BACKGROUND: Although a novel technique for the performance of intestinal sutureless anastomosis using a compression device has recently been investigated, it has not yet received widespread acceptance. We performed a multicenter prospective randomized trial in order to determine the clinical efficacy of the NiTi Hand CAC 30, a type of compression anastomosis clip (CAC), for jejunojejunostomy in gastric cancer surgery. METHODS:Forty-seven patients from 6 institutions, who were diagnosed with gastric adenocarcinoma, were enrolled; these patients were randomized to a CAC group and a hand-sewn (control) group. Three patients dropped out for various reasons, and results for 44 patients were finally analyzed. The CAC group consisted of 20 patients, and there were 24 patients in the control group. RESULTS:Anastomosis time, the primary endpoint of this trial, was shorter in the CAC group than in the control group (P < 0.001). However, total operation times (P = 0.055) did not differ. All reconstructions were completed by Roux-en-Y anastomosis, and the complication rates of the two groups did not differ (P = 0.908); however, jejunojejunostomy leakage occurred in two patients in the CAC group. CONCLUSIONS: Our prospective multicenter clinical trial showed that the use of the NiTi Hand CAC™ 30 for jejunojejunostomy in gastric cancer surgery was feasible and could reduce anastomosis time. However, considering that there were two cases of leakage, extended use of the NiTi Hand CAC™ 30 should be carefully applied.
RCT Entities:
BACKGROUND: Although a novel technique for the performance of intestinal sutureless anastomosis using a compression device has recently been investigated, it has not yet received widespread acceptance. We performed a multicenter prospective randomized trial in order to determine the clinical efficacy of the NiTi Hand CAC 30, a type of compression anastomosis clip (CAC), for jejunojejunostomy in gastric cancer surgery. METHODS: Forty-seven patients from 6 institutions, who were diagnosed with gastric adenocarcinoma, were enrolled; these patients were randomized to a CAC group and a hand-sewn (control) group. Three patients dropped out for various reasons, and results for 44 patients were finally analyzed. The CAC group consisted of 20 patients, and there were 24 patients in the control group. RESULTS: Anastomosis time, the primary endpoint of this trial, was shorter in the CAC group than in the control group (P < 0.001). However, total operation times (P = 0.055) did not differ. All reconstructions were completed by Roux-en-Y anastomosis, and the complication rates of the two groups did not differ (P = 0.908); however, jejunojejunostomy leakage occurred in two patients in the CAC group. CONCLUSIONS: Our prospective multicenter clinical trial showed that the use of the NiTi Hand CAC™ 30 for jejunojejunostomy in gastric cancer surgery was feasible and could reduce anastomosis time. However, considering that there were two cases of leakage, extended use of the NiTi Hand CAC™ 30 should be carefully applied.