机器人辅助与传统腹腔镜入路用于直肠癌手术：埃及首个学术中心的经验，随机对照试验

Robotic-Assisted versus Conventional Laparoscopic Approach for Rectal Cancer Surgery, First Egyptian Academic Center Experience, RCT.

作者信息

Debakey Yasser, Zaghloul Ashraf, Farag Ahmed, Mahmoud Ahmed, Elattar Inas

机构信息

Assistant Teacher of Surgical Oncology, National Cancer Institute, Cairo University, Egypt.

Head of Robotic Surgery Unit, National Cancer Institute, Cairo University, Egypt.

出版信息

Minim Invasive Surg. 2018 Sep 2;2018:5836562. doi: 10.1155/2018/5836562. eCollection 2018.

DOI:10.1155/2018/5836562

PMID:30245874

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6139204/

Abstract

BACKGROUND

Undoubtedly, robotic systems have largely penetrated the surgical field. For any new operative approach to become an accepted alternative to conventional methods, it must be proved safe and result in comparable outcomes. The purpose of this study is to compare the short-term operative as well as oncologic outcomes of robotic-assisted and laparoscopic rectal cancer resections.

METHODS

This is a prospective randomized clinical trial conducted on patients with rectal cancer undergoing either robotic-assisted or laparoscopic surgery from April 2015 till February 2017. Patients' demographics, operative parameters, and short-term clinical and oncological outcomes were analyzed.

RESULTS

Fifty-seven patients underwent permuted block randomization. Of these patients, 28 were assigned to undergo robotic-assisted rectal surgery and 29 to laparoscopic rectal surgery. After exclusion of 12 patients following randomization, 45 patients were included in the analysis. No significant differences exist between both groups in terms of age, gender, BMI, ASA score, clinical stage, and rate of receiving upfront chemoradiation. Estimated blood loss was evidently lower in the robotic than in the laparoscopic group (median: 200 versus 325 ml, p= 0.050). A significantly more distal margin is achieved in the robotic than in the laparoscopic group (median: 2.8 versus 1.8, p< 0.001). Although the circumferential radial margin (CRM) was complete in 18 patients (85.7%) in the robotic group in contrast to 15 patients (62.5%) in the laparoscopic group, it did not differ statistically (p=0.079). The overall postoperative complication rates were similar between the two groups.

CONCLUSION

To our knowledge, this is the first prospective randomized trial of robotic rectal surgery in the Middle East and Northern Africa region. Our early experience indicates that robotic rectal surgery is a feasible and safe procedure. It is not inferior to standard laparoscopy in terms of oncologic radicality and surgical complications. Organization number is IORG0003381. IRB number is IRB00004025.

摘要

背景

毫无疑问，机器人系统已在很大程度上渗透到外科手术领域。任何一种新的手术方法要成为传统方法可接受的替代方案，都必须证明其安全性并能产生可比的结果。本研究的目的是比较机器人辅助与腹腔镜直肠癌切除术的短期手术及肿瘤学结果。

方法

这是一项前瞻性随机临床试验，研究对象为2015年4月至2017年2月期间接受机器人辅助或腹腔镜手术的直肠癌患者。分析了患者的人口统计学特征、手术参数以及短期临床和肿瘤学结果。

结果

57例患者进行了区组随机化。其中，28例被分配接受机器人辅助直肠手术，29例接受腹腔镜直肠手术。随机分组后排除12例患者，45例患者纳入分析。两组在年龄、性别、体重指数、美国麻醉医师协会（ASA）评分、临床分期以及接受术前放化疗的比例方面无显著差异。机器人组的估计失血量明显低于腹腔镜组（中位数：200对325毫升，p = 0.050）。机器人组获得的远端切缘明显比腹腔镜组长（中位数：2.8对1.8，p < 0.001）。尽管机器人组18例患者（85.7%）的环周切缘（CRM）完整，而腹腔镜组为15例患者（62.5%），但差异无统计学意义（p = 0.079）。两组的总体术后并发症发生率相似。