Robotic versus laparoscopic surgery for middle and low rectal cancer (REAL): Short-term outcomes of a multicenter randomized controlled trial.

Authors

Jianmin Xu

Jianmin Xu

Department of General Surgery, Zhongshan Hospital Fudan University, Shanghai, China

Jianmin Xu , Weitang Yuan , Taiyuan Li , Bo Tang , Baoqing Jia , Yanbing Zhou , Wei Zhang , Ren Zhao , Cheng Zhang , Longwei Cheng , Xiaoqiao Zhang , Fei Liang , Guodong He , Ye Wei , Qingyang Feng

Organizations

Department of General Surgery, Zhongshan Hospital Fudan University, Shanghai, China, Department of Colorectal Surgery, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, China, Department of General Surgery, the First Affiliated Hospital of Nanchang University, Nanchang, China, Department of General Surgery, Southwest Hospital, Army medical University, Chongqing, China, Department of General Surgery, The First Medical Center, PLA General Hospital, Beijing, China, Department of Gastrointestinal Surgery, the Affiliated Hospital of Qingdao University, Qingdao, China, Department of Colorectal Surgery, Changhai Hospital, Navy Medical University, Shanghai, China, Department of General Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China, Department of General Surgery, Northern Theater Command General Hospital, Shenyang, China, Second Department of Gastrointestinal Surgery, Jilin Cancer Hospital, Changchun, China, Department of General Surgery, Shandong Provincial Hospital affiliated to the Shandong First Medical University, Jinan, China, Department of Biostatistics, Zhongshan Hospital Fudan University, Shanghai, China, Department of Colorectal Surgery, Zhongshan Hospital Fudan University, Shanghai, China

Research Funding

Other

Background: Robotic surgery for rectal cancer is gaining popularity, but persuasive evidence on long-term oncological outcomes is lacking. This multicenter randomized controlled trial compared robotic and conventional laparoscopic surgery regarding surgical quality and long-term oncological outcomes among patients with middle and low rectal cancer. Methods: This superiority trial was undertaken at 11 hospitals in 8 Chinese provinces. Patients with middle (> 7–12 cm from anal verge) or low (0–7 cm from anal verge) rectal adenocarcinoma, cT1–T3 N0–1 or ycT1–T3 Nx after preoperative radio-/chemoradiotherapy, and no evidence of distant metastasis were enrolled and randomly assigned in a 1:1 ratio to receive robotic or conventional laparoscopic surgery. Secondary (short-term) end points (surgical quality, pathological radicality, and postoperative recovery) were compared using modified intention-to-treat (mITT) analysis. Three-year locoregional recurrence rate as the primary endpoint is expected by the end of 2023. This trial was registered with ClinicalTrials.gov (NCT02817126). Results: Between July 2016 and December 2020, 1240 patients were enrolled; 1180 were included in the mITT analysis (591 in robotic and 589 in laparoscopic group). There were significantly more sphincter-preserving surgeries (low anterior resections) performed in the robotic group (83.1% vs. 76.9%, p = 0.008). With more macroscopic complete resections (95.4% vs. 91.9%, p = 0.012), robotic surgery had better integrity of the mesorectal fascia, and had lower circumferential resection margin positivity rate (4.0% vs. 7.1%, difference = -3.1%, 95% confidence interval = -6.0% to -0.5%, p = 0.023) and more lymph nodes harvested (median, 15.0 vs. 14.0, p = 0.004). Robotic surgery also reduced the open conversion rate (1.7% vs. 3.9%, p = 0.021), estimated blood loss (median, 40.0 ml vs. 50.0 ml, p < 0.001), intraoperative complication rate (5.4% vs. 8.7%, p = 0.029), and 30-day postoperative complication rate (Clavien-Dindo grade II or higher, 16.1% vs. 22.9%, p = 0.003), leading to better postoperative recovery and shorter postoperative hospital stay (median, 7.0 days vs. 8.0 days, p < 0.001). The 30-day postoperative mortality was similar between the two groups (0.2% vs. 0.2%, p > 0.999). Conclusions: Robotic surgery for middle and low rectal cancer significantly reduced surgical injury, improved oncological radicality, and promoted postoperative recovery compared with conventional laparoscopic surgery. Clinical trial information: NCT02817126.

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Abstract Details

Meeting

2022 ASCO Gastrointestinal Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session C: Cancers of the Colon, Rectum, and Anus

Track

Colorectal Cancer,Anal Cancer

Sub Track

Therapeutics

Clinical Trial Registration Number

NCT02817126

DOI

10.1200/JCO.2022.40.4_suppl.014

Abstract #

14

Poster Bd #

Online Only

Abstract Disclosures

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