TY - THES A1 - Fuhr, Sebastian T1 - Behandlungsoptionen Offene Abdomen Therapie - Entwicklung und Validierung eines multizentrischen Registers T1 - Treatment options Open Abdomen Therapy - Development and validation of a multicenter registry N2 - Die Offene Abdomen Therapie (OAT) stellt eine der größten Herausforderungen im Bereich der Chirurgie dar. Ziel war es ein offenes, kostenloses und internationales Register zu entwickeln, um eine Basis für zukünftige Therapien und den Weg zu einer evidenzbasierten Leitlinie zu legen. Es wurden 630 Fälle identifiziert welche mittels OAT behandelt wurden und im Rahmen einer gemischt retrospektiven als auch prospektiven Datenauswertung in das von uns entwickelte Register eingetragen. Schwerpunkte waren dabei einerseits die Praktikabilität des Registers zu testen als auch Einflussfaktoren für eine erfolgreiche OAT zu finden. Es konnte gezeigt werden, dass das Register in seiner Konzeption funktioniert und in der ersten Auswertungen Einflussfaktoren für eine erhöhte Faszienverschlussrate gefunden werden konnten. Der verbesserte Faszienverschluss am Ende der Therapie mit zeitgleich reduzierter Komplikationsrate ist möglich. Aus diesem Grund besitzt die konsequente Nutzung des Registers von behandelnden Einrichtungen, die wo immer mögliche lückenlose Dokumentation, sowie die multizentrische Auswertung der Daten einen hohen Stellenwert in Hinsicht auf Prävention, Therapie und Nachsorge der OAT. N2 - Open abdomen therapy (OAT) represents one of the greatest challenges in the field of surgery. The aim was to develop an open, free and international registry to provide a basis for future therapies and to pave the way for an evidence-based guideline. We identified 630 cases treated with OAT and entered them into the registry in a mixed retrospective and prospective data analysis. The main focus was to test the practicability of the registry as well as to find influencing factors for a successful OAT. It could be shown that the register works in its conception and in the first evaluations influencing factors for an increased fascial closure rate could be found. Improved fascial closure at the end of therapy with a simultaneously reduced complication rate is possible. For this reason, the consistent use of the registry by treating institutions, the complete documentation wherever possible, as well as the multicenter evaluation of the data is of high importance with regard to prevention, therapy and follow-up of OAT. KW - Chirurgie KW - Laparostomie KW - Laparotomie KW - Offene Abdomen Therapie KW - Open abdomen therapy KW - Registerstudie KW - Multizentrisches Register Y1 - 2022 U6 - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:20-opus-257080 ER - TY - JOUR A1 - Mc Laughlin, Anna M. A1 - Schmulenson, Eduard A1 - Teplytska, Olga A1 - Zimmermann, Sebastian A1 - Opitz, Patrick A1 - Groenland, Stefanie L. A1 - Huitema, Alwin D. R. A1 - Steeghs, Neeltje A1 - Müller, Lothar A1 - Fuxius, Stefan A1 - Illerhaus, Gerald A1 - Joerger, Markus A1 - Mayer, Frank A1 - Fuhr, Uwe A1 - Holdenrieder, Stefan A1 - Hempel, Georg A1 - Scherf-Clavel, Oliver A1 - Jaehde, Ulrich A1 - Kloft, Charlotte T1 - Developing a nationwide infrastructure for therapeutic drug monitoring of targeted oral anticancer drugs: the ON-TARGET study protocol JF - Cancers N2 - Exposure-efficacy and/or exposure-toxicity relationships have been identified for up to 80% of oral anticancer drugs (OADs). Usually, OADs are administered at fixed doses despite their high interindividual pharmacokinetic variability resulting in large differences in drug exposure. Consequently, a substantial proportion of patients receive a suboptimal dose. Therapeutic Drug Monitoring (TDM), i.e., dosing based on measured drug concentrations, may be used to improve treatment outcomes. The prospective, multicenter, non-interventional ON-TARGET study (DRKS00025325) aims to investigate the potential of routine TDM to reduce adverse drug reactions in renal cell carcinoma patients receiving axitinib or cabozantinib. Furthermore, the feasibility of using volumetric absorptive microsampling (VAMS), a minimally invasive and easy to handle blood sampling technique, for sample collection is examined. During routine visits, blood samples are collected and sent to bioanalytical laboratories. Venous and VAMS blood samples are collected in the first study phase to facilitate home-based capillary blood sampling in the second study phase. Within one week, the drug plasma concentrations are measured, interpreted, and reported back to the physician. Patients report their drug intake and toxicity using PRO-CTCAE-based questionnaires in dedicated diaries. Ultimately, the ON-TARGET study aims to develop a nationwide infrastructure for TDM for oral anticancer drugs. KW - therapeutic drug monitoring KW - oral anticancer drugs KW - renal cell carcinoma KW - volumetric absorptive microsampling Y1 - 2021 U6 - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:20-opus-252196 SN - 2072-6694 VL - 13 IS - 24 ER -