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Definition of AL The definition of AL in this study is clinical: AL was considered present when suspicious symptoms or signs of AL such as abdominal pain with tenderness and/or muscle guarding, fever (body temperature > 38��), rectovesical or rectovaginal fistula, pus or fecal discharge from the drain, discharge of abnormal material per rectum or chronic ileus (no improvement over 7 days) developed, and the diagnosis was confirmed by one or more of the following exams: CT scan, sigmoidoscopy, or laparotomy. For the CT scan, air bubble and/or fluid collection around the anastomotic see more site after the 7th postoperative day occurred in patients with suspected signs mentioned above was considered as AL. Statistical analysis To compare the three groups, the Fisher exact test was performed for categorical data, and the analysis of variance test was performed for continuous data. When there was a significant difference, the Sceffe or Games-Howell method was adopted for inter-group analysis. Non-inferiority of the TAT in preventing AL compared to loop ileostomy was tested with the independent t test. Statistical significance was defined as P for the statistical program. RESULTS In total, 578 consecutive surgical patients were diagnosed with primary rectal cancer during the study period. According to the inclusion criteria, 137 patients were enrolled as CAPNS1 follows: 67, 35, and 35 patients in the ileostomy, TAT, and no-protection groups, respectively (Table 1). The average level of tumor was 8.5 �� 1.5 cm (range, 5-10 cm) above the anal verge, and there were no significant differences in age, gender, tumor level, history of previous abdominal surgery, preoperative serum hemoglobin and albumin levels, operator, anastomosis type, and surgical procedure type among the groups. BMI of the no-protection group was statisctically lower than that of the ileostomy group or TAT group (P = 0.028), but intergroup analysis showed no statistical differences between the ileostomy and TAT groups. Table 1 Clinicopathological characteristics of 137 patients enrolled in this study Operative and pathologic outcomes (Table 2) showed no significant difference in concomitant resection of other intra-abdominal organs, Selleckchem Dolutegravir intraoperative transfusion, TNM stage, tumor size and distal resection margin. Most patients (122/137, 89.1%) received laparoscopic operations. However, operation time was longer in the ileostomy group (286.8 �� 66.2 > 238.9 �� 71.6, 256.0 �� 61.5, P = 0.029), and more estimated blood loss was observed (418.0 �� 355.1 > 244.3 �� 178.5, 346.7 �� 225.7, P = 0.018). Table 2 Operative and pathologic outcomes Regarding the postoperative course, patients in the ileostomy group resumed their diets more than 1 day earlier than the other groups (P