Lebanon, N.H. From the Division of Plastic and Reconstructive Surgery and the Leadership Preventive Medicine Residency Program, Dartmouth-Hitchcock Medical Center.
Plast Reconstr Surg. 2011 Oct;128(4):243e-249e. doi: 10.1097/PRS.0b013e318221da3e.
The authors hypothesized that the Harmonic Scalpel (Ethicon Endo-Surgery, Cincinnati, Ohio) might outperform electrocautery in bilateral breast reduction surgery, possibly resulting in (1) shorter operative times, (2) lower postoperative fluid drainage rates, and (3) reduced postoperative pain scores.
Thirty-one patients were evaluated in a matched-pair design, with random (blinded) assignment of one side to the Harmonic Scalpel, with the other side defaulting to electrocautery. Main outcome measures were: (1) resection/hemostasis time, (2) drainage volume, and (3) postoperative pain. The authors also compared the learning curves, operative time versus specimen weights, complications, and costs for the devices.
There was a statistically significant (but not clinically significant) difference between the median times for the Harmonic Scalpel (33 minutes) and electrocautery (31 minutes) (p=0.02). There was no statistical difference in drainage scores, and pain scores were equivalent. The analysis of specimen weight versus resection/hemostasis time showed no correlation. There were more complications on the breasts reduced with the Harmonic device, but due to the small sample size, the complication results were not statistically significant. Start-up costs for the devices were comparable, but the per-procedure cost for the Harmonic device was considerably higher.
The Harmonic Scalpel is roughly equivalent to electrocautery in breast reduction surgery in terms of resection/hemostasis time, serous drainage, and postoperative pain. Though the Harmonic device may be excellent for other surgical procedures, its high cost suggests that surgeons and institutions can confidently forgo its use in breast reduction surgery.
CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.
作者假设 Harmonic Scalpel（Ethicon Endo-Surgery，Cincinnati，Ohio）在双侧乳房缩小手术中可能优于电烙术，可能导致（1）手术时间更短，（2）术后液体引流率更低，以及（3）术后疼痛评分降低。
采用配对设计评估了 31 例患者，随机（盲法）将一侧分配给 Harmonic Scalpel，另一侧默认使用电烙术。主要观察指标为：（1）切除/止血时间，（2）引流量，（3）术后疼痛。作者还比较了学习曲线、手术时间与标本重量、并发症和设备成本。
Harmonic Scalpel（中位数 33 分钟）和电烙术（中位数 31 分钟）的中位时间之间存在统计学上的显著差异（但无临床意义）（p=0.02）。引流评分无统计学差异，疼痛评分相当。标本重量与切除/止血时间的分析显示无相关性。使用 Harmonic 设备缩小的乳房并发症更多，但由于样本量小，并发症结果无统计学意义。设备的启动成本相当，但 Harmonic 设备的每例手术成本要高得多。
在切除/止血时间、浆液性引流和术后疼痛方面，Harmonic Scalpel 在乳房缩小手术中与电烙术大致相当。尽管 Harmonic 设备可能非常适合其他手术，但它的高成本表明，外科医生和医疗机构可以有信心在乳房缩小手术中放弃使用它。
临床问题/证据水平：治疗性，II 级。
