BACKGROUND This study aims to analyze the risk factors for anastomotic leakage after low anterior resection with the technique of total mesorectal excision (TME). METHODS From September 1993 to November 1998, 196 patients with rectal cancer from 3 to 12 cm from the anal verge were treated with low anterior resection with TME. The data were entered in a prospective manner, and the factors that might affect anastomotic leakage were analyzed. RESULTS The mean level of anastomosis was 3.6 cm from the anal verge (range 1 to 5 cm). The leakage rate was 10.2%. Female gender (P = 0.01; 95% confidence interval [CI] 1.3 to 14.3; odds ratio 4.3) and presence of a diversion stoma (P = 0.01; 95% CI 1.4 to 14.2; odds ratio 4.5) were independent significant factors for lower anastomotic leakage. The absence of a stoma was associated with significantly increased leakage in male (P = 0.001) but not in female (P = 0.51) patients. CONCLUSIONS With low anastomosis after low anterior resection with TME, diversion stoma construction should be performed routinely in men. In women, the need for diversion can be more selective.