June 17, 2025 — The Journal of the American Medical Association (JAMA) has officially published the results of the REAL trial (Robotic vs. Laparoscopic Surgery for Middle and Low Rectal Cancer), a landmark randomized controlled study led by Zhongshan Hospital, Fudan University. This large-scale, multicenter trial provides the most robust evidence to date supporting the oncologic and functional benefits of robotic surgery in rectal cancer.
Conducted across 11 high-volume colorectal cancer centers in eight provinces in China, the REAL trial enrolled 1,240 patients with clinically staged cT1–T3, N0–N1, or post-neoadjuvant ycT1–T3Nx mid and low rectal adenocarcinoma (defined as tumors ≤10 cm from the anal verge), all without distant metastases. Patients were randomized 1:1 to undergo either robotic or conventional laparoscopic radical rectal resection and followed for three years. All participating surgeons underwent rigorous credentialing to ensure standardized surgical quality across centers.
The trial demonstrated a significant reduction in the 3-year locoregional recurrence rate for the robotic group (1.6%) compared to the laparoscopic group (4.0%) (HR=0.45, 95% CI: 0.22–0.92, P=0.03). Disease-free survival was also significantly higher in the robotic group (87.2% vs. 83.4%; HR=0.74, P=0.04), though overall survival was similar between groups (94.7% vs. 93.0%, P=0.16).
Beyond oncologic endpoints, the REAL study also reported better postoperative functional outcomes for patients undergoing robotic surgery. At 3, 6, and 12 months postoperatively, robotic patients showed significantly better urinary function (IPSS scores, P<0.001), superior sexual function scores (IIEF-5 for males, FSFI for females), and improved defecation control during early recovery (Wexner scores, P<0.01). These findings underscore the robotic platform’s capacity not only for surgical precision but also for enhancing postoperative quality of life.
The REAL trial is the first randomized controlled trial to clearly demonstrate that robotic surgery is superior to laparoscopic surgery in terms of local control and disease-free survival. It also shows advantages in functional recovery, providing strong support for improving patients’ postoperative quality of life. The researchers attributed these benefits to the robotic system’s precise maneuverability within the narrow pelvic cavity—particularly during total mesorectal excision for low-lying tumors—allowing for more thorough tumor removal and better preservation of nerve function. The accompanying editorial in JAMA, authored by Drs. Min Jung Kim and J. Joshua Smith from Memorial Sloan Kettering Cancer Center, characterized the REAL trial as a pivotal transition from oncologic equivalence to superiority for robotic surgery in rectal cancer. They noted that, in contrast to prior trials such as ROLARR and COLRAR, the REAL study achieved methodological excellence with adequate sample size, strict endpoint design, and credentialed high-volume surgeons, making it the most robust evidence to date supporting robotic TME.
However, the editorial also cautioned against overgeneralizing the results. The benefits observed in high-volume, well-resourced centers with credentialed surgeons may not extend to low-volume or resource-limited settings. Widespread implementation of robotic rectal surgery will require robust training programs, quality assurance systems, and thoughtful policy planning—especially considering the high acquisition and maintenance costs of robotic platforms. Further real-world studies and health economic evaluations will be essential to assess cost-effectiveness and scalability across diverse healthcare systems.
