REAL
Robotic vs Laparoscopic Surgery for Middle and Low Rectal Cancer: The REAL Randomized Clinical Trial
N = 1,240NCT02817126
- Population
- Patients with middle or low rectal adenocarcinoma (cT1-T3, N0-N1, or ycT1-T3 Nx) and no distant metastasis
- Design
- Multicentre, superiority randomised clinical trial at 11 centres in eight provinces of China (July 2016 to December 2020; follow-up to 31 December 2023). 1742 consecutive patients were assessed and 1240 eligible patients with middle or low rectal adenocarcinoma (cT1-T3, N0-N1, or ycT1-T3 Nx) and no distant metastasis were randomised 1:1 to robotic or conventional laparoscopic resection. Primary outcome 3-year locoregional recurrence; the primary analysis was as randomised but excluded patients deemed ineligible after randomisation. Investigators and patients were not masked; pathological outcomes were assessed masked to allocation.
- Primary endpoint
- Locoregional recurrence after rectal surgery
- Arms
- Conventional laparoscopic surgery (control, n = 620): Conventional laparoscopic rectal cancer resection
- Robotic surgery (experimental, n = 620): Robotic rectal cancer resection
- People
- Feng Q, REAL Study Group
Locoregional recurrence after rectal surgeryHR 0.45 (95% CI 0.22–0.92)Δ 36-month Locoregional recurrence after rectal surgery−2.4 pointsDFSHR 0.74 (95% CI 0.56–0.98)Δ 36-month DFS+3.8 pointsΔ 36-month OS+1.7 pointsΔ Positive circumferential resection margin−3.2 points
Show the numbers
| Endpoint | Analysis | Robotic surgery | Conventional laparoscopic surgery | Effect |
|---|---|---|---|---|
| Locoregional recurrence after rectal surgeryPrimary analysis population: 1171 patients (586 robotic, 585 laparoscopic), analysed as randomised after excluding patients deemed ineligible after randomisation3-year locoregional recurrence rate (primary outcome) | primarymedian follow-up 43 monthsFeng 2025 | 1.6% at 3 y (0.6–2.6%) | 4% at 3 y (2.4–5.6%) | HR 0.45 (95% CI 0.22–0.92)P=0.03Hazard ratio 0.45 with log-rank P = .03; the full text calls robotic surgery a protective factor in the adjusted analyses, which fixes the direction as robotic relative to laparoscopic. The full text states that the total of 35 primary-outcome events fell short of the 81 planned and that the research committee decided to analyse the primary outcome regardless (9 robotic and 23 laparoscopic events). Adjusted hazard ratio 0.39 (95% CI 0.19 to 0.80). Median follow-up 43.0 months (IQR 36.7 to 60.0). |
| DFSPrimary analysis population: 1171 patients (586 robotic, 585 laparoscopic)3-year disease-free survival (secondary outcome) | primarymedian follow-up 43 monthsFeng 2025 | 87.2% at 3 y | 83.4% at 3 y | HR 0.74 (95% CI 0.56–0.98)P=0.04Log-rank P = .04; adjusted hazard ratio 0.67 (95% CI 0.50 to 0.89). |
| OSPrimary analysis population: 1171 patients (586 robotic, 585 laparoscopic)3-year overall survival (secondary outcome) | primarymedian follow-up 43 monthsFeng 2025 | 94.7% at 3 y | 93% at 3 y | The abstract reports no significant between-group difference and gives no p-value. The full text gives hazard ratio 0.75 (95% CI 0.50 to 1.12), log-rank P = .16 (robotic relative to laparoscopic). |
| Positive circumferential resection marginModified intention-to-treat population with margin data (547 robotic, 543 laparoscopic)Circumferential resection margin positivity (key secondary endpoint in the short-term report) | interimFeng 2022 | 4% | 7.2% | P=0.02322 of 547 robotic and 39 of 543 laparoscopic patients; difference -3.2 percentage points (95% CI -6.0 to -0.4). Reported before the primary endpoint had matured. |
| Surgical complicationsModified intention-to-treat population (586 robotic, 585 laparoscopic)At least one postoperative complication of Clavien-Dindo grade II or higher within 30 days after surgery (key secondary endpoint in the short-term report) | interimFeng 2022 | 16.2% | 23.1% | P=0.00395 robotic and 135 laparoscopic patients; difference -6.9 percentage points (95% CI -11.4 to -2.3). |
