Surgical site infections following short-term radiotherapy and total mesorectal excision: results of a randomized study examining the role of gentamicin collagen implant in rectal cancer surgery

Abstract

BackgroundDespite 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).MethodsIn 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.ResultsThere 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.ConclusionsApplication 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.

The matrix metalloproteinase-7 and pro-enzyme of metalloproteinase-1 as a potential marker for patients with rectal cancer without distant metastasis

“…All the patients gave their informed consent to participate in the study. The selection of patients and the method of treatment were described in advance [15,16]. The clinicopathological characteristic of patients is introduced in Table 1.…”

The gentamicin-collagen implant and the risk of distant metastases of rectal cancer following short-course radiotherapy and curative resection: the long-term outcomes of a randomized study

“…Referring to the results of our research, two facts may have a critical role. Firstly, GCI applied into the pelvic cavity after short-term preoperative radiotherapy and TME may reduce the risk of organ-space surgical site infections (SSI) and local inflammatory reactions [5]. Secondly, the positive effect of GCI was observed mainly in a subgroup of patients who underwent surgery immediately after the short-term radiotherapy completion (unplanned analysis—data not shown).…”

“…The technique of preoperative irradiation was described previously [5]. Surgery was performed within 6 days after the completion of radiotherapy.…”

“…Finally, we decided to conduct a confirmatory randomized trial because type I error might occur (false positive results). The results of this trial showing postoperative complications were published elsewhere [5]. The aim of this article is to present long-term results.…”

Prophylactic negative pressure wound therapy in colorectal surgery. Effects on surgical site events: current status and call to action

“…Patients diagnosed with malignancies often need multimodal treatment, including radiotherapy and chemotherapy, or combined radiochemotherapy, which can be administered preoperatively [82][83][84][85][86][87][88][89]. These cause therapeutic immunodepression, but might increase the risk of surgical site events.…”