Non-Interventional Study About Treatment of Hemorrhages in Thyroid Surgery With TachoSil®

NCT00700141 | Completed Results

• 1 other identifier: TC-031-DE
• Study Type: observational
• Target: 482
• Locations: 1 country
• Sites: 132

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.

Conditions

Hemorrhage

Keywords

Tachosil; thyroid; parathyroid; fleece-bound hemostasispathologic processes; hemorrhage; thyroid surgery

Outcome Measures

Primary Outcomes (1)

• Assessment of TachoSil® by the Surgeon With Respect to Handling, Utility and Satisfaction in the Operation, Documented Using 10 Point Numerical Rating Scales

  Handling (1= very good to 10= very poor) Satisfaction (1= very satisfied to 10= totally unsatisfied) Utility (1= very useful to 10= completely useless)

  after surgery

Secondary Outcomes (1)

• Pharmacoeconomic Benefits as Assessed by the Surgeon

  peri- and post-surgery until hospital discharge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Inpatients

You may qualify if:

• Patients undergoing total or subtotal thyroidectomy

You may not qualify if:

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

Sponsors & Collaborators

• Nycomed: lead

Study Sites (132)

Nycomed Deutschland GmbH

Aschaffenburg, 63739, Germany

Location

Nycomed Deutschland GmbH

Aschersleben, 06449, Germany

Location

Nycomed Deutschland GmbH

Bad Berka, 99437, Germany

Location

Nycomed Deutschland GmbH

Bad Salzungen, 36433, Germany

Location

Nycomed Deutschland GmbH

Bad Tölz, 83646, Germany

Location

Nycomed Deutschland GmbH

Baden-Baden, 76532, Germany

Location

Nycomed Deutschland GmbH

Bayreuth, 95445, Germany

Location

Nycomed Deutschland GmbH

Berlin, 10117, Germany

Location

Nycomed Deutschland GmbH

Berlin, 10365, Germany

Location

Nycomed Deutschland GmbH

Berlin, 12157, Germany

Location

Nycomed Deutschland GmbH

Berlin, 12559, Germany

Location

Nycomed Deutschland GmbH

Berlin, 14193, Germany

Location

Nycomed Deutschland GmbH

Bielefeld, 33604, Germany

Location

Nycomed Deutschland GmbH

Bielefeld, 33611, Germany

Location

Nycomed Deutschland GmbH

Bischofswerda, 01877, Germany

Location

Nycomed Deutschland GmbH

Bochum, 44791, Germany

Location

Nycomed Deutschland GmbH

Bonn, 53115, Germany

Location

Nycomed Deutschland GmbH

Bottrop, 46242, Germany

Location

Nycomed Deutschland GmbH

Braunschweig, 38124, Germany

Location

Nycomed Deutschland GmbH

Bruchsal, 76646, Germany

Location

Nycomed Deutschland GmbH

Chemnitz, 09116, Germany

Location

Nycomed Deutschland GmbH

Cologne, 50733, Germany

Location

Nycomed Deutschland GmbH

Coswig, 01640, Germany

Location

Nycomed Deutschland GmbH

Cottbus, 03048, Germany

Location

Nycomed Deutschland GmbH

Deggendorf, 94469, Germany

Location

Nycomed Deutschland GmbH

Detmold, 32756, Germany

Location

Nycomed Deutschland GmbH

Dinkelsbühl, 91550, Germany

Location

Nycomed Deutschland GmbH

Dortmund, 44137, Germany

Location

Nycomed Deutschland GmbH

Duisburg, 47001, Germany

Location

Nycomed Deutschland GmbH

Düsseldorf, 40225, Germany

Location

Nycomed Deutschland GmbH

Düsseldorf, 40489, Germany

Location

Nycomed Deutschland GmbH

Düsseldorf, 40549, Germany

Location

Nycomed Deutschland GmbH

Eberswalde, 16225, Germany

Location

Nycomed Deutschland GmbH

Eckernförde, 24340, Germany

Location

Nycomed Deutschland GmbH

