety, and ergonomic design of handle of the recently introduced multifunctional device (LigaSure AdvanceTM) that has sealing, dissection and division functions on live animals.
Materials and methods: Eight domestic pigs were included in the study designed to assess functionality, thermal spread and ergonomic evaluation of the instrument handle design. The study was performed on 8 pigs randomized to laparoscopic or open electrosurgery: dissection, coagulation, and division performed in following regions: biliary and porta hepatis, gasrtoesophageal junction, transverse colon, and renal pedicles and ureters. Endoscopic infrared camera was used to evaluate the thermal spread, and collateral damage. The number of activation times was recorded and expert opinions were obtained.
Results: Dissection, coagulation, and division of tissue and vessels were performed safely and effectively with the AdvanceTM, which was characterized by a bloodless surgical field, reduced number of instrument changes, and averaged thermal spread of 1.0 +/- 0.5 mm at peak temperature at 97.9+/- 10.9oC in 8 procedures. Fifty-six occasions (23%) required the assistant to activate the device by pressing various buttons on the top of the handle during two hundred and forty-two activations of the use of LigaSure AdvanceTM devices were recorded. Subjective evaluation from experts suggested that the handle design of the LigaSure AdvanceTM was not user friendly.
Conclusions: The newly introduced multifunctional LigaSure AdvanceTM device is a safe and effective multifunctional tool for dissection, hemostasis, vessel division and hollow organ transection with minimal thermal spread. However, the handle design of this smart device requires improvement.
Program Number: P234