LigaSure vs clamp-and-tie technique to achieve hemostasis in total thyroidectomy for benign multinodular goiter: a prospective randomized study.

HYPOTHESIS: Occurrence of adverse effects and advantages of the LigaSure diathermy system (or LigaSure vessel sealing system) in total thyroidectomy have not been tested in prospective randomized studies comparing its use with that of the time-saving clamp-and-tie technique to ligate and divide thyroid vessels. The effectiveness of LigaSure in achieving vessel division and hemostasis remains dependent on vessel diameter, and the risk of damage to adjacent structures cannot be completely excluded. We tested the hypothesis that use of LigaSure compared with the clamp-and-tie technique can significantly and conveniently reduce operative time without increasing postoperative complications in patients undergoing total thyroidectomy for benign multinodular goiter.
DESIGN: Prospective randomized study.
SETTING: Regional hospital. PATIENTS: Two hundred consecutive patients with benign multinodular goiter undergoing total thyroidectomy performed by 1 of 3 surgeons.
INTERVENTIONS: According to a randomized sequence, total thyroidectomy was performed in 100 patients using LigaSure and in 100 patients using the clamp-and-tie technique. MAIN OUTCOME MEASURES: End points of the study included the comparative evaluation of postoperative complications, need for parathyroid gland autotransplantation, operative time, and time to hospital discharge. Preoperative, postoperative (24 hours), and 6-week follow-up serum Ca(++) levels are also reported and compared.
RESULTS: The postoperative complication rate was 35% overall, including all transient postoperative disturbances. The incidence of cervical hematomas was 2%, but 3 patients (1.5%), 1 in the LigaSure group and 2 in the clamp-and-tie group, required repeat operations because of respiratory tract obstruction. The incidence of permanent complications was 2.5% overall, including 3 patients (1.5%) with permanent hypocalcemia and 2 patients (1%) with permanent recurrent nerve lesions. No statistical difference in the incidence of complications was found between the 2 study groups. Similarly, no difference was found in mean hospitalization time and need for parathyroid gland autotransplantation. Preoperative, postoperative, and 6-week follow-up mean serum Ca(++) levels were not statistically different in the 2 study groups and in the subset of patients undergoing parathyroid gland autotransplantation. Mean operative time was significantly shorter in the LigaSure group, although the mean difference between the 2 study groups was minimal (7.4 minutes). Concomitantly, there was an additional cost of 45euro (US $57.40) per operation using LigaSure.
CONCLUSION: The use of LigaSure is equally as safe and effective at vessel division and homeostasis as the clamp-and-tie technique, with a statistically significant (although minimal) decrease in mean operative time. Because of this minimal decrease in operative time, use of LigaSure would allow more patients to undergo total thyroidectomy each year, which would eventually help to offset its higher cost.

RCT Entities:   Population Interventions Outcomes