Clinical trial NCT00700141: Non-Interventional Study About Treatment of Hemorrhages in Thyroid Surgery With TachoSil®
Official title: Non-Interventional Study on the Use of TachoSil® During Thyroid Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemorrhage
Keywords: Tachosil
thyroid
parathyroid
fleece-bound hemostasispathologic processes
hemorrhage
thyroid surgery
Lead sponsor: Nycomed
Sponsor class: INDUSTRY
First posted: 2008-06-18
Enrollment: 482
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inpatients

Brief summary: Considering the total number of thyroid procedures in Germany (100000 - 120000 cases per year), TachoSil® is a valuable tool to support surgical haemostasis, avoiding lymph leaks and support speech-nerve saving approaches. The aim of this study was to evaluate a patient and procedure profile where TachoSil® is most beneficial.


Eligibility criteria: Main Inclusion Criteria:

* Patients undergoing total or subtotal thyroidectomy

Main Exclusion Criteria:

* Contraindications, such as hypersensitivity to the active pharmaceutical ingredient or to another ingredient

Primary outcomes:
measure: Assessment of TachoSil® by the Surgeon With Respect to Handling, Utility and Satisfaction in the Operation, Documented Using 10 Point Numerical Rating Scales
timeFrame: after surgery
Secondary outcomes:
measure: Pharmacoeconomic Benefits as Assessed by the Surgeon
timeFrame: peri- and post-surgery until hospital discharge
Other outcomes:
Locations:
city: Aschaffenburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Aschersleben
country: Germany
facility: Nycomed Deutschland GmbH
city: Bad Berka
country: Germany
facility: Nycomed Deutschland GmbH
city: Bad Salzungen
country: Germany
facility: Nycomed Deutschland GmbH
city: Bad Tölz
country: Germany
facility: Nycomed Deutschland GmbH
city: Baden-Baden
country: Germany
facility: Nycomed Deutschland GmbH
city: Bayreuth
country: Germany
facility: Nycomed Deutschland GmbH
city: Berlin
country: Germany
facility: Nycomed Deutschland GmbH
city: Berlin
country: Germany
facility: Nycomed Deutschland GmbH
city: Berlin
country: Germany
facility: Nycomed Deutschland GmbH
city: Berlin
country: Germany
facility: Nycomed Deutschland GmbH
city: Berlin
country: Germany
facility: Nycomed Deutschland GmbH
city: Bielefeld
country: Germany
facility: Nycomed Deutschland GmbH
city: Bielefeld
country: Germany
facility: Nycomed Deutschland GmbH
city: Bischofswerda
country: Germany
facility: Nycomed Deutschland GmbH
city: Bochum
country: Germany
facility: Nycomed Deutschland GmbH
city: Bonn
country: Germany
facility: Nycomed Deutschland GmbH
city: Bottrop
country: Germany
facility: Nycomed Deutschland GmbH
city: Braunschweig
country: Germany
facility: Nycomed Deutschland GmbH
city: Bruchsal
country: Germany
facility: Nycomed Deutschland GmbH
city: Chemnitz
country: Germany
facility: Nycomed Deutschland GmbH
city: Coswig
country: Germany
facility: Nycomed Deutschland GmbH
city: Cottbus
country: Germany
facility: Nycomed Deutschland GmbH
city: Deggendorf
country: Germany
facility: Nycomed Deutschland GmbH
city: Detmold
country: Germany
facility: Nycomed Deutschland GmbH
city: Dinkelsbühl
country: Germany
facility: Nycomed Deutschland GmbH
city: Dortmund
country: Germany
facility: Nycomed Deutschland GmbH
city: Duisburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Düsseldorf
country: Germany
facility: Nycomed Deutschland GmbH
city: Düsseldorf
country: Germany
facility: Nycomed Deutschland GmbH