| Conversion to open surgeryModified intention-to-treat population (586 robotic, 585 laparoscopic)Conversion to open surgery (secondary endpoint in the short-term report) | interimFeng 2022 | 1.7% | 3.9% | P=0.02110 robotic and 23 laparoscopic patients; difference -2.2 percentage points (95% CI -4.3 to -0.4). |
| Endpoint | Analysis | Robotic surgery | Conventional laparoscopic surgery | Effect |
|---|---|---|---|---|
| Locoregional recurrence after rectal surgeryPrimary analysis population: 1171 patients (586 robotic, 585 laparoscopic), analysed as randomised after excluding patients deemed ineligible after randomisation3-year locoregional recurrence rate (primary outcome) | primarymedian follow-up 43 monthsFeng 2025 | 1.6% at 3 y (0.6–2.6%) | 4% at 3 y (2.4–5.6%) | HR 0.45 (95% CI 0.22–0.92)P=0.03Hazard ratio 0.45 with log-rank P = .03; the full text calls robotic surgery a protective factor in the adjusted analyses, which fixes the direction as robotic relative to laparoscopic. The full text states that the total of 35 primary-outcome events fell short of the 81 planned and that the research committee decided to analyse the primary outcome regardless (9 robotic and 23 laparoscopic events). Adjusted hazard ratio 0.39 (95% CI 0.19 to 0.80). Median follow-up 43.0 months (IQR 36.7 to 60.0). |
| DFSPrimary analysis population: 1171 patients (586 robotic, 585 laparoscopic)3-year disease-free survival (secondary outcome) | primarymedian follow-up 43 monthsFeng 2025 | 87.2% at 3 y | 83.4% at 3 y | HR 0.74 (95% CI 0.56–0.98)P=0.04Log-rank P = .04; adjusted hazard ratio 0.67 (95% CI 0.50 to 0.89). |
| OSPrimary analysis population: 1171 patients (586 robotic, 585 laparoscopic)3-year overall survival (secondary outcome) | primarymedian follow-up 43 monthsFeng 2025 | 94.7% at 3 y | 93% at 3 y | The abstract reports no significant between-group difference and gives no p-value. The full text gives hazard ratio 0.75 (95% CI 0.50 to 1.12), log-rank P = .16 (robotic relative to laparoscopic). |
| Positive circumferential resection marginModified intention-to-treat population with margin data (547 robotic, 543 laparoscopic)Circumferential resection margin positivity (key secondary endpoint in the short-term report) | interimFeng 2022 | 4% | 7.2% | P=0.02322 of 547 robotic and 39 of 543 laparoscopic patients; difference -3.2 percentage points (95% CI -6.0 to -0.4). Reported before the primary endpoint had matured. |
| Surgical complicationsModified intention-to-treat population (586 robotic, 585 laparoscopic)At least one postoperative complication of Clavien-Dindo grade II or higher within 30 days after surgery (key secondary endpoint in the short-term report) | interimFeng 2022 | 16.2% | 23.1% | P=0.00395 robotic and 135 laparoscopic patients; difference -6.9 percentage points (95% CI -11.4 to -2.3). |
| Conversion to open surgeryModified intention-to-treat population (586 robotic, 585 laparoscopic)Conversion to open surgery (secondary endpoint in the short-term report) | interimFeng 2022 | 1.7% | 3.9% | P=0.02110 robotic and 23 laparoscopic patients; difference -2.2 percentage points (95% CI -4.3 to -0.4). |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| Locoregional recurrence after rectal surgery | 0.45 | 0.22–0.92 |
| DFS | 0.74 | 0.56–0.98 |
Appears in
Sources
Feng Q, Yuan W, Li T, Tang B, Jia B, Zhou Y, et al. Robotic vs Laparoscopic Surgery for Middle and Low Rectal Cancer: The REAL Randomized Clinical Trial. JAMA. 2025;334(2):136-148.
Feng Q, Yuan W, Li T, Tang B, Jia B, Zhou Y, et al. Robotic versus laparoscopic surgery for middle and low rectal cancer (REAL): short-term outcomes of a multicentre randomised controlled trial. Lancet Gastroenterol Hepatol. 2022;7(11):991-1004.