RESUMEN
BACKGROUND: Hemostasis is fundamental in thyroid surgery. The aim of this randomized active comparator-controlled study was to compare the effectiveness of LigasureTM Exact to previously existing sealing devices in patients undergoing thyroidectomy. METHODS: A total of 180 patients were randomly allocated into 4 groups according to the hemostatic device used: Focus Harmonic Scalpel® (FHS), LigasureTM Small Jaw (LSJ), Thunderbeat® (TB), and LigasureTM Exact (LE). We recorded epidemiologic and biochemical data, operative difficulty, postoperative vocal alteration and pain, complications, operating time, grams of gland excised per minute, and hospitalization. RESULTS: Differences (P<0.001) were observed concerning duration of surgery, operative difficulty and quantity of gland removed per minute. Concerning duration of surgery it is shorter for LE followed by TB and then by both FHS and LSJ. Concerning the quantity of thyroid removed per minute LE leads, followed by FHS and TB. The least amount of gland removed per minute is by LSJ. Finally, operative difficulty was less for LE, while it was equal for all other three devices. CONCLUSIONS: Energy devices are now frequently used in thyroidectomy. Comparing these devices seems to qualify them as equal concerning post-operative complications, hemostasis, and acute inflammatory reaction. However, LigasureTM Exact Dissector seems to have better results concerning duration of surgery, quantity of thyroid tissue removed per minute and intraoperative difficulty.
RESUMEN
OBJECTIVE: Postoperative hypoparathyroidism (hypoPT) still remains a significant complication after thyroidectomy. Intra-operative imaging modalities, such as near-infrared fluorescence using indocyanine green (ICG), may assist in identifying and preserving the parathyroid glands (PGs). The purpose of this study was to test the association between the intra-operative ICG staining scoring system and 24-hour postoperative parathyroid hormone (PTH) levels, as well as its capability for intra-operative PG identification. METHODS: This was a prospective study, recruiting patients scheduled for total thyroidectomy by the same surgical team, from December 2018 to April 2019. Intra-operative angiography was performed after infusion of ICG solution (5 mg). Two minutes later, images were acquired using the near-infrared system. RESULTS: Sixty patients fulfilled the eligibility criteria. The percentage of temporary postoperative hypoPT (defined as PTH <14 pg/mL) was 11.66%. No association between intra-operative ICG staining score (expressed as the number of PGs scoring <2 per patient) and 24-hour postoperative PTH (r = 0.011; P = .933) or serum calcium concentrations (r = 0.127; P = .335) was observed. There was also no correlation between the location of PGs scoring ≤2 and postoperative PTH (P = .257) or serum calcium levels (P = .950). Moreover, with regard to secondary endpoint, ICG correctly identified PGs in 98.3% of cases. ICG score was not affected by age, gender, duration of operation, or thyroid gland pathology. No allergic reactions attributed to ICG administration were observed. CONCLUSION: The intra-operative ICG staining scoring system did not predict 24-hour postoperative PTH and serum calcium levels. However, this modality may assist in intra-operative PG identification during a total thyroidectomy.