Effect of Robotic-Assisted vs Conventional Laparoscopic Surgery on Risk of Conversion to Open Laparotomy Among Patients Undergoing Resection for Rectal Cancer,JAMA

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Effect of Robotic-Assisted vs Conventional Laparoscopic Surgery on Risk of Conversion to Open Laparotomy Among Patients Undergoing Resection for Rectal Cancer
JAMA ( IF 63.1 ) Pub Date : 2017-10-24 , DOI: 10.1001/jama.2017.7219
David Jayne ₁ , Alessio Pigazzi ₂ , Helen Marshall ₃ , Julie Croft ₃ , Neil Corrigan ₃ , Joanne Copeland ₃ , Phil Quirke ₄ , Nick West ₄ , Tero Rautio ₅ , Niels Thomassen ₆ , Henry Tilney ₇ , Mark Gudgeon ₇ , Paolo Pietro Bianchi ₈ , Richard Edlin ₉ , Claire Hulme ₁₀ , Julia Brown ₃

Affiliation

Importance Robotic rectal cancer surgery is gaining popularity, but limited data are available regarding safety and efficacy. Objective To compare robotic-assisted vs conventional laparoscopic surgery for risk of conversion to open laparotomy among patients undergoing resection for rectal cancer. Design, Setting, and Participants Randomized clinical trial comparing robotic-assisted vs conventional laparoscopic surgery among 471 patients with rectal adenocarcinoma suitable for curative resection conducted at 29 sites across 10 countries, including 40 surgeons. Recruitment of patients was from January 7, 2011, to September 30, 2014, follow-up was conducted at 30 days and 6 months, and final follow-up was on June 16, 2015. Interventions Patients were randomized to robotic-assisted (n = 237) or conventional (n = 234) laparoscopic rectal cancer resection, performed by either high (upper rectum) or low (total rectum) anterior resection or abdominoperineal resection (rectum and perineum). Main Outcomes and Measures The primary outcome was conversion to open laparotomy. Secondary end points included intraoperative and postoperative complications, circumferential resection margin positivity (CRM+) and other pathological outcomes, quality of life (36-Item Short Form Survey and 20-item Multidimensional Fatigue Inventory), bladder and sexual dysfunction (International Prostate Symptom Score, International Index of Erectile Function, and Female Sexual Function Index), and oncological outcomes. Results Among 471 randomized patients (mean [SD] age, 64.9 [11.0] years; 320 [67.9%] men), 466 (98.9%) completed the study. The overall rate of conversion to open laparotomy was 10.1%: 19 of 236 patients (8.1%) in the robotic-assisted laparoscopic group and 28 of 230 patients (12.2%) in the conventional laparoscopic group (unadjusted risk difference = 4.1% [95% CI, −1.4% to 9.6%]; adjusted odds ratio = 0.61 [95% CI, 0.31 to 1.21]; P = .16). The overall CRM+ rate was 5.7%; CRM+ occurred in 14 (6.3%) of 224 patients in the conventional laparoscopic group and 12 (5.1%) of 235 patients in the robotic-assisted laparoscopic group (unadjusted risk difference = 1.1% [95% CI, −3.1% to 5.4%]; adjusted odds ratio = 0.78 [95% CI, 0.35 to 1.76]; P = .56). Of the other 8 reported prespecified secondary end points, including intraoperative complications, postoperative complications, plane of surgery, 30-day mortality, bladder dysfunction, and sexual dysfunction, none showed a statistically significant difference between groups. Conclusions and Relevance Among patients with rectal adenocarcinoma suitable for curative resection, robotic-assisted laparoscopic surgery, as compared with conventional laparoscopic surgery, did not significantly reduce the risk of conversion to open laparotomy. These findings suggest that robotic-assisted laparoscopic surgery, when performed by surgeons with varying experience with robotic surgery, does not confer an advantage in rectal cancer resection. Trial Registration isrctn.org Identifier: ISRCTN80500123

中文翻译：

机器人辅助与传统腹腔镜手术对接受直肠癌切除术的患者转为开腹手术风险的影响

重要性机器人直肠癌手术越来越受欢迎，但关于安全性和有效性的数据有限。目的比较机器人辅助与传统腹腔镜手术在接受直肠癌切除术的患者中转开腹的风险。设计、设置和参与者比较机器人辅助与传统腹腔镜手术的随机临床试验在 10 个国家的 29 个地点（包括 40 名外科医生）对 471 名适合根治性切除的直肠腺癌患者进行。患者入组时间为2011年1月7日至2014年9月30日，随访30天6个月，末次随访时间为2015年6月16日。干预患者被随机分为机器人辅助 (n = 237) 或常规 (n = 234) 腹腔镜直肠癌切除术，通过高位（上直肠）或低位（全直肠）前路切除术或腹会阴切除术（直肠和会阴）进行。主要结果和措施主要结果是转为开腹手术。次要终点包括术中和术后并发症、环切缘阳性 (CRM+) 和其他病理结果、生活质量（36 项简表调查和 20 项多维疲劳量表）、膀胱和性功能障碍（国际前列腺症状评分、勃起功能国际指数和女性性功能指数）和肿瘤学结果。结果在 471 名随机患者中（平均 [SD] 年龄，64.9 [11.0] 岁；320 [67. 9%] 男性），466 人（98.9%）完成了研究。开腹手术的总中转率为 10.1%：机器人辅助腹腔镜组 236 名患者中有 19 名（8.1%），传统腹腔镜组 230 名患者中有 28 名（12.2%）（未经调整的风险差异 = 4.1% [95 % CI，-1.4% 至 9.6%]；调整优势比 = 0.61 [95% CI，0.31 至 1.21]；P = .16）。整体 CRM+ 率为 5.7%；传统腹腔镜组 224 名患者中有 14 名（6.3%）和机器人辅助腹腔镜组 235 名患者中有 12 名（5.1%）发生 CRM+（未调整的风险差异 = 1.1% [95% CI，-3.1% 至 5.4%） ]；调整后的优势比 = 0.78 [95% CI，0.35 至 1.76]；P = .56）。在其他 8 个报告的预设次要终点中，包括术中并发症、术后并发症、手术平面、30 天死亡率、膀胱功能障碍、和性功能障碍，没有一个显示出组间的统计学显着差异。结论和相关性在适合根治性切除的直肠腺癌患者中，机器人辅助腹腔镜手术与传统腹腔镜手术相比，并未显着降低中转开腹手术的风险。这些发现表明，机器人辅助腹腔镜手术，当由具有不同机器人手术经验的外科医生进行时，在直肠癌切除术中并没有优势。试用注册 isrctn.org 标识符：ISRCTN80500123 与传统腹腔镜手术相比，并未显着降低中转开腹手术的风险。这些发现表明，机器人辅助腹腔镜手术，当由具有不同机器人手术经验的外科医生进行时，在直肠癌切除术中并没有优势。试用注册 isrctn.org 标识符：ISRCTN80500123 与传统腹腔镜手术相比，并未显着降低中转开腹手术的风险。这些发现表明，机器人辅助腹腔镜手术，当由具有不同机器人手术经验的外科医生进行时，在直肠癌切除术中并没有优势。试用注册 isrctn.org 标识符：ISRCTN80500123

更新日期：2017-10-24

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