6/27/23, 11:47 PM ACOSOG Z6051 Pathway Feedback Search Clinical Topics Home Studies ACOSOG Z6051 ACOSOG Z6051 Disease Rectal cancer Trial question Is laparoscopic resection noninferior to open resection in patients with stage II or III rectal cancer? Study design Multi-center Open label RCT Population Characteristics of study participants 35.0% female N = 481 65.0% male 481 patients (167 female, 314 male) Inclusion criteria: patients with clinical stage II or III rectal cancer within 12 cm of the anal verge Key exclusion criteria: history of invasive pelvic malignancy within 5 years, psychiatric or addictive disorders that affected compliance to the protocol, severe incapacitating disease, systemic disease that would preclude use of laparoscopic approach Interventions N=242 laparoscopic resection (laparoscopic-assisted rectal resection) N=239 open resection (open laparotomy and rectal resection) Primary outcome Successful resection https://web.pathway.md/studies/rec805EXPd3Ysj3gt 1/2 6/27/23, 11:47 PM ACOSOG Z6051 Pathway 86.9 % 86.9 81.7 65.2 % 43.5 % Difference exceeding nonferiority margin 21.7 % 0.0 % Laparoscopic resection Open resection Difference exceeding nonferiority margin in successful resection (81.7% vs. 86.9%; ARD -5.3, 95% CI -10.8 to Infinity) Secondary outcomes Significant increase in operative time (266.2 minutes vs. 220.6 minutes; AD 45.5 minutes, 95% CI 27.7 to 63.4) No significant difference in length of stay (7.3 days vs. 7 days; AD 0.3 days, 95% CI -0.6 to 1.1) No significant difference in the rate of readmission within 30 days (3.3% vs. 4.1%; AD -0.7%, 95% CI -4.2 to 2.7) Safety outcomes No significant difference in complications and severe complications. Conclusion In patients with clinical stage II or III rectal cancer within 12 cm of the anal verge, laparoscopic resection was not noninferior to open resection with respect to successful resection. Reference James Fleshman, Megan Branda, Daniel J Sargent et al. Effect of Laparoscopic-Assisted Resection vs Open Resection of Stage II or III Rectal Cancer on Pathologic Outcomes: The ACOSOG Z6051 Randomized Clinical Trial. JAMA. 2015 Oct 6;314(13):1346-55. Open reference URL https://web.pathway.md/studies/rec805EXPd3Ysj3gt 2/2