Eichsfeld, 37355, Germany

Location

Nycomed Deutschland GmbH

Eisenach, 99817, Germany

Location

Nycomed Deutschland GmbH

Erfurt, 99097, Germany

Location

Nycomed Deutschland GmbH

Erlangen, 91054, Germany

Location

Nycomed Deutschland GmbH

Essen, 45136, Germany

Location

Nycomed Deutschland GmbH

Essen, 45329, Germany

Location

Nycomed Deutschland GmbH

Frankfurt, 60318, Germany

Location

Nycomed Deutschland GmbH

Frankfurt (Oder), 15236, Germany

Location

Nycomed Deutschland GmbH

Frechen, 50226, Germany

Location

Nycomed Deutschland GmbH

Freudenstadt, 72233, Germany

Location

Nycomed Deutschland GmbH

Fürstenfeldbruck, 82256, Germany

Location

Nycomed Deutschland GmbH

Fürth, 90766, Germany

Location

Nycomed Deutschland GmbH

Gelnhausen, 63571, Germany

Location

Nycomed Deutschland GmbH

Gelsenkirchen, 45894, Germany

Location

Nycomed Deutschland GmbH

Gera, 07548, Germany

Location

Nycomed Deutschland GmbH

Göppingen, 73035, Germany

Location

Nycomed Deutschland GmbH

Görlitz, 02828, Germany

Location

Nycomed Deutschland GmbH

Gummersbach, 51643, Germany

Location

Nycomed Deutschland GmbH

Hagen, 58097, Germany

Location

Nycomed Deutschland GmbH

Halle, 06120, Germany

Location

Nycomed Deutschland GmbH

Hamburg, 20099, Germany

Location

Nycomed Deutschland GmbH

Hamburg, 22043, Germany

Location

Nycomed Deutschland GmbH

Hamburg, 22087, Germany

Location

Nycomed Deutschland GmbH

Hamburg, 22359, Germany

Location

Nycomed Deutschland GmbH

Hamburg, 22417, Germany

Location

Nycomed Deutschland GmbH

Hamm, 59073, Germany

Location

Nycomed Deutschland GmbH

Hanau, 63450, Germany

Location

Nycomed Deutschland GmbH

Hartmannsdorf, 09232, Germany

Location

Nycomed Deutschland GmbH

Hausham, 83734, Germany

Location

Nycomed Deutschland GmbH

Heilbronn, 74064, Germany

Location

Nycomed Deutschland GmbH

Heinsberg, 52525, Germany

Location

Nycomed Deutschland GmbH

Herten, 45697, Germany

Location

Nycomed Deutschland GmbH

Ibbenbueren, 49477, Germany

Location

Nycomed Deutschland GmbH

Ingolstadt, 85049, Germany

Location

Nycomed Deutschland GmbH

Jena, 07747, Germany

Location

Nycomed Deutschland GmbH

Karlsruhe, 76137, Germany

Location

Nycomed Deutschland GmbH

Karlsruhe, 76199, Germany

Location

Nycomed Deutschland GmbH

Kassel, 34121, Germany

Location

Nycomed Deutschland GmbH

Kassel, 34127, Germany

Location

Nycomed Deutschland GmbH

Konstanz, 78464, Germany

Location

Nycomed Deutschland GmbH

Köln-Lindenthal, 50931, Germany

Location

Nycomed Deutschland GmbH

Langen, 63225, Germany

Location

Nycomed Deutschland GmbH

Leipzig, 04129, Germany

Location

Nycomed Deutschland GmbH

Leipzig, 04289, Germany

Location

Nycomed Deutschland GmbH

Lichtenfels, 96215, Germany

Location

Nycomed Deutschland GmbH

Loerrach, 79539, Germany

Location

Nycomed Deutschland GmbH

Lohr a. Main, 97816, Germany

Location

Nycomed Deutschland GmbH

Luckenwalde, 14943, Germany

Location

Nycomed Deutschland GmbH

Lübbecke, 32312, Germany

Location

Nycomed Deutschland GmbH

Lübeck, 23560, Germany

Location

Nycomed Deutschland GmbH

Magdeburg, 39130, Germany

Location

Nycomed Deutschland GmbH

Mainz, 55101, Germany

Location

Nycomed Deutschland GmbH

Mainz, 55131, Germany

Location

Nycomed Deutschland GmbH

Mannheim, 68163, Germany

Location

Nycomed Deutschland GmbH

Mannheim, 68167, Germany

Location

