Aim: To clarify and evaluate the long-term outcomes of laparoscopic surgery for clinical stage 0/I rectal carcinoma patients. Methods: This single-arm phase II trial involved accredited surgeons from 43 Japanese institutions. Patients were registered preoperatively. The planned sample size was 490. The primary endpoint was overall survival, and long-term outcomes were evaluated. Results: A total of 495 patients were registered between February 2008 and August 2010. Eight patients (1.6%) required conversion to open surgery. Sphincter-preserving procedures were performed in 477 (97%) patients. Positive radial resection margin was found in two (0.4%) patients. Of 490 patients, 22, 314, 38, 115, and one patient had final pathological stages (p-stage) 0, I, II, III, and IV, respectively. Pathologically, 31.4% (154/490) of the patients did not have p-stage 0/I. The 5-year overall survival (OS) rates in p-stages 0, I, II, and III were 100%, 98%, 97%, and 94%, respectively. The 5-year OS of all patients at 96.6% (95% CI 94.6-97.9) was significantly better than the expected 5-year OS of 81.1% (P <.0001). The 5-year relapse-free survival in p-stages 0, I, II, and III were 100%, 93%, 81%, and 79%, respectively. The 5-year relapse-free survival of all patients was 90.1%. Fifty patients (10.2%) had recurrence; lung recurrence was found in 22 patients, local recurrence in 14, liver in seven, distant lymph node in nine, and bone in three. Conclusions: Laparoscopic surgery for clinical stage 0/I rectal carcinoma has feasible long-term outcomes. (ClinicalTrials.gov No.NCT00635466.).
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