Background: Billroth I (B-I) and Roux-en-Y (R-Y) reconstructions are commonly performed after distal gastrectomy. Which reconstruction procedure is superior remains controversial. We conducted a randomized controlled trial to compare the clinical efficacy of B-I and R-Y. Methods: Between August 2005 and December 2008, a total of 332 patients with potentially curable gastric cancer enrolled from 18 institutions were intraoperatively randomized to either the B-I group or the R-Y group. Postoperative morbidity and hospital mortality were recorded prospectively in a fixed format and were compared between these two groups. Results: The operating time was significantly longer in the R-Y group than in the B-I group (214 vs. 180 minutes, P < 0.0001). Regarding clinical symptoms during the postoperative hospital stay, the incidence of nausea, vomiting, and discontinuance of food intake was significantly higher in the R-Y group than in the B-I group (12.4% vs. 3.7%, P = 0.0027; 8.9% vs. 3.1%, P = 0.022; and 12.4% vs. 4.3%, P = 0.0064, respectively). There was no significant difference in the overall operative morbidity rate between the R-Y and B-I groups (13.6% vs. 8.6%, respectively, P = 0.14). Anastomotic leakage occurred in two patients (1.2%) in the B-I group and in none in the R-Y group; the difference did not reach statistical significance (P = 0.09). Postoperative hospital stay was significantly longer in the R-Y group than in the B-I group (16.4 vs. 14.1 days, P = 0.019). Conclusions: We concluded that B-I reconstruction was superior to R-Y reconstruction in terms of perioperative complications.
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