Department of General and Emergency Surgery, Vittorio Veneto Hospital, Vittorio Veneto (Treviso), Italy.
General Surgery, ASST Spedali Civili Di Brescia PO Montichiari, Brescia, Montichiari, Italy.
Langenbecks Arch Surg. 2024 Jul 17;409(1):217. doi: 10.1007/s00423-024-03399-5.
We conducted a systematic review and meta-analysis to evaluate the role of High Energy Devices (HEDs) versus conventional clamp and tie technique in thyroidectomy. This work is endorsed by the Italian Society of Surgical Endoscopy (Italian Society of Endoscopic Surgery and new technologies-SICE) in the broader project on the evaluation of the role of HEDs in different surgical settings with the full health technology assessment report.
Inclusion criteria were adult patients (≥ 18 years old) undergoing Thyroidectomy/Parathyroidectomy conducted with High Energy Devices (as ultrasonic (US), radiofrequency (RF), and hybrid energy (H-US/RF)) in the setting of thyroid surgery (both partial and total) for benign and malign diseases. However, some variability was found in included studies and described in the text. This systematic review and meta-analysis were performed according to the Cochrane handbook for systematic reviews, and the recommendations of the 2020 updated Preferred Reporting Items for Systematic reviews and Meta-analyses (PRISMA) guidelines were pursuit. Selection of abstracts was performed in Ryyan system by 2 independent reviewers, and doubts were solved by another independent reviewer. At the end of literature research, Randomized controlled trials and observational studies were included. Risk of Bias was assessed with ROB2 for RCTs, and New Castle Ottawa Scale for Observational studies.
The literature search yielded 47 studies, including 29 RCTs and 18 observational studies. Meta-analysis was performed for 29 randomized clinical trials. Outcomes included in the comparison between High Energy Devise and conventional technique groups were operative time, operative blood loss, overall post-operative drainage volume, length of stay, complications, and costs. HED significantly reduced operative time (28 studies, 3097patients; MD -128.8; 95% CI -34.4 to -23.20; I2 = 96%, p < 0.00001, Random-effect), intra-operative blood loss (13 studies, 642 vs 519 patients; SMD -0.82; 95% CI -1.33 to -0.32; I2 = 93%, p < 0.00001, Random-effect), LOS (22 studies, 2808 vs 2789 patients; MD -0.38, 95% CI -0.59 to -0.17; I2 = 98%, p < 0.00001 Random-effect), and healthcare costs (8 studies, 1138 vs 1129 patients, SMD 1.05; 95% CI -0.06 to 2.16; I2 = 99%, p < 0.00001 Random-effect). The rate of overall intraoperative complications was significantly different between both groups (25 studies, 2804 vs 2775 patients; RR 0.88, 95% CI 0.80 to 0.97; I2 = 38%, p = 0.03 Random-effect), but the sensitivity analysis did not find a statistically significant difference (6 studies, 605 vs 594 patients, RR; 95% CI to; I2 = 0%, p = 0.50, Random-effect). There was no difference in the subgroup analysis for the occurrence of transient and permanent RLN palsy, nor hematoma formation and hypocalcaemia.
Though findings of our systematic review and metanalysis are limited by heterogeneous data, surgeons, hospital managers, and policymakers should note that the use of High Energy Devices compared to conventional clamp and tie technique have reduced operative times, intra-operative blood loss, length of stay, and hospital costs in patients underwent to tyroid surgery. Future work must explore issues of equity to mitigate barriers to patient access to safe thyroid surgical care and define better this initial results.
我们进行了一项系统评价和荟萃分析，以评估高能设备（HEDs）与传统夹闭和结扎技术在甲状腺切除术中的作用。这项工作得到了意大利外科内镜学会（意大利内镜外科学和新技术学会-SICE）的支持，该学会在更广泛的项目中评估了 HED 在不同手术环境中的作用，该项目包括完整的卫生技术评估报告。
纳入标准为接受甲状腺切除术/甲状旁腺切除术的成年患者（≥18 岁），手术中使用高能设备（超声（US）、射频（RF）和混合能量（H-US/RF）），手术范围包括良性和恶性疾病的甲状腺手术（部分和全部）。然而，纳入的研究存在一些差异，并在文本中进行了描述。这项系统评价和荟萃分析是根据 Cochrane 系统评价手册进行的，并且遵循了 2020 年更新的系统评价和荟萃分析（PRISMA）建议报告规范。通过 Ryyan 系统由 2 名独立评审员对摘要进行选择，对存在疑问的摘要由另一名独立评审员解决。在文献研究结束时，纳入了随机对照试验和观察性研究。使用 ROB2 评估 RCT 的偏倚风险，使用纽卡斯尔渥太华量表评估观察性研究的偏倚风险。
文献检索共得到 47 项研究，包括 29 项 RCT 和 18 项观察性研究。对 29 项随机临床试验进行了荟萃分析。比较高能设备组和传统技术组的结果包括手术时间、术中出血量、总术后引流体积、住院时间、并发症和成本。HED 显著缩短了手术时间（28 项研究，3097 例患者；MD-128.8；95%CI-34.4 至-23.20；I²=96%，p<0.00001，随机效应）、术中出血量（13 项研究，642 例与 519 例患者；SMD-0.82；95%CI-1.33 至-0.32；I²=93%，p<0.00001，随机效应）、住院时间（22 项研究，2808 例与 2789 例患者；MD-0.38；95%CI-0.59 至-0.17；I²=98%，p<0.00001，随机效应）和医疗保健成本（8 项研究，1138 例与 1129 例患者，SMD 1.05；95%CI-0.06 至 2.16；I²=99%，p<0.00001，随机效应）。两组之间总体术中并发症发生率存在显著差异（25 项研究，2804 例与 2775 例患者；RR 0.88；95%CI 0.80 至 0.97；I²=38%，p=0.03，随机效应），但敏感性分析未发现统计学差异（6 项研究，605 例与 594 例患者，RR；95%CI；I²=0%，p=0.50，随机效应）。亚组分析未发现暂时性和永久性 RLN 麻痹、血肿形成和低钙血症的发生率存在差异。
尽管我们的系统评价和荟萃分析的结果受到异质性数据的限制，但外科医生、医院管理人员和政策制定者应该注意到，与传统的夹闭和结扎技术相比，高能设备在甲状腺手术患者中缩短了手术时间、术中出血量、住院时间和住院费用。未来的研究必须探讨公平问题，以减轻患者获得安全甲状腺手术护理的障碍，并更好地确定这些初步结果。
