6/28/23, 12:07 AM ALaCaRT Pathway Feedback Search Clinical Topics Home Studies ALaCaRT ALaCaRT Disease Rectal cancer Trial question Is laparoscopic resection noninferior to open rectal resection in patients with rectal cancer? Study design Multi-center Open label RCT Population Characteristics of study participants 34.0% female N = 473 66.0% male 473 patients (162 female, 311 male) Inclusion criteria: patients with T1-T3 rectal adenocarcinoma < 15 cm from the anal verge Key exclusion criteria: T4 tumors or an involved circumferential resection margin; concurrent or previous invasive pelvic malignant tumor within 5 years of study enrolment Interventions N=238 laparoscopic surgery (laparoscopic-assisted rectal resection) N=235 open surgery (open laparotomy and rectal resection) Primary outcome Successful resection 89 89 0 % https://web.pathway.md/studies/recFw6XBM7RklZzJp 1/2 6/28/23, 12:07 AM 89.0 % ALaCaRT Pathway 89 82 66.8 % 44.5 % Difference exceeding nonferiority margin 22.3 % 0.0 % Laparoscopic surgery Open surgery Difference exceeding nonferiority margin in successful resection (82% vs. 89%; ARD -7, 95% CI -12.4 to Infinity) Secondary outcomes No significant difference in clear circumferential resection margin (93% vs. 97%; ARD -3.7, 95% CI -7.6 to 0.1) Significant increase in median duration of operation (210 minutes vs. 190 minutes; AD 20 minutes, 95% CI 5.47 to 34.53) No significant difference in length of hospital stay (8 days vs. 8 days; RR 1, 95% CI -0.56 to 2.56) Safety outcomes No significant difference in grade 3-4 postoperative complications. Conclusion In patients with T1-T3 rectal adenocarcinoma < 15 cm from the anal verge, laparoscopic surgery was not noninferior to open surgery with respect to successful resection. Reference Andrew R L Stevenson, Michael J Solomon, John W Lumley et al. Effect of Laparoscopic-Assisted Resection vs Open Resection on Pathological Outcomes in Rectal Cancer: The ALaCaRT Randomized Clinical Trial. JAMA. 2015 Oct 6;314(13):1356-63. Open reference URL https://web.pathway.md/studies/recFw6XBM7RklZzJp 2/2