Olijnyk José Gustavo, Ferreira Paulo Walter, Nácul Miguel Prestes, Cavazzola Leandro Totti
Department of Surgery, Post Graduation Program in Surgical Sciences, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil; Department of Education and Research (IEP), Hospital Moinhos de Vento, Porto Alegre, RS, Brazil.
Engineering Division, Nacional Service of Industrial Learning, (SENAI-RS), Porto Alegre, RS, Brazil.
J Minim Access Surg. 2016 Apr-Jun;12(2):129-34. doi: 10.4103/0972-9941.158951.
With the cooperation of surgeons and the engineering division of the company Bhio supply(©) (Esteio-RS, Brazil), a permanent single port was developed.
An experimental study assessed the safety and efficacy of the device using a swine laparoscopic appendectomy model (right salpingo-oophorectomy).
Experimental randomised study.
A total of 20 pigs were randomised for the conventional laparoscopic (CL) three-trocar technique or the single Centry port (CPort) with two working channels, aided by a transparietal thread. Operative times, surgical complications, CO2 use, and pneumoperitoneal pressure were checked. Pressure and chromopertubation tests assessed the ligatures.
For quantitative outcomes, the Fisher's exact test analysed the samples to compare the surgeons in each group, the ANOVA test for parametric data (volume and pressure) and the Student's t-test for analysis of the fascial incision length. The binaries and isolated occurrence events were described in percentages.
For all cases, pneumoperitoneum was maintained. The CPort group, however, resulted in higher CO2 use (26.18 l; standard deviation [SD] ± 11.09) than CL group (5.69 l; SD ± 2.44) (P < 0.01). The mean pressure in CPort group (6.604 mmHg, SD ± 1.793) was comparatively lower than in CL group (7.382 mmHg, SD ± 1.833) (P = 0.363). There was no statistical difference between operative times, ligature safety or adverse surgical events between the different groups and surgeons.
The surgical technique used with the single port showed no differences in safety and efficacy. Though it does require more CO2 use, its working dynamics did not lead to increased operative times. The results were similar between the two surgeons in the study, suggesting that they can be reproduced.
在外科医生与巴西Bhio supply公司(位于南里奥格兰德州埃斯泰约)的工程部门合作下,研发出了一种永久性单孔装置。
一项实验研究使用猪腹腔镜阑尾切除术模型(右侧输卵管卵巢切除术)评估了该装置的安全性和有效性。
实验性随机研究。
总共20头猪被随机分配接受传统腹腔镜三孔技术或带有两个工作通道的单孔Centry端口(CPort),并借助经腹壁缝线辅助。检查手术时间、手术并发症、二氧化碳使用量和气腹压力。通过压力和染色输卵管通畅试验评估结扎情况。
对于定量结果,采用Fisher精确检验分析样本以比较每组中的外科医生,采用方差分析检验参数数据(体积和压力),采用学生t检验分析筋膜切口长度。二元和孤立发生事件以百分比描述。
所有病例均维持气腹状态。然而,CPort组的二氧化碳使用量(26.18升;标准差[SD]±11.09)高于传统腹腔镜组(CL组,5.69升;SD±2.44)(P<0.01)。CPort组的平均压力(6.604 mmHg,SD±1.793)相对低于CL组(7.382 mmHg,SD±1.833)(P = 0.363)。不同组和外科医生之间在手术时间、结扎安全性或不良手术事件方面无统计学差异。
使用单孔的手术技术在安全性和有效性方面无差异。尽管确实需要更多的二氧化碳使用量,但其工作动态并未导致手术时间增加。研究中的两位外科医生得到的结果相似,表明这些结果可以重现。