Chirurgia Generale, Policlinico Tor Vergata (PTV, p. 6B), University of Rome Tor Vergata, Viale Oxford 81, 00133, Rome, Italy.
Updates Surg. 2011 Dec;63(4):277-81. doi: 10.1007/s13304-011-0099-y. Epub 2011 Jul 26.
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.
本研究旨在比较使用 Harmonic Focus（HF）和传统“打结”（KT）进行全甲状腺切除术（TT）的手术时间、甲状旁腺功能和术后并发症的结果。本前瞻性研究采用随机分配的方法设计，采用抽签技术进行分组。2010 年，81 例连续患者接受 TT，并随机分为两组：43 例患者使用 HF 进行手术（HF 组），38 例患者使用 KT 进行手术（KT 组）。甲状旁腺功能通过术后 1 小时甲状旁腺激素（PTH）水平和第 1 天术后血钙水平来评估。药物治疗的指征是 PTH<15pg/ml 和/或血钙<8.0mg/dl 和/或有低钙血症的临床症状或体征。主要结果是手术时间、PTH 和钙水平、药物治疗的需要和术后并发症。HF 组的手术时间明显低于 KT 组（100±34 分钟对 119±30 分钟）。HF 组和 KT 组的暂时性甲状旁腺功能减退症需要补钙和/或维生素 D 治疗的患者比例分别为 17 例（39.5%）和 21 例（55.3%），无统计学差异。5 例（11.6%）HF 组患者出现症状性低钙血症，6 例（15.8%）KT 组患者出现症状性低钙血症，差异无统计学意义。无患者发生喉返神经损伤。HF 是一种新的符合人体工程学的、可靠的甲状腺手术器械。根据我们的结果，HF 是一种安全、节省时间的“打结”甲状腺切除术替代方法，对甲状旁腺功能、药物治疗和神经损伤没有影响。
