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A prospective, randomized controlled study of the safety and efficacy of gasless bilateral axillo-breast approach (BABA) robotic thyroidectomy.
Surgical Endoscopy ( IF 3.1 ) Pub Date : 2019-12-17 , DOI: 10.1007/s00464-019-07262-3
Ik Beom Shin 1 , Do Hoon Koo 1, 2 , Myoung Jin Ko 3 , Se Hoon Kim 3 , Dong Sik Bae 1, 2
Affiliation  

Background

During bilateral axillo-breast approach (BABA) robotic thyroidectomy (RoT), carbon dioxide (CO2) gas is insufflated into the operative cavity, not only triggering hemodynamic and metabolic changes, but also inducing postoperative pain and gas embolism. Here, we explored whether the new gasless BABA RoT approach was as safe and efficacious as conventional robotic surgery using CO2 insufflation.

Patients and methods

We performed a prospective, randomized controlled trial comparing conventional BABA RoT to gasless BABA RoT (CO2 group, n = 14; gasless group, n = 14). All clinicopathological and oncological outcomes were evaluated. The hemodynamic parameters [heart rate (HR), mean arterial pressure (MAP), cardiac output (CO), and cardiac index (CI)] and metabolic parameters [partial pressure of carbon dioxide (PaCO2) and pH] were measured at baseline; 30, 60, 90, and 120 min after CO2 insufflation; and 30 min after desufflation. Pain parameters [numeric rating scale (NRS) score, number of analgesics (NA), and bottom hit count (BHC)] were measured at 2, 24, 48, and 72 h after surgery.

Results

We found no statistically significant differences between the two groups in terms of any demographic or baseline characteristic. The clinicopathological and oncological outcomes did not differ significantly between the two groups, but the operation time was longer for the gasless group (187.50 ± 42.64 vs. 212.50 ± 35.88 min; P = 0.028). In terms of the hemodynamic, metabolic, and pain parameters, the pH fell significantly less in the gasless group (P = 0.047), but there were no significant between-group differences in the HR, MAP, CO, CI, PaCO2, NRS, NA, or BHC. No safety concerns arose.

Conclusion

The new, gasless BABA RoT technique employing the da Vinci robotic surgical system is safe. Although metabolic changes during operation are thereby minimized, gasless BABA RoT should be used carefully when engaging in thyroid surgery; more experience is required.



中文翻译:

前瞻性,随机对照研究对无气双侧腋窝乳房切除术(BABA)机器人甲状腺切除术的安全性和有效性进行的研究。

背景

在双侧腋窝-乳房手术(BABA)机器人甲状腺切除术(RoT)中,二氧化碳(CO 2)气体被注入手术腔中,不仅触发血液动力学和代谢变化,还引起术后疼痛和气体栓塞。在这里,我们探讨了新的无气BABA RoT方法是否与使用CO 2吹入的常规机器人手术一样安全有效。

患者和方法

我们进行了一项前瞻性,随机对照试验,比较了常规BABA RoT和无气BABA RoT(CO 2组,n  = 14;无气组,n  = 14)。评估所有临床病理和肿瘤学结局。在基线时测量血液动力学参数[心率(HR),平均动脉压(MAP),心输出量(CO)和心脏指数(CI)]和代谢参数[二氧化碳分压(PaCO 2)和pH] ; 注入CO 2后30、60、90和120分钟;排气后30分钟。在手术后第2、24、48和72小时测量疼痛参数[数字评分量表(NRS)评分,止痛药数量(NA)和最低击中次数(BHC)]。

结果

我们发现两组在任何人口统计学或基线特征方面均无统计学上的显着差异。两组之间的临床病理和肿瘤结局无显着差异,但无气组的手术时间更长(187.50±42.64 vs. 212.50±35.88 min;P  = 0.028)。就血液动力学,代谢和疼痛参数而言,无气组的pH下降明显较少(P  = 0.047),但HR,MAP,CO,CI,PaCO 2, NRS的组间差异无统计学意义,NA或BHC。没有引起安全隐患。

结论

采用达芬奇机器人手术系统的新型无气BABA RoT技术是安全的。尽管由此可将手术过程中的代谢变化减至最小,但在进行甲状腺手术时应谨慎使用无气的BABA RoT。需要更多经验。

更新日期:2019-12-17
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