COLOR III Short-Term Outcomes: taTME vs Laparoscopic TME
06/05/2026
Key Takeaways
- taTME was associated with lower conversion than laparoscopic TME in this short-term comparison.
- 90-day morbidity, anastomotic leakage, and macroscopically complete resection appeared similar between groups.
This international, open-label, phase 3 randomized trial was conducted at 28 hospitals and enrolled adults with (y)cT1-3N0-2M0 rectal adenocarcinoma within 10 cm of the anal verge. Patients were assigned 2:1 to transanal or laparoscopic TME through an interactive web-response system using minimization by sex, BMI, tumour stage, tumour height, radiotherapy, and downstaging. Quality assurance included pretrial video-based competency assessment and central MRI review for eligibility before surgery. Between Jan 2, 2017 and Jan 16, 2024, investigators screened 1205 patients and randomized 1103. This modified intention-to-treat cohort included 711 taTME and 350 LapTME patients and was predominantly male, with a median age of 63.0 years and BMI of 24.4 kg/m2.
Postoperative complications within 90 days occurred in 138 of 689 taTME patients and 59 of 335 LapTME patients, with an adjusted OR of 1.22 and a 95% CI of 0.90-1.64. Anastomotic leakage was recorded in 68 of 689 versus 27 of 333 patients, with an adjusted OR of 1.32 and 95% CI 0.83-2.08. Minor morbidity occurred in 61 of 689 versus 26 of 333 patients, while major morbidity affected 77 of 689 versus 31 of 333. For major morbidity, the adjusted OR was 1.23 with a 95% CI of 0.82-1.85.
Macroscopically complete resection was achieved in 583 of 692 taTME specimens and 291 of 339 LapTME specimens. The adjusted OR was 0.94, with a 95% CI of 0.58-1.51. Positive circumferential margins were rare, occurring in 4 of 611 versus 1 of 291 procedures, and positive distal margins in 7 of 690 versus 1 of 334.
Follow-up will continue for 3-year local recurrence and other functional and oncologic outcomes.