REAL (original research)
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
1171 patients.
Inclusion criteria: patients with middle or low rectal adenocarcinoma with no evidence of distant metastasis.
Key exclusion criteria: tumor assessed as clinical complete response after preoperative radio- or chemoradiotherapy or suitable for local excision; signs of acute intestinal obstruction, bleeding or perforation needing emergency surgery.
Interventions
N=586 robotic surgery (robot-assisted resection using da Vinci® system).
N=585 laparoscopic surgery (traditional laparoscopic resection).
Primary outcome
Circumferential resection margin positivity
4%
7.2%
7.2 %
5.4 %
3.6 %
1.8 %
0.0 %
Robotic
surgery
Laparoscopic
surgery
Significant
decrease ▼
NNT = 31
Significant decrease in circumferential resection margin positivity (4% vs. 7.2%; ARD -3.2, 95% CI -6 to -0.4).
Secondary outcomes
Significant decrease in postoperative complication ≥ grade II at day 30 (16.2% vs. 23.1%; ARD -6.9, 95% CI -11.4 to -2.3).
Significant increase in macroscopic complete resection (95.4% vs. 91.8%; AD 3.6%, 95% CI 0.8 to 6.5).
Significant decrease in postoperative hospital stay (7 days vs. 8 days; AD -1 days, 95% CI -1 to 0).
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 circumferential resection margin positivity.
Reference
Qingyang Feng, Weitang Yuan, Taiyuan Li 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 Nov;7(11):991-1004.
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