Abstract
PURPOSE: The aim of this prospective multi-center registry was to evaluate the safety and clinical performance of INTERCEED(®) in laparoscopic colorectal surgery. METHODS: This study was a prospective, multi-center, single-arm registry wherein patients who received INTERCEED(®) in laparoscopic colorectal surgery were registered consecutively (UMIN-CTR 00001872). The primary outcome was the incidence rate of postoperative adhesive small intestinal obstruction within 6 months. The secondary outcomes were reoperation related to postoperative bleeding and anastomotic leak, surgical site infection (SSI) and anastomotic leak. RESULTS: Between March 2012 and March 2015, a total of 202 patients were enrolled from six institutions. INTERCEED(®) was not applied in two patients, so 200 patients were analyzed using the full analysis set population. The incidence rate of postoperative adhesive intestinal obstruction was 1.0% (2/200). The total SSI rate was 3.5% (7/200), the deep incisional SSI rate was 0.0% (0/200), and the organ SSI rate was 0.0% (0/200). The incidence of anastomotic leak was 1.0% (2/200). Reoperation was performed in two cases: one for anastomotic leak and the other as cardiac surgery due to heart disease. CONCLUSIONS: Using INTERCEED(®) in laparoscopic colorectal surgery is safe and may be useful for preventing postoperative adhesive small intestinal obstruction.