Blanchard C, Pattou F, Brunaud L, Hamy A, Dahan M, Mathonnet M, Volteau C, Caillard C, Durand-Zaleski I, Mirallié E
Clinique de Chirurgie Digestive et Endocrinienne Centre Hospitalier Universitaire (CHU) de Nantes Nantes France.
Chirurgie Générale et Endocrinienne, CHU Lille Université de Lille Lille France.
BJS Open. 2017 May 9;1(1):2-10. doi: 10.1002/bjs5.2. eCollection 2017 Feb.
The benefits of single-use ultrasonic scissors in thyroid surgery are still debated. Although this device has been shown to reduce operating time compared with conventional haemostasis, its cost-effectiveness has never been demonstrated. The aim of this study was to evaluate the efficacy, cost-effectiveness and safety of ultrasonic scissors for total thyroidectomy.
This was a prospective, randomized, multicentre trial conducted at 13 hospital sites. The primary endpoint was the percentage of patients with hypocalcaemia (serum calcium level below 2 mmol/l) on day 2. Secondary endpoints included postoperative complications and costs, with calculation of incremental cost differences and cost-effectiveness ratios.
In total, 1329 patients who underwent total thyroidectomy were included in the analysis: 670 were randomized to treatment with ultrasonic scissors and 659 to conventional haemostasis. There was no difference between groups in the rate of complications, including hypocalcaemia on day 2 (197 per cent in ultrasonic scissors group versus 203 per cent in conventional haemostasis group; P = 0·743). Median operating times were significantly shorter with ultrasonic scissors (90 versus 100 min with conventional haemostasis; P < 0·001). Total mean(s.d.) direct costs at 6 months were €4311(1547) and €4011(1596) respectively (P < 0·001).
Ultrasonic scissors were no more clinically effective than conventional haemostasis, but use of these devices was more costly. Registration number: NCT01551914 (http://www.clinicaltrials.gov).
一次性使用超声刀在甲状腺手术中的益处仍存在争议。尽管与传统止血方法相比，该器械已被证明可缩短手术时间，但其成本效益从未得到证实。本研究的目的是评估超声刀在全甲状腺切除术中的有效性、成本效益和安全性。
这是一项在13个医院开展的前瞻性、随机、多中心试验。主要终点是术后第2天出现低钙血症（血清钙水平低于2 mmol/L）的患者百分比。次要终点包括术后并发症和成本，并计算增量成本差异和成本效益比。
共有1329例行全甲状腺切除术的患者纳入分析：670例随机接受超声刀治疗，659例接受传统止血治疗。两组并发症发生率无差异，包括术后第2天的低钙血症（超声刀组为19.7%，传统止血组为20.3%；P = 0.743）。超声刀组的中位手术时间明显更短（90分钟，传统止血组为100分钟；P < 0.001）。6个月时的总平均（标准差）直接成本分别为4311（1547）欧元和4011（1596）欧元（P < 0.001）。
超声刀在临床效果上并不优于传统止血方法，但使用这些器械成本更高。注册号：NCT01551914（http://www.clinicaltrials.gov）。
