The aim of this study was to compare technical feasibility and both early and 5-year clinical outcomes of laparoscopic-assisted and open radical subtotal gastrectomy for distal gastric cancer. The role of laparoscopic surgery in the treatment of gastric cancer has not yet been defined, and many doubts remain about the ability to satisfy all the oncologic criteria met during conventional, open surgery. This study was designed as a prospective, randomized clinical trial with a total of 59 patients. Twenty-nine (49.1%) patients were randomized to undergo open subtotal gastrectomy (OG), while 30 (50.9%) patients were randomized to the laparoscopic group (LG). Demographics, ASA status, pTNM stage, histologic type of the tumor, number of resected lymph nodes, postoperative complications, and 5-year overall and disease-free survival rates were studied to assess outcome differences between the groups. The demographics, preoperative data, and characteristics of the tumor were similar. The mean number of resected lymph nodes was 33.4 +/- 17.4 in the OG group and 30.0 +/- 14.9 in the LG (P = not significant). Operative mortality rates were 6.7% (2 patients) in the OG and 3.3% (1 patient) in the LG (P = not significant); morbidity rates were 27.6% and 26.7%, respectively (P = not significant). Five-year overall and disease-free survival rates were 55.7% and 54.8% and 58.9% and 57.3% in the OG and the LG, respectively (P = not significant). Laparoscopic radical subtotal gastrectomy for distal gastric cancer is a feasible and safe oncologic procedure with short- and long-term results similar to those obtained with an open approach. Additional benefits for the LG were reduced blood loss, shorter time to resumption of oral intake, and earlier discharge from hospital.