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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00700141
Recruitment Status : Completed
First Posted : June 18, 2008
Results First Posted : April 6, 2010
Last Update Posted : May 8, 2012
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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.

Condition or disease

Study Type : Observational
Actual Enrollment : 482 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-Interventional Study on the Use of TachoSil® During Thyroid Surgery
Study Start Date : September 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

Drug Information available for: TachoSil

Primary Outcome Measures :
  1. Assessment of TachoSil® by the Surgeon With Respect to Handling, Utility and Satisfaction in the Operation, Documented Using 10 Point Numerical Rating Scales [ Time Frame: after surgery ]
    Handling (1= very good to 10= very poor) Satisfaction (1= very satisfied to 10= totally unsatisfied) Utility (1= very useful to 10= completely useless)

Secondary Outcome Measures :
  1. Pharmacoeconomic Benefits as Assessed by the Surgeon [ Time Frame: peri- and post-surgery until hospital discharge ]
    Question: What benefits resulted from the application of TachoSil® during this operation? (different categories to be answered with yes/no)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00700141

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Sponsors and Collaborators
Study Director: Dr. Thomas D. Bethke, MD, MBA Nycomed Deutschland GmbH, 78467 Konstanz, Germany

Responsible Party: Medical Responsible, Nycomed Deutschland GmbH Identifier: NCT00700141     History of Changes
Other Study ID Numbers: TC-031-DE
First Posted: June 18, 2008    Key Record Dates
Results First Posted: April 6, 2010
Last Update Posted: May 8, 2012
Last Verified: April 2010

Keywords provided by Nycomed:
fleece-bound hemostasispