Effectiveness and safety of laparoscopic resection versus open surgery in patients with rectal cancer: a randomized, controlled trial from China.

BACKGROUND: The long-term survival and safety of laparoscopic surgery in patients with rectal cancer remain unclear. The aim of this trial was to assess the efficacy and safety of laparoscopic surgery for treatment of rectal cancer.

METHODS: We undertook a randomized, controlled trial in 343 patients with rectal cancer between May 2004 and April 2008. One hundred sixty-nine patients were randomly assigned to laparoscopic surgery and 174 patients to open surgery. The main endpoint was 3-year survival. Data were analyzed according to the intention-to-treat principle.

RESULTS: Laparoscopic surgery was associated with earlier recovery of bowel movement compared with open surgery. The average time to first discharge, bowel movement, resumption of fluid intake, and activity out of bed in laparoscopic surgery were shorter by 0.63, 0.32, 0.33, and 0.63 day, respectively (P < .001). The incidences of postoperative morbidities such as infectious complications, anastomotic leakage, anastomotic stenosis, and deep vein thrombosis have no differences. No differences were found in the comparison of long-term survival.

INTERPRETATION: Laparoscopic surgery for rectal cancer is as safe and effective as open surgery in terms of oncology outcomes. Long-term survival for patients with rectal cancer undergoing laparoscopic surgery were similar to those undergoing conventional open surgery, thus supporting the continued use of laparoscopic surgery in Chinese patients with rectal cancer.