RESUMEN
BACKGROUND: Despite the findings of several randomized clinical studies, the role of gentamicin collagen implant (GCI) in rectal cancer surgery is unclear. Local pelvic application of GCI following preoperative radiotherapy and total mesorectal excision (TME) was evaluated to determine the risk of surgical site infections (SSI). METHODS: In this single-center trial, 176 patients with rectal cancer after preoperative, short-term radiotherapy (5 × 5 Gy) were randomized either to the study group in which GCI was used or in the control group without GCI. Prior to surgery and intraoperatively five patients were excluded from the study. The remaining 171 patients were analyzed; 86 were in the study group and 85 in the control group. RESULTS: There were no statistically significant differences in the overall rate of early postoperative complications between the study and control group: 25.6 and 34.1 % respectively; p = 0.245, relative risk (RR) 0.750 [95 % confidence interval (CI) 0.471-1.195]. The reoperation rate was similar in both groups: 12.8 versus 9.4 %; p = 0.628; RR 1.359; (95 % CI 0.575-3.212). The total rate of SSI and organ space SSI were 22.2 and 15.8 % without differences between the study and control group. In patients without anastomotic leakage, the risk of organ space SSI was significantly reduced in patients who received GCI: 2.6 versus 13.0 %; p = 0.018. CONCLUSIONS: Application of GCI in the pelvic cavity after short-term preoperative radiotherapy and TME may reduce the risk of organ space SSI but only in the absence of anastomotic leakage.