TaLaR
Trial question
Is transanal total mesorectal excision noninferior to laparoscopic total mesorectal excision in patients with mid-low rectal cancer?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
36.0% female
64.0% male
N = 1089
1089 patients (397 female, 692 male).
Inclusion criteria: adult patients aged 18-75 years with clinical stage I-III rectal adenocarcinoma below the peritoneal reflection.
Key exclusion criteria: T1 cancers amenable to local resection; confirmed involvement of the circumferential resection margin by preoperative imaging; abdominoperineal resection; tumors involving the internal sphincter or levator ani; contraindications to surgery.
Interventions
N=544 transanal TME (rectum mobilized and resected transanally according to total mesorectal excision principles).
N=545 laparoscopic TME (traditional laparoscopic total mesorectal excision performed via standard laparoscopic techniques).
Primary outcome
Disease-free survival at 3 years
82.1%
79.4%
82.1 %
61.6 %
41.0 %
20.5 %
0.0 %
Transanal
TME
Laparoscopic
TME
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in disease-free survival at 3 years (82.1% vs. 79.4%; HR 0.86, 97.5% CI 0.63 to 1.18).
Secondary outcomes
No significant difference in local recurrence at 3 years (3.6% vs. 4.4%; HR 0.81, 95% CI 0.44 to 1.49).
No significant difference in overall survival at 3 years (92.6% vs. 90.7%; HR 1.28, 95% CI 0.84 to 1.92).
No significant difference in the rate of overall first-time recurrence within 3 years (15.8% vs. 17.6%; HR 0.88, 95% CI 0.66 to 1.18).
Conclusion
In adult patients aged 18-75 years with clinical stage I-III rectal adenocarcinoma below the peritoneal reflection, transanal TME was noninferior to laparoscopic TME with respect to a disease-free survival at 3 years.
Reference
Ziwei Zeng, Shuangling Luo, Hong Zhang et al. Transanal vs Laparoscopic Total Mesorectal Excision and 3-Year Disease-Free Survival in Rectal Cancer: The TaLaR Randomized Clinical Trial. JAMA. 2025 Jan 23. Online ahead of print.
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