机器人手术与腹腔镜手术治疗胃腺癌的多中心前瞻性对照研究

Multicenter Prospective Comparative Study of Robotic Versus Laparoscopic Gastrectomy for Gastric Adenocarcinoma.

作者信息

Kim Hyoung-Il, Han Sang-Uk, Yang Han-Kwang, Kim Young-Woo, Lee Hyuk-Joon, Ryu Keun Won, Park Joong-Min, An Ji Yeong, Kim Min-Chan, Park Sungsoo, Song Kyo Young, Oh Sung Jin, Kong Seong-Ho, Suh Byoung Jo, Yang Dae Hyun, Ha Tae Kyung, Kim Youn Nam, Hyung Woo Jin

机构信息

*Department of Surgery, Yonsei University College of Medicine, Seoul, Republic of Korea †Gastric Cancer Center, Yonsei Cancer Center, Seoul, Republic of Korea ‡Robot & MIS Center, Severance Hospital, Yonsei University Health System, Seoul, Republic of Korea §Department of Surgery, Ajou University College of Medicine, Seoul, Republic of Korea ¶Department of Surgery, Seoul National University College of Medicine, Seoul, Republic of Korea ||Center for Gastric Cancer, National Cancer Center, Seoul, Republic of Korea **Department of Surgery, Chung-Ang University College of Medicine, Seoul, Republic of Korea ††Department of Surgery, Dong-A University College of Medicine, Seoul, Republic of Korea ‡‡Department of Surgery, Korea University College of Medicine, Seoul, Republic of Korea §§Department of Surgery, The Catholic University of Korea, Seoul, Republic of Korea ¶¶Department of Surgery, Inje University College of Medicine, Seoul, Republic of Korea ||||Department of Surgery, Hallym University College of Medicine, Seoul, Republic of Korea ***Department of Surgery, Hanyang University College of Medicine, Seoul, Republic of Korea †††Department of Biostatistics, Yonsei University College of Medicine, Seoul, Republic of Korea.

出版信息

Ann Surg. 2016 Jan;263(1):103-9. doi: 10.1097/SLA.0000000000001249.

DOI:10.1097/SLA.0000000000001249

PMID:26020107

Abstract

OBJECTIVE

To compare short-term surgical outcomes including financial cost of robotic and laparoscopic gastrectomy.

BACKGROUND

Despite a lack of supporting evidence, robotic surgery has been increasingly adopted as a minimally invasive modality for the treatment of gastric cancer because of its assumed technical superiority over conventional laparoscopy.

METHODS

A prospective, multicenter comparative study was conducted. Patients were matched according to the surgeon, extent of gastric resection, and sex. The primary endpoint was morbidity and mortality. Outcomes were analyzed on an intention-to-treat and per-protocol basis.

RESULTS

A total of 434 patients were enrolled for treatment with either robotic (n = 223) or laparoscopic (n = 211) gastrectomy for intention-to-treat analysis, and a total of 370 patients (n = 185 per treatment) were compared in per-protocol analysis. Results were similar between both analyses. In per-protocol analysis, both groups showed similar overall complication rates (robotic = 11.9% vs laparoscopic = 10.3%) and major complication rates (robotic = 1.1% vs laparoscopic = 1.1%) with no operative mortality in either group. Patients treated with robotic surgery showed significantly longer operative time (robotic = 221 minutes vs laparoscopic = 178 minutes; P < 0.001) and significantly higher total costs (robotic = US$13,432 vs laparoscopic = US$8090; P < 0.001), compared with those who underwent laparoscopic gastrectomy. No significant differences between groups were noted in estimated blood loss, rates of open conversion, diet build-up, or length of hospital stay.

CONCLUSIONS

The use of robotic systems is assumed to provide a technically superior operative environment for minimally invasive surgery. However, our analysis of perioperative surgical outcomes indicated that robotic gastrectomy is not superior to laparoscopic gastrectomy. Clinical trials identification: NCT01309256.

摘要

目的

比较机器人辅助与腹腔镜胃切除术的短期手术结果，包括财务成本。

背景

尽管缺乏支持证据，但由于机器人手术被认为在技术上优于传统腹腔镜手术，它已越来越多地被用作治疗胃癌的微创方式。

方法

进行了一项前瞻性、多中心比较研究。根据外科医生、胃切除范围和性别对患者进行匹配。主要终点是发病率和死亡率。在意向性治疗和符合方案的基础上分析结果。

结果

共有434例患者接受机器人辅助（n = 223）或腹腔镜（n = 211）胃切除术进行意向性治疗分析，在符合方案分析中总共比较了370例患者（每组185例）。两种分析结果相似。在符合方案分析中，两组总体并发症发生率相似（机器人辅助组 = 11.9%，腹腔镜组 = 10.3%），主要并发症发生率相似（机器人辅助组 = 1.1%，腹腔镜组 = 1.1%），两组均无手术死亡。与接受腹腔镜胃切除术的患者相比，接受机器人手术的患者手术时间明显更长（机器人辅助组 = 221分钟，腹腔镜组 = 178分钟；P < 0.001），总成本明显更高（机器人辅助组 = 13,432美元，腹腔镜组 = 8090美元；P < 0.001）。两组在估计失血量、中转开腹率、饮食恢复或住院时间方面无显著差异。