Results of Li-Tho trial: a prospective randomized study on effectiveness of LigaSure® in lung resections.

OBJECTIVE

The role of electro-thermal bipolar tissue sealing system (LigaSure(®), (LS); Covidien, Inc., CO, USA) in thoracic surgery is still undefined. Reports of its use are still limited. The objective of the trial was to evaluate the cost and benefits of LS in major lung resection surgery.

METHODS

A randomized blinded study of a consecutive series of 100 patients undergoing lobectomy was undertaken. After muscle-sparing thoracotomy and classification of lung fissures according to Craig-Walker, patients with fissure Grade 2-4 were randomized to Stapler group or LS group fissure completion. Recorded parameters were analysed for differences in selected intraoperative and postoperative outcomes. Statistical analysis was performed with the bootstrap method. Pearson's χ(2) test and Fisher's exact test were used to calculate probability value for dichotomous variables comparison. Cost-benefit evaluation was performed using Pareto optimal analysis.

RESULTS

There were no significant differences between groups, regarding demographic and baseline characteristics. No patient was withdrawn from the study; no adverse effect was recorded. There was no mortality or major complications in both groups. There were no statistically significant differences as to operative time or morbidity between patients in the LS group compared with the Stapler group. In the LS group, there was a not statistically significant increase of postoperative air leaks in the first 24 postoperative hours, while a statistically significant increase of drainage amount was observed in the LS group. No statistically significant difference in hospital length of stay was observed. Overall, the LS group had a favourable multi-criteria analysis of cost/benefit ratio with a good 'Pareto optimum'.

CONCLUSIONS

LS is a safe device for thoracic surgery and can be a valid alternative to Staplers. In this setting, LS allows functional lung tissue preservation. As to costs, LS seems equivalent to Staplers.