REAL (3-year follow-up)
Trial question
Is robotic surgery superior to laparoscopic surgery in patients with middle and low rectal cancer?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
39.0% female
61.0% male
N = 1171
1171 patients (461 female, 710 male).
Inclusion criteria: patients with middle or low rectal adenocarcinoma with no evidence of distant metastasis.
Key exclusion criteria: cT1N0 tumors suitable for local excision; clinical complete response after preoperative chemoradiotherapy; need for emergency surgery.
Interventions
N=586 robotic surgery (robot-assisted resection using da Vinci® system).
N=585 laparoscopic surgery (traditional laparoscopic resection).
Primary outcome
Locoregional recurrence rate at 3 years
1.6%
4%
4.0 %
3.0 %
2.0 %
1.0 %
0.0 %
Robotic
surgery
Laparoscopic
surgery
Significant
decrease ▼
NNT = 41
Significant decrease in locoregional recurrence rate at 3 years (1.6% vs. 4%; HR 0.45, 95% CI 0.22 to 0.92).
Secondary outcomes
Significant increase in disease-free survival rate at 3 years (87.2% vs. 83.4%; HR 1.35, 95% CI 1.02 to 1.79).
No significant difference in overall survival at 3 years (94.7% vs. 93%; HR 1.33, 95% CI 0.89 to 2).
Significant decrease in median IPSS at 12 months (4 points vs. 5 points; AD -1 points, 95% CI -1.59 to -0.41).
Conclusion
In patients with middle or low rectal adenocarcinoma with no evidence of distant metastasis, robotic surgery was superior to laparoscopic surgery with respect to locoregional recurrence rate at 3 years.
Reference
Qingyang Feng, Weitang Yuan, Taiyuan Li et al. Robotic vs Laparoscopic Surgery for Middle and Low Rectal Cancer: The REAL Randomized Clinical Trial. JAMA. 2025 Jun 2. Online ahead of print.
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