Department of General Surgery.
Department of General Surgery, Zhongshan Hospital (Xiamen Branch), Fudan University, Xiamen, People's Republic of China.
Int J Surg. 2023 Nov 1;109(11):3346-3353. doi: 10.1097/JS9.0000000000000581.
This study aimed to compare the short-term and long-term outcomes between robotic-assisted simultaneous resection and open surgery in patients with rectal cancer and liver metastases.
Open simultaneous resection of colorectal cancer and synchronous liver metastases is widely performed and the potential cure for eligible patients. However, the feasibility of robotic simultaneous resection of primary and secondary liver lesions has not been established as a treatment option for metastatic rectal cancer.
A single-center randomized controlled trial was conducted at a hospital in China. Enrolling patients were aged from 18 to 75 years and diagnosed with surgically resectable metastatic rectal cancer (distal extension to ≤15 cm from the anal margin). Patients selected for simultaneous resection were randomly assigned to have robotic or open surgery at a 1:1 ratio. The primary endpoint was the incidence rate of complications within 30 days after surgery. Secondary endpoints were bladder, sexual function, 3-year disease-free survival, and overall survival.
A total of 171 patients were enrolled in this trial with 86 in the robotic group and 85 in the open group. As a result, patients in the robotic group demonstrated fewer complications within 30 days after surgery than those in the open group (31.4 vs. 57.6%, P =0.014) and no mortality seen in either group. Patients in the robotic group had less blood loss [mean (SD), 125.5 (38.3) vs. 211.6 (68.7) ml; P <0.001], faster bowel function recovery [mean (SD), 63.7 (27.4) vs. 93.8 (33.5) h P <0.001] and shorter hospital stay [mean (SD), 8.0 (2.2) vs. 10.7 (5.4) days; P <0.001] compared with those in the open group. The robotic group had a faster recovery of bladder and sexual function at 3 months after surgery than that of the open group. The 3-year disease-free survival rate (39.5 vs. 35.3%, P =0.739) and the 3-year overall survival rate (76.7 vs. 72.9%, P =0.712) were not statistically significant between the two groups.
In our randomized clinical trial, robotic simultaneous resection treatment of patients with rectal cancer and liver metastases resulted in fewer surgical complications, and a faster recovery to those of open surgery. Oncological outcomes showed no significant difference between the two groups.
本研究旨在比较机器人辅助同期直肠切除术与开放性手术治疗直肠癌伴肝转移患者的短期和长期疗效。
开放性同期结直肠癌和同步肝转移切除术被广泛应用,为符合条件的患者提供了潜在治愈的机会。然而,机器人辅助同期原发性和继发性肝病变切除术的可行性尚未确立为转移性直肠癌的治疗选择。
这是在中国的一家医院进行的单中心随机对照试验。纳入的患者年龄为 18 至 75 岁,诊断为可手术切除的转移性直肠癌(远端延伸至肛门边缘<15cm)。选择同期切除的患者以 1:1 的比例随机分配至机器人或开放性手术组。主要终点为术后 30 天内并发症的发生率。次要终点为膀胱功能、性功能、3 年无病生存率和总生存率。
本试验共纳入 171 例患者,其中机器人组 86 例,开放性组 85 例。结果显示,机器人组术后 30 天内并发症发生率低于开放性组(31.4%比 57.6%,P=0.014),两组均无死亡病例。机器人组术中出血量更少[平均(标准差),125.5(38.3)比 211.6(68.7)ml;P<0.001],肠道功能恢复更快[平均(标准差),63.7(27.4)比 93.8(33.5)h;P<0.001],住院时间更短[平均(标准差),8.0(2.2)比 10.7(5.4)天;P<0.001]。与开放性组相比,机器人组术后 3 个月膀胱和性功能恢复更快。两组 3 年无病生存率(39.5%比 35.3%,P=0.739)和 3 年总生存率(76.7%比 72.9%,P=0.712)无统计学差异。
在我们的随机临床试验中,机器人辅助同期直肠切除术治疗直肠癌伴肝转移患者的手术并发症更少,恢复速度更快。两组患者的肿瘤学结局无显著差异。