title: Harmonic Focus™ versus "knot tying" during total thyroidectomy: a randomized trial.
abstract: The objective of the study is to compare the outcome of total thyroidectomy (TT) using the Harmonic Focus™ (HF) versus conventional "knot tying" (KT) in terms of operative time, parathyroid function and post-operative complications. This prospective study was designed with a random allocation of subjects using a drawing technique. Eighty-one consecutive patients were submitted to TT in 2010 and randomly divided into two groups: 43 patients operated using HF (HF group) and 38 patients operated using KT (KT group). Parathyroid function was evaluated by parathyroid hormone (PTH) level at 1 h postoperatively and calcium level at first post-operative day. Indications for medical therapy were PTH < 15 pg/ml and/or calcium < 8.0 mg/dl and/or clinical signs or symptoms of hypocalcemia. Main outcomes were operative time, PTH and calcium levels, need for medical therapy and post-operative complications. Mean operative time was significantly lower in HF group compared with KT group (100 ± 34 vs. 119 ± 30 min). There were no significant differences concerning transient hypoparathyroidism requiring calcium and/or vitamin D therapy: 17 patients (39.5%) in HF group versus 21 (55.3%) in KT group. Five patients (11.6%) in HF group experienced symptomatic hypocalcemia versus 6 (15.8%) in KT group, without statistically significant difference. No patients experienced recurrent nerve injury. HF is a new ergonomic, reliable device developed for thyroid surgery. According to our results, HF is a safe, time-saving alternative to "knot tying" thyroidectomy, with no influence on parathyroid function, medical therapy and nerve injury.
authors.affiliation: Chirurgia Generale, Policlinico Tor Vergata (PTV, p. 6B), University of Rome Tor Vergata, Viale Oxford 81, 00133, Rome, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Gentileschi
authors.forename: Stefano
authors.initials: S
authors.lastname: D'Ugo
authors.forename: Edoardo
authors.initials: E
authors.lastname: Iaculli
authors.forename: Achille Lucio
authors.initials: AL
authors.lastname: Gaspari
mesh_terms: D002118:Calcium / Q000097:blood; D005260:Female; D006801:Humans; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D010281:Parathyroid Hormone / Q000097:blood; D011183:Postoperative Complications; D011184:Postoperative Period; D011446:Prospective Studies; D013536:Suture Techniques; D013965:Thyroidectomy / Q000295:instrumentation* / Q000379:methods*; D013997:Time Factors; D014464:Ultrasonic Therapy / Q000295:instrumentation*
chemical_list: D010281:Parathyroid Hormone; D002118:Calcium