Yasser Debakey, Ashraf Zaghloul, Ahmed Farag, Ahmed Mahmoud, Inas Elattar
{"title":"机器人辅助与传统腹腔镜方法在直肠癌手术中的比较,埃及第一学术中心经验,随机对照试验。","authors":"Yasser Debakey, Ashraf Zaghloul, Ahmed Farag, Ahmed Mahmoud, Inas Elattar","doi":"10.1155/2018/5836562","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":45110,"journal":{"name":"Minimally Invasive Surgery","volume":"2018 ","pages":"5836562"},"PeriodicalIF":1.3000,"publicationDate":"2018-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1155/2018/5836562","citationCount":"33","resultStr":"{\"title\":\"Robotic-Assisted versus Conventional Laparoscopic Approach for Rectal Cancer Surgery, First Egyptian Academic Center Experience, RCT.\",\"authors\":\"Yasser Debakey, Ashraf Zaghloul, Ahmed Farag, Ahmed Mahmoud, Inas Elattar\",\"doi\":\"10.1155/2018/5836562\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>\",\"PeriodicalId\":45110,\"journal\":{\"name\":\"Minimally Invasive Surgery\",\"volume\":\"2018 \",\"pages\":\"5836562\"},\"PeriodicalIF\":1.3000,\"publicationDate\":\"2018-09-02\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://sci-hub-pdf.com/10.1155/2018/5836562\",\"citationCount\":\"33\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Minimally Invasive Surgery\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1155/2018/5836562\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2018/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q3\",\"JCRName\":\"SURGERY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Minimally Invasive Surgery","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1155/2018/5836562","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2018/1/1 0:00:00","PubModel":"eCollection","JCR":"Q3","JCRName":"SURGERY","Score":null,"Total":0}
引用次数: 33
摘要
背景:毫无疑问,机器人系统已经在很大程度上渗透到外科领域。对于任何一种新的手术方法,要成为传统方法的一种可接受的替代方法,必须证明它是安全的,并产生可比较的结果。本研究的目的是比较机器人辅助和腹腔镜直肠癌切除术的短期手术效果和肿瘤预后。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。分析患者的人口统计学、手术参数、短期临床和肿瘤预后。结果:57例患者进行了分组随机化。在这些患者中,28人接受机器人辅助直肠手术,29人接受腹腔镜直肠手术。在随机化排除12例患者后,45例患者被纳入分析。两组患者在年龄、性别、BMI、ASA评分、临床分期、术前放化疗率等方面均无显著差异。机器人组的估计失血量明显低于腹腔镜组(中位数:200 ml vs 325 ml, p= 0.050)。机器人组的远端切缘明显高于腹腔镜组(中位数:2.8 vs 1.8, p< 0.001)。虽然机器人组有18例患者(85.7%)完成了圆周径向切缘(CRM),而腹腔镜组有15例患者(62.5%)完成了,但差异无统计学意义(p=0.079)。两组患者术后并发症发生率相似。结论:据我们所知,这是中东和北非地区第一个关于机器人直肠手术的前瞻性随机试验。我们的早期经验表明,机器人直肠手术是一种可行且安全的手术。在肿瘤根治性和手术并发症方面,它并不逊于标准腹腔镜。组织编号:IORG0003381。IRB号码为IRB00004025。
Robotic-Assisted versus Conventional Laparoscopic Approach for Rectal Cancer Surgery, First Egyptian Academic Center Experience, RCT.
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.