Nycomed Deutschland GmbH

Marburg, 35033, Germany

Location

Nycomed Deutschland GmbH

Meppen, 49716, Germany

Location

Nycomed Deutschland GmbH

Mettmann, 40822, Germany

Location

Nycomed Deutschland GmbH

München, 80638, Germany

Location

Nycomed Deutschland GmbH

Münster, 48143, Germany

Location

Nycomed Deutschland GmbH

Münster, 48153, Germany

Location

Nycomed Deutschland GmbH

Neu-Ulm, 89231, Germany

Location

Nycomed Deutschland GmbH

Neumarkt in der Oberpfalz, 92318, Germany

Location

Nycomed Deutschland GmbH

Neumünster, 24535, Germany

Location

Nycomed Deutschland GmbH

Neuruppin, 16816, Germany

Location

Nycomed Deutschland GmbH

Nordhausen, 99734, Germany

Location

Nycomed Deutschland GmbH

Nuremberg, 90491, Germany

Location

Nycomed Deutschland GmbH

Oberhausen, 46145, Germany

Location

Nycomed Deutschland GmbH

Oldenburg, 26121, Germany

Location

Nycomed Deutschland GmbH

Oldenburg, 26133, Germany

Location

Nycomed Deutschland GmbH

Pforzheim, 75175, Germany

Location

Nycomed Deutschland GmbH

Potsdam, 14467, Germany

Location

Nycomed Deutschland GmbH

Prien am Chiemsee, 83209, Germany

Location

Nycomed Deutschland GmbH

Radebeul, 01554, Germany

Location

Nycomed Deutschland GmbH

Rathenow, 14712, Germany

Location

Nycomed Deutschland GmbH

Recklinghausen, 45657, Germany

Location

Nycomed Deutschland GmbH

Regensburg, 93042, Germany

Location

Nycomed Deutschland GmbH

Regensburg, 93053, Germany

Location

Nycomed Deutschland GmbH

Rheda-Wiedenbrück, 33378, Germany

Location

Nycomed Deutschland GmbH

Rosenheim, 83022, Germany

Location

Nycomed Deutschland GmbH

Rostock, 18055, Germany

Location

Nycomed Deutschland GmbH

Sangerhausen, 06526, Germany

Location

Nycomed Deutschland GmbH

Schwedt, 16303, Germany

Location

Nycomed Deutschland GmbH

Schweinfurth, 97421, Germany

Location

Nycomed Deutschland GmbH

Singen, 78221, Germany

Location

Nycomed Deutschland GmbH

Solingen, 42653, Germany

Location

Nycomed Deutschland GmbH

Stuttgart, 70199, Germany

Location

Nycomed Deutschland GmbH

Traunstein, 83278, Germany

Location

Nycomed Deutschland GmbH

Trostberg an der Alz, 83308, Germany

Location

Nycomed Deutschland GmbH

Ulm, 89073, Germany

Location

Nycomed Deutschland GmbH

Ulm, 89081, Germany

Location

Nycomed Deutschland GmbH

Weimar, 99425, Germany

Location

Nycomed Deutschland GmbH

Weißenfels, 06667, Germany

Location

Nycomed Deutschland GmbH

Wiesbaden, 65189, Germany

Location

Nycomed Deutschland GmbH

Wiesbaden, 65199, Germany

Location

Nycomed Deutschland GmbH

Wipperfürth, 51688, Germany

Location

Nycomed Deutschland GmbH

Wismar, 23966, Germany

Location

Nycomed Deutschland GmbH

Würzburg, 97080, Germany

Location

MeSH Terms

Conditions

Hemorrhage; Thyroid Diseases

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Endocrine System Diseases

Results Point of Contact

• Title: Medical Responsible
• Organization: Nycomed Deutschland GmbH

clinicaltrials@nycomed.com

+49 7531 3666 0

Study Officials

• Dr. Thomas D. Bethke, MD, MBA

  Nycomed Deutschland GmbH, 78467 Konstanz, Germany

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 17, 2008
• First Posted: June 18, 2008
• Study Start: September 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: May 8, 2012
• Results First Posted: April 6, 2010

Record last verified: 2010-04

Locations

DE (132)