Robotic Surgery’s Advantage in Middle and Lower Rectal Cancer: Is the Chinese Trial Enough?

Implications for Clinical Practice, Strengths and Weaknesses in Light of the REAL Trial

Cancer of the rectum (the final part of the large intestine) accounts for approximately a quarter of colorectal cancers. Surgery—removing the tumor-bearing area—is one of its most important treatments. In recent years, laparoscopic surgery using smaller incisions instead of open surgery has become widespread. Patients generally experience less pain and recover faster with this method. Despite these advantages, however, questions remained about whether laparoscopy could completely remove the cancer.

Two concepts are particularly important here:

• CRM (Circumferential Resection Margin): The healthy tissue margin surrounding the tumor. If cancer cells remain at this margin, the tumor has not been completely removed and the risk of recurrence increases.
• TME (Total Mesorectal Excision): Removal of the fatty tissue and lymph nodes surrounding the rectum as a single unit. Performing this procedure completely is critical for controlling the disease.

This is where a new generation of laparoscopic surgery comes into play: robotic surgery . Robot-assisted surgery gives the surgeon a clearer view and enables more precise movements in narrow, delicate spaces. Until now, however, it was unclear whether these technical advantages improved long-term cancer recurrence or the course of the disease.

Conducted to answer this question, the REAL trialis a high-quality study with a large number of participants, examining both short-term recovery and 3-year cancer recurrence rates. It is therefore particularly important for understanding whether robotic surgery truly makes a difference.

Main Findings

• Patient group: 1240 patients with middle or lower rectal adenocarcinoma, stage cT1-3 N0-1 M0 or ycT1-3 Nx (11 centers, China)

• Differences observed:

  • 3-year local recurrence rate:

    • Robotic: 1.6%

    • Laparoscopic: 4.0%

    • HR: 0.45 [95% CI, 0.22-0.92], P = .03

  • 3-year disease-free survival (DFS):

    • Robotic: 87.2%

    • Laparoscopic: 83.4%

    • HR: 0.74 [95% CI, 0.56-0.98], P = .04

  • 3-year overall survival (OS):

    • Robotic: 94.7% vs Laparoscopic: 93.0% (no statistically significant difference)

• Functional benefit: The robotic group had better urinary, sexual and bowel function scores (Wexner, IPSS, IIEF, FSFI) during the first 6-12 months.

📊 Strengths of This Trial

1. High-quality design: Stands out for its randomized, controlled, multicenter design and adequate sample size.

2. Long-term oncological data: The first demonstration of a significant local recurrence benefit from robotic surgery in rectal cancer surgery.

3. Functional gains: Better preservation of pelvic nerves led to better preservation of urinary and sexual function.

4. Greater benefit in the lower rectum: Although a difference was seen across all patients, the DFS difference was greater in the lower rectum (86.2% vs 77.6%).

⚠️ What Are the Limitations?

1. Immunotherapy excluded: Modern neoadjuvant treatment strategies (immunotherapy in MMR-d cases) were not included in this trial.

2. Surgeon effect: All surgeons were experienced and proficient with the robotic system. Real-world practice may not reach this level.

3. Ethnic/genetic differences: All patients were Chinese. Generalizability to Western populations should be questioned.

4. Heterogeneous postoperative treatment: Adjuvant chemotherapy/radiotherapy was selected by each center rather than dictated by the protocol.

5. Follow-up may be insufficient for an OS difference: No difference in 3-year OS, but the literature suggests differences may emerge after 5+ years.

🌐 Comparison With the Literature

Will It Change Clinical Practice?

Potentially YES, in the following situations:

• Tumors located in the lower rectum

• Cases at risk of CRM involvement

• Young patients and those prioritizing functional preservation

However:

• It is difficult for this to become the preferred option at many centers until equipment access, affordability and surgeon training become widespread.

• Real-world data and cost-effectiveness analyses are needed.

🔐 Conclusion

REAL is the first randomized trial to demonstrate that robotic surgery for middle and lower rectal cancer may be superior to laparoscopy not only technically, but also oncologically and functionally in a phase 3 setting. Although it has the potential to transform clinical practice, careful assessment of generalizability and longer follow-up are essential before implementation.