Impact of the starch-based anti-adhesive agent 4DryField PH on anastomotic healing after rectal surgery

Abstract

Postoperative adhesions cause medical and socio-economic problems. 4DryField PH (4DF) is a starch-based medical product/agent with approved anti-adhesive and haemostatic effects. However, the influence on anastomotic healing has not yet been evaluated. The purpose of this study was, therefore, to characterize the effects of intraoperatively applied 4DF on the incidence of anastomotic leakage (AL) after rectal surgery. In this retrospective, monocentric cohort study, 157 patients after rectal surgery and primary anastomosis were divided into two groups. One group received 4DF (n=57), the other was treated without 4DF application (n=100). The groups were followed up for confirmed ALs. The rate of ALs (P=0.850) proved to be comparable. Other additional outcome parameters like postoperative hospital stay (P=0.801), wound infection rate (P=0.627), re-admission rate (P=1.000), re-operation rate (P=0.533) and the 30-day mortality (P=0.463) also showed no statistically significant differences. A multivariable regression model for the complete cohort could not identify 4DF application as prognostically relevant for the development of AL, whereas rectal cancer (OR=2.660 [1.184–5.974]; P=0.018), smoking (OR=3.555 [1.326–9.533]; P=0.012), an ASA (American Society of Anaesthesiologists) score ≥3 (OR=2.894 [1.300–6.442]; P=0.009) and male sex (OR=2.411 [1.040–5.591]; P=0.040) were determined as independent risk factors. The application of 4DF in proximity to the anastomotic region after rectal surgery did not increase the risk of AL and showed no impact on other investigated outcome parameters.