LASRE
Trial question
Is laparoscopic surgery noninferior to open surgery in patients with low rectal cancer?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
40.0% female
60.0% male
N = 1039
1039 patients (419 female, 620 male).
Inclusion criteria: patients aged 18-75 years with rectal adenocarcinoma within 5 cm from the dentate line.
Key exclusion criteria: diagnosis of invasive cancer within 5 years; locally advanced cancer requiring en bloc multivisceral resection; intestinal obstruction; intestinal perforation; history of colorectal surgery; mental disorder; pregnancy/lactation.
Interventions
N=685 laparoscopic surgery (laparoscopic-assisted rectal resection).
N=354 open surgery (conventional open rectal resection).
Primary outcome
Disease-free survival at 3 years
81.4%
79.8%
81.4 %
61.1 %
40.7 %
20.4 %
0.0 %
Laparoscopic
surgery
Open
surgery
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in disease-free survival at 3 years (81.4% vs. 79.8%; HR 0.92, 95% CI 0.69 to 1.23).
Secondary outcomes
No significant difference in overall survival at 3 years (91.7% vs. 93.7%; HR 1.34, 95% CI 0.82 to 2.19).
No significant difference in locoregional recurrence at 3 years (3.7% vs. 2.3%; HR 1.64, 95% CI 0.74 to 3.63).
No significant difference in overall survival at 5 years (84.6% vs. 86.6%; HR 1.16, 95% CI 0.82 to 1.64).
Conclusion
In patients aged 18-75 years with rectal adenocarcinoma within 5 cm from the dentate line, laparoscopic surgery was noninferior to open surgery with respect to a disease-free survival at 3 years.
Reference
Weizhong Jiang, Jianmin Xu, Ming Cui et al. Laparoscopy-assisted versus open surgery for low rectal cancer (LASRE): 3-year survival outcomes of a multicentre, randomised, controlled, non-inferiority trial. Lancet Gastroenterol Hepatol. 2025 Jan;10(1):34-43.
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