city: Düsseldorf
country: Germany
facility: Nycomed Deutschland GmbH
city: Eberswalde
country: Germany
facility: Nycomed Deutschland GmbH
city: Eckernförde
country: Germany
facility: Nycomed Deutschland GmbH
city: Eichsfeld
country: Germany
facility: Nycomed Deutschland GmbH
city: Eisenach
country: Germany
facility: Nycomed Deutschland GmbH
city: Erfurt
country: Germany
facility: Nycomed Deutschland GmbH
city: Erlangen
country: Germany
facility: Nycomed Deutschland GmbH
city: Essen
country: Germany
facility: Nycomed Deutschland GmbH
city: Essen
country: Germany
facility: Nycomed Deutschland GmbH
city: Frankfurt (Oder)
country: Germany
facility: Nycomed Deutschland GmbH
city: Frankfurt
country: Germany
facility: Nycomed Deutschland GmbH
city: Frechen
country: Germany
facility: Nycomed Deutschland GmbH
city: Freudenstadt
country: Germany
facility: Nycomed Deutschland GmbH
city: Fürstenfeldbruck
country: Germany
facility: Nycomed Deutschland GmbH
city: Fürth
country: Germany
facility: Nycomed Deutschland GmbH
city: Gelnhausen
country: Germany
facility: Nycomed Deutschland GmbH
city: Gelsenkirchen
country: Germany
facility: Nycomed Deutschland GmbH
city: Gera
country: Germany
facility: Nycomed Deutschland GmbH
city: Gummersbach
country: Germany
facility: Nycomed Deutschland GmbH
city: Göppingen
country: Germany
facility: Nycomed Deutschland GmbH
city: Görlitz
country: Germany
facility: Nycomed Deutschland GmbH
city: Hagen
country: Germany
facility: Nycomed Deutschland GmbH
city: Halle
country: Germany
facility: Nycomed Deutschland GmbH
city: Hamburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Hamburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Hamburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Hamburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Hamburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Hamm
country: Germany
facility: Nycomed Deutschland GmbH
city: Hanau
country: Germany
facility: Nycomed Deutschland GmbH
city: Hartmannsdorf
country: Germany
facility: Nycomed Deutschland GmbH
city: Hausham
country: Germany
facility: Nycomed Deutschland GmbH
city: Heilbronn
country: Germany
facility: Nycomed Deutschland GmbH
city: Heinsberg
country: Germany
facility: Nycomed Deutschland GmbH
city: Herten
country: Germany
facility: Nycomed Deutschland GmbH
city: Ibbenbüren
country: Germany
facility: Nycomed Deutschland GmbH
city: Ingolstadt
country: Germany
facility: Nycomed Deutschland GmbH
city: Jena
country: Germany
facility: Nycomed Deutschland GmbH
city: Karlsruhe
country: Germany
facility: Nycomed Deutschland GmbH
city: Karlsruhe
country: Germany
facility: Nycomed Deutschland GmbH
city: Kassel
country: Germany
facility: Nycomed Deutschland GmbH
city: Kassel
country: Germany
facility: Nycomed Deutschland GmbH
city: Konstanz
country: Germany
facility: Nycomed Deutschland GmbH
city: Köln-Lindenthal
country: Germany
facility: Nycomed Deutschland GmbH
city: Köln
country: Germany
facility: Nycomed Deutschland GmbH
city: Langen
country: Germany
facility: Nycomed Deutschland GmbH
city: Leipzig
country: Germany
facility: Nycomed Deutschland GmbH
city: Leipzig
country: Germany
facility: Nycomed Deutschland GmbH
city: Lichtenfels
country: Germany
facility: Nycomed Deutschland GmbH
city: Lohr am Main
country: Germany
facility: Nycomed Deutschland GmbH
city: Luckenwalde
country: Germany
facility: Nycomed Deutschland GmbH
city: Lörrach
country: Germany
facility: Nycomed Deutschland GmbH
city: Lübbecke
