”The use the Harmonic Scalpel versus conventional knot tyng for thyroidectomy: results of a case-control study”

Background: The Harmonic Scalpel (HS) coagulates and simultaneously cuts tissues using mechanical energy with ultrasonic frequency. Its role in minimally invasive thyroid surgery is well defined. Despite its routine use has been criticized by some, HS has been recently proposed also for conventional thyroidectomy (CT) in small series of patients. The aim of this comparative study is to verify in a large series of patients the efficiency and safety of HS for CT. Patients and methods: Between April 2004 and April 2005, 267 consecutive patients were prospectively selected to undergo total thyroidectomy (TT) with the use of HS (HS-Group). Exclusion criteria were: previous neck surgery, minimally invasive and/or video-assisted procedures, lymph node dissection or other associated procedures. A case-control study including 267 patients who underwent TT with a conventional haemostasis technique (knot tying) (KT-group) between January 2003 and March 2004 was performed. The controls were matched for age and sex. The following parameters were registered: preoperative diagnosis, operative time (from incision to skin closure), total operative room occupation time (from induction to the end of the anaesthesia), number of drains, total drainage fluid volume, complications, final histology, postoperative stay, postoperative pain, patients satisfaction with the cosmetic result and postoperative outcome. Patients of the HS-Group were compared with those of the KT-Group. Results: The two groups were well matched for age and sex (P = NS). No significant difference was found concerning preoperative diagnosis, final histology, postoperative pain, postoperative stay and complications rate (P = NS). One postoperative bleeding requiring reoperation was observed in the HS-Group; no other bleeding episodes were observed. Three transient recurrent nerve palsies were observed in each group, no permanent palsy was observed. Transient hypocalcemia was observed in 95 patients in HS-Group and in 94 in KT-Group; one patients in the KT-Group experienced permanent hypoparathyroidism (P = NS). Operative time was significantly shorter in the HS-Group (66.4 ± 17.3 vs 72.3 ± 23.6 minutes, P < 0.005), as well as the total operative room occupation time (95.0 ± 22.9 vs 103.9 ± 24.8 minutes, P < 0.001). The mean number of drains was significantly lower in the HS-Group (1.0 ± 0.4 vs 1.3 ± 0.5 minutes, P < 0.001). No significant difference was found 265 UNCORRECTED PROOF concerning drainage fluid volume in patients with drains. Patients of the HS-Group were more satisfied with the cosmetic result and the postoperative outcome (P < 0.001 and P < 0.005). Conclusion: HS is a safe and efficacious alternative to KT also for CT, allowing for a significant reduction of operative time (about 10 %) and drain utilization without increasing the complication rate. The higher patients satisfaction with the cosmetic result and the postoperative outcome could be explained by the possibility HS offers to perform TT through smaller skin incisions.