Nicole Ziegler1, Luz Angela Torres-de la Roche2, Rajesh Devassy2, Rudy Leon De Wilde2. 1. Pius Hospital, University Hospital for Gynecology, University Medicine Oldenburg, Carl von Ossietzky University, Georgstrasse 12, 26121, Oldenburg, Germany. nicole.ziegler@pius-hospital.de. 2. Pius Hospital, University Hospital for Gynecology, University Medicine Oldenburg, Carl von Ossietzky University, Georgstrasse 12, 26121, Oldenburg, Germany.
Abstract
INTRODUCTION: The development of peritoneal adhesions and the effects of different antiadhesion agents on such mechanisms are not fully understood. Temporary rises of the C-reactive protein (CRP) level have been reported after antiadhesion agent application. We present the changes of inflammation markers observed after use of a starch-based polysaccharide certified for adhesion prevention and hemostasis 4DF (4DryField® PH). METHOD: Retrospective comparative analysis of inflammation markers in 40 patients undergoing laparoscopic adhesiolysis with or without adhesion prophylaxis was conducted. Statistical comparisons were performed by means of paired or unpaired t tests (for normally distributed continuous data), Wilcoxon matched pairs signed-rank tests or Mann-Whitney tests (for not-normally distributed continuous data), Mantel-Cox tests (for continuous data describing time intervals), and Fisher's exact tests (for discrete data). RESULTS: The maximum post-operative CRP level was significantly elevated in the 4DF group (87 vs. 29%; p < 0.001), whereas leukocyte concentration and body temperature did not differ between groups. No signs of infection were detected in any of the patients and CRP levels spontaneously dropped to normal values within few days. No side effects or complications were observed in both groups. In second-look surgeries performed for other diagnoses 1-56 weeks after the first interventions, no remnants of 4DF or any peritoneal inflammatory reactions were observed. CONCLUSION: The starch-based polysaccharide 4DF can be considered safe and does not induce inflammatory reactions of clinical significance. Further studies regarding 4DF degradation are recommended and, apart from macrophage migration, could also examine corresponding markers such as IL-6 and PCT.
INTRODUCTION: The development of peritoneal adhesions and the effects of different antiadhesion agents on such mechanisms are not fully understood. Temporary rises of the C-reactive protein (CRP) level have been reported after antiadhesion agent application. We present the changes of inflammation markers observed after use of a starch-based polysaccharide certified for adhesion prevention and hemostasis 4DF (4DryField® PH). METHOD: Retrospective comparative analysis of inflammation markers in 40 patients undergoing laparoscopic adhesiolysis with or without adhesion prophylaxis was conducted. Statistical comparisons were performed by means of paired or unpaired t tests (for normally distributed continuous data), Wilcoxon matched pairs signed-rank tests or Mann-Whitney tests (for not-normally distributed continuous data), Mantel-Cox tests (for continuous data describing time intervals), and Fisher's exact tests (for discrete data). RESULTS: The maximum post-operative CRP level was significantly elevated in the 4DF group (87 vs. 29%; p < 0.001), whereas leukocyte concentration and body temperature did not differ between groups. No signs of infection were detected in any of the patients and CRP levels spontaneously dropped to normal values within few days. No side effects or complications were observed in both groups. In second-look surgeries performed for other diagnoses 1-56 weeks after the first interventions, no remnants of 4DF or any peritoneal inflammatory reactions were observed. CONCLUSION: The starch-based polysaccharide 4DF can be considered safe and does not induce inflammatory reactions of clinical significance. Further studies regarding 4DF degradation are recommended and, apart from macrophage migration, could also examine corresponding markers such as IL-6 and PCT.
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Authors: L A Torres-De La Roche; R Campo; R Devassy; A Di Spiezio Sardo; A Hooker; P Koninckx; B Urman; M Wallwiener; R L De Wilde Journal: Facts Views Vis Obgyn Date: 2019-06