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COLOR III

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Transanal total mesorectal excision versus laparoscopic total mesorectal excision for mid and low rectal cancer (COLOR III): short-term outcomes of an international, multicentre, phase 3, randomised, controlled, non-inferiority trial

Phase 3N = 1,103NCT02736942

Population
Patients with (y)cT1-3N0-2M0 rectal adenocarcinoma located 10 cm or less from the anal verge
Design
International, multicentre, open-label, phase 3, randomised, non-inferiority trial at 28 hospitals worldwide. Patients aged 18 years or older with (y)cT1-3N0-2M0 rectal adenocarcinoma 10 cm or less from the anal verge were randomised 2:1 to TaTME or laparoscopic TME with minimisation (January 2017 to January 2024). Primary endpoint 3-year local recurrence, assessed for non-inferiority; it is not yet reported, and this record holds the short-term secondary outcomes (modified intention-to-treat population: 711 TaTME, 350 laparoscopic TME).
Primary endpoint
Local recurrence after rectal surgery
Arms
  • Laparoscopic TME (control, n = 367): Laparoscopic total mesorectal excision
  • Transanal TME (experimental, n = 735): Transanal total mesorectal excision
People
Tuynman JB, COLOR III Study Group
Δ Conversion to open surgery−16 pointsΔ Surgical complications+2 pointsΔ Anastomotic leakage+2 points
Show the numbers
Results reported for COLOR III
EndpointAnalysisTransanal TMELaparoscopic TMEEffect
Conversion to open surgeryModified intention-to-treat population with data (696 TaTME, 339 laparoscopic TME)Conversion (short-term secondary endpoint)interimTuynman 20261%17%4 of 696 TaTME and 56 of 339 laparoscopic TME patients; adjusted odds ratio 0.03 (95% CI 0.01 to 0.08). The abstract states that conversion was significantly less frequent with TaTME.
Surgical complicationsModified intention-to-treat population with data (689 TaTME, 335 laparoscopic TME)Postoperative complications within 90 days (short-term secondary endpoint)interimTuynman 202620%18%138 of 689 TaTME and 59 of 335 laparoscopic TME patients; adjusted odds ratio 1.22 (95% CI 0.90 to 1.64). Major morbidity (Clavien-Dindo grade 3 or higher): 77 (11%) of 689 vs 31 (9%) of 333, adjusted odds ratio 1.23 (95% CI 0.82 to 1.85).
Anastomotic leakageModified intention-to-treat population with data (689 TaTME, 333 laparoscopic TME)Anastomotic leakage (short-term secondary endpoint)interimTuynman 202610%8%68 of 689 TaTME and 27 of 333 laparoscopic TME patients; adjusted odds ratio 1.32 (95% CI 0.83 to 2.08); the abstract states the incidence did not differ between groups.
Positive circumferential resection marginModified intention-to-treat population with margin data (611 TaTME, 291 laparoscopic TME)Positive circumferential resection margin (short-term secondary endpoint)interimTuynman 20261%—4 of 611 TaTME procedures versus 1 of 291 laparoscopic TME procedures (<1%, which the schema cannot hold, so only the TaTME rate is stored). Positive distal margin: 7 (1%) of 690 vs 1 (<1%) of 334.
Results reported for COLOR III
EndpointAnalysisTransanal TMELaparoscopic TMEEffect
Conversion to open surgeryModified intention-to-treat population with data (696 TaTME, 339 laparoscopic TME)Conversion (short-term secondary endpoint)interimTuynman 20261%17%4 of 696 TaTME and 56 of 339 laparoscopic TME patients; adjusted odds ratio 0.03 (95% CI 0.01 to 0.08). The abstract states that conversion was significantly less frequent with TaTME.
Surgical complicationsModified intention-to-treat population with data (689 TaTME, 335 laparoscopic TME)Postoperative complications within 90 days (short-term secondary endpoint)interimTuynman 202620%18%138 of 689 TaTME and 59 of 335 laparoscopic TME patients; adjusted odds ratio 1.22 (95% CI 0.90 to 1.64). Major morbidity (Clavien-Dindo grade 3 or higher): 77 (11%) of 689 vs 31 (9%) of 333, adjusted odds ratio 1.23 (95% CI 0.82 to 1.85).
Anastomotic leakageModified intention-to-treat population with data (689 TaTME, 333 laparoscopic TME)Anastomotic leakage (short-term secondary endpoint)interimTuynman 202610%8%68 of 689 TaTME and 27 of 333 laparoscopic TME patients; adjusted odds ratio 1.32 (95% CI 0.83 to 2.08); the abstract states the incidence did not differ between groups.
Positive circumferential resection marginModified intention-to-treat population with margin data (611 TaTME, 291 laparoscopic TME)Positive circumferential resection margin (short-term secondary endpoint)interimTuynman 20261%—4 of 611 TaTME procedures versus 1 of 291 laparoscopic TME procedures (<1%, which the schema cannot hold, so only the TaTME rate is stored). Positive distal margin: 7 (1%) of 690 vs 1 (<1%) of 334.
Primary publication: Tuynman JB, Yao H, Moolenaar LR, Sietses C, Hompes R, Aigner F, et al. Transanal total mesorectal excision versus laparoscopic total mesorectal excision for mid and low rectal cancer (COLOR III): short-term outcomes of an international, multicentre, phase 3, randomised, controlled, non-inferiority trial. Lancet Gastroenterol Hepatol. 2026;11(5):355-366. PubMedDOI

Appears in

Sources

  1. Tuynman JB, Yao H, Moolenaar LR, Sietses C, Hompes R, Aigner F, et al. Transanal total mesorectal excision versus laparoscopic total mesorectal excision for mid and low rectal cancer (COLOR III): short-term outcomes of an international, multicentre, phase 3, randomised, controlled, non-inferiority trial. Lancet Gastroenterol Hepatol. 2026;11(5):355-366.

    PubMedDOI