country: Germany
facility: Nycomed Deutschland GmbH
city: Lübeck
country: Germany
facility: Nycomed Deutschland GmbH
city: Magdeburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Mainz
country: Germany
facility: Nycomed Deutschland GmbH
city: Mainz
country: Germany
facility: Nycomed Deutschland GmbH
city: Mannheim
country: Germany
facility: Nycomed Deutschland GmbH
city: Mannheim
country: Germany
facility: Nycomed Deutschland GmbH
city: Marburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Meppen
country: Germany
facility: Nycomed Deutschland GmbH
city: Mettmann
country: Germany
facility: Nycomed Deutschland GmbH
city: München
country: Germany
facility: Nycomed Deutschland GmbH
city: Münster
country: Germany
facility: Nycomed Deutschland GmbH
city: Münster
country: Germany
facility: Nycomed Deutschland GmbH
city: Neu-Ulm
country: Germany
facility: Nycomed Deutschland GmbH
city: Neumarkt in der Oberpfalz
country: Germany
facility: Nycomed Deutschland GmbH
city: Neumünster
country: Germany
facility: Nycomed Deutschland GmbH
city: Neuruppin
country: Germany
facility: Nycomed Deutschland GmbH
city: Nordhausen
country: Germany
facility: Nycomed Deutschland GmbH
city: Nürnberg
country: Germany
facility: Nycomed Deutschland GmbH
city: Oberhausen
country: Germany
facility: Nycomed Deutschland GmbH
city: Oldenburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Oldenburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Pforzheim
country: Germany
facility: Nycomed Deutschland GmbH
city: Potsdam
country: Germany
facility: Nycomed Deutschland GmbH
city: Prien am Chiemsee
country: Germany
facility: Nycomed Deutschland GmbH
city: Radebeul
country: Germany
facility: Nycomed Deutschland GmbH
city: Rathenow
country: Germany
facility: Nycomed Deutschland GmbH
city: Recklinghausen
country: Germany
facility: Nycomed Deutschland GmbH
city: Regensburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Regensburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Rheda-Wiedenbrück
country: Germany
facility: Nycomed Deutschland GmbH
city: Rosenheim
country: Germany
facility: Nycomed Deutschland GmbH
city: Rostock
country: Germany
facility: Nycomed Deutschland GmbH
city: Sangerhausen
country: Germany
facility: Nycomed Deutschland GmbH
city: Schwedt
country: Germany
facility: Nycomed Deutschland GmbH
city: Schweinfurth
country: Germany
facility: Nycomed Deutschland GmbH
city: Singen
country: Germany
facility: Nycomed Deutschland GmbH
city: Solingen
country: Germany
facility: Nycomed Deutschland GmbH
city: Stuttgart
country: Germany
facility: Nycomed Deutschland GmbH
city: Traunstein
country: Germany
facility: Nycomed Deutschland GmbH
city: Trostberg
country: Germany
facility: Nycomed Deutschland GmbH
city: Ulm
country: Germany
facility: Nycomed Deutschland GmbH
city: Ulm
country: Germany
facility: Nycomed Deutschland GmbH
city: Weimar
country: Germany
facility: Nycomed Deutschland GmbH
city: Weißenfels
country: Germany
facility: Nycomed Deutschland GmbH
city: Wiesbaden
country: Germany
facility: Nycomed Deutschland GmbH
city: Wiesbaden
country: Germany
facility: Nycomed Deutschland GmbH
city: Wipperfurth
country: Germany
facility: Nycomed Deutschland GmbH
city: Wismar
country: Germany
facility: Nycomed Deutschland GmbH
city: Würzburg
country: Germany
facility: Nycomed Deutschland GmbH
Study officials:
affiliation: Nycomed Deutschland GmbH, 78467 Konstanz, Germany
name: Dr. Thomas D. Bethke, MD, MBA
role: STUDY_DIRECTOR
References: