Effect of Biologic Material Reinforcement on Surgical Anastomosis After Gastrectomy-A Pilot Study

Abstract

Background: Acellular dermal matrix is a biologic material derived from the skin of human cadaveric donors. It has been used successfully in the past to reduce complications in breast surgery and hernia repair. This investigation was aimed at assessing the feasibility of using acellular dermal matrix to support the anastomosis after gastrectomy with the aim of reducing anastomotic site leakage complications. Methods: Patients were randomly assigned to standard anastomotic reconstruction (control arm) or anastomotic reconstruction with acellular dermal matrix reinforcement (intervention arm). Surgical outcomes related to anastomotic complications were collected. Because actual anastomotic leaks found on imaging studies are infrequent and thus require a very high number of patient recruitment to detect statistically significant difference between the two groups, in this pilot investigation other clinical and laboratory measures that have been shown to correlate to or predict anastomotic leaks were also collected. Each surgical outcome was compared. Results: A total of 94 patients (intervention arm: 50, control arm: 44), were included in the analysis. Two patients in the control arm (4.55%) and one patient in the intervention arm (2.00%) experienced anastomotic leakage (p = 0.598), a difference without statistical significance. However, average postoperative C-reactive protein (CRP) levels and NUn scores, both of which have been shown to reflect likelihood of progressing to anastomotic leakage, were significantly lower for the intervention arm. The control arm showed an average CRP level of 128.77 mg/dL (SD: 97.08) while the intervention arm showed 77.38 mg/dL (SD: 49.08, p = 0.049). Conclusions: Leakage rate reduction with acellular dermal matrix reinforcement of anastomotic site was not detected in this investigation. However, postoperative inflammation levels and numerical predictors of anastomotic leakage development were significantly lower with acellular dermal matrix reinforcement of surgical anastomosis. This finding is worthy of further investigation, as reduction of inflammation with anastomotic site reinforcement is a novel finding, and more in-depth research may lead to discoveries on the physiologic role of the surgical anastomosis in post-gastrectomy patients. In addition, lower CRP and NUn scores for the intervention arm suggest potential for larger studies to detect reduction in clinical leak rates after acellular dermal matrix reinforcement.