机器人辅助与腹腔镜手术治疗直肠癌的比较：一项 II 期开放标签前瞻性随机对照试验。

Robot-assisted Versus Laparoscopic Surgery for Rectal Cancer: A Phase II Open Label Prospective Randomized Controlled Trial.

机构信息

Center for Colorectal Cancer, Research Institute and Hospital, National Cancer Center, Goyang, Republic of Korea.

Department of Surgery, Seoul National University College of Medicine, Seoul, Republic of Korea.

出版信息

Ann Surg. 2018 Feb;267(2):243-251. doi: 10.1097/SLA.0000000000002321.

DOI:10.1097/SLA.0000000000002321

PMID:28549014

Abstract

OBJECTIVE

The phase II randomized controlled trial aimed to compare the outcomes of robot-assisted surgery with those of laparoscopic surgery in the patients with rectal cancer.

BACKGROUND

The feasibility of robot-assisted surgery over laparoscopic surgery for rectal cancer has not been established yet.

METHODS

Between February 21, 2012 and March 11, 2015, patients with rectal cancer (cT1-3NxM0) were enrolled. Patients were randomized 1:1 to either robot-assisted or laparoscopic surgery, and stratified per sex and administration of preoperative chemoradiotherapy. The primary outcome was the quality of total mesorectal excision (TME) specimen. Secondary outcomes were the circumferential and distal resection margins, the number of harvested lymph nodes, morbidity, bowel function recovery, and quality of life.

RESULTS

A total of 163 patients were randomly assigned to the robot-assisted (n = 81) and laparoscopic (n = 82) surgery groups, and 139 patients were eligible for the analyses (73 vs 66, respectively). One patient (1.2%) in the robot-assisted group was converted to open surgery. The TME quality did not differ between the robot-assisted and laparoscopic groups (80.3% vs 78.1% complete TME, respectively; 18.2% vs 21.9% nearly complete TME, respectively; P = 0.599). The resection margins, number of harvested lymph nodes, morbidity, and bowel function recovery also were not significantly different. On analyzing quality of life, scores of the European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ C30) and EORTC QLQ CR38 were similar in the 2 groups, but in the EORTC QLQ CR 38 questionnaire, sexual function 12 months postoperatively was better in the robot-assisted group than in the laparoscopic group (P = 0.03).

CONCLUSIONS

Robot-assisted surgery in rectal cancer showed TME quality comparable with that of laparoscopic surgery, and it demonstrated similar postoperative morbidity, bowel function recovery, and quality of life.

摘要

目的

这项 II 期随机对照试验旨在比较机器人辅助手术与腹腔镜手术治疗直肠癌患者的疗效。

背景

机器人辅助手术治疗直肠癌的可行性尚未得到证实。

方法

2012 年 2 月 21 日至 2015 年 3 月 11 日期间，纳入直肠癌（cT1-3NxM0）患者。患者按 1:1 随机分配至机器人辅助手术组或腹腔镜手术组，并按性别和术前放化疗进行分层。主要结局为全直肠系膜切除（TME）标本的质量。次要结局为环周和远端切缘、淋巴结清扫数目、发病率、肠道功能恢复和生活质量。

结果

共 163 例患者被随机分配至机器人辅助手术组（n = 81）和腹腔镜手术组（n = 82），139 例患者符合分析条件（分别为 73 例和 66 例）。机器人辅助手术组有 1 例（1.2%）患者中转开腹手术。机器人辅助手术组与腹腔镜手术组的 TME 质量无差异（完全 TME 分别为 80.3%和 78.1%；近乎完全 TME 分别为 18.2%和 21.9%；P = 0.599）。切缘、淋巴结清扫数目、发病率和肠道功能恢复也无显著差异。在分析生活质量时，两组欧洲癌症研究与治疗组织生活质量问卷（EORTC QLQ C30）和 EORTC QLQ CR38 评分相似，但在 EORTC QLQ CR 38 问卷中，机器人辅助组患者术后 12 个月的性功能优于腹腔镜组（P = 0.03）。