Robotic vs Laparoscopic Surgery for Middle and Low Rectal Cancer: The REAL Randomized Clinical Trial.

Importance

Robotic surgery for rectal cancer is widely used, but data on long-term oncological outcomes are still lacking.

Objective

To compare the 3-year locoregional recurrence rates of middle and low rectal cancer in patients who underwent robotic surgery vs conventional laparoscopic surgery.

Design, setting, and participants

In this multicenter, superiority, randomized clinical trial, patients with middle or low rectal adenocarcinoma (cT1-T3, N0-N1, or ycT1-T3 Nx) and no distant metastasis were enrolled at 11 centers across 8 provinces in China from July 2016 to December 2020. Among the 1742 consecutive patients assessed for eligibility, 1240 were eligible and randomized. Follow-up continued until December 31, 2023.

Interventions

Patients were randomized 1:1 to undergo robotic or conventional laparoscopic rectal cancer resection.

Main outcomes and measures

The primary outcome was the 3-year locoregional recurrence rate. The primary analysis was performed as randomized, but excluded patients deemed ineligible after randomization. The secondary outcomes included disease-free survival; overall survival; and urinary, sexual, and defecation function.

Results

Of the 1240 patients enrolled, 1171 were included in the primary analysis (586 in the robotic surgery group; mean age, 59.1 [SD, 11.0] years; and 356 were men [60.8%] vs 585 in the laparoscopic surgery group; mean age, 60.7 [SD, 9.8] years; and 354 were men [60.5%]). The median follow-up time was 43.0 months (IQR, 36.7-60.0 months). The 3-year locoregional recurrence rate was 1.6% (95% CI, 0.6%-2.6%) in the robotic group vs 4.0% (95% CI, 2.4%-5.6%) in the laparoscopic group (hazard ratio [HR], 0.45 [95% CI, 0.22-0.92], log-rank P = .03; adjusted HR, 0.39 [95% CI, 0.19-0.80]). The 3-year disease-free survival rate was higher in the robotic group (87.2%) vs the laparoscopic group (83.4%) (HR, 0.74 [95% CI, 0.56-0.98], log-rank P = .04; adjusted HR, 0.67 [95% CI, 0.50-0.89]). No significant between-group difference was observed in 3-year overall survival (94.7% in the robotic group vs 93.0% in the laparoscopic group). Patients in the robotic group also had better urinary function, male and female sexual function, and defecation function at 3 and 6 months after surgery and better urinary function and male sexual function at 12 months after surgery.

Conclusions and relevance

Compared with conventional laparoscopic surgery, robotic surgery significantly improved long-term oncological outcomes in patients with middle or low rectal cancer. With additional real-world clinical data and modern, improved training programs for surgeons, robotic surgery could be the preferred choice for patients with middle or low rectal cancer.

Trial registration

ClinicalTrials.gov Identifier: NCT02817126.

CommentOn

JAMA. 2025 Jul 8;334(2):121-123. doi: 10.1001/jama.2025.7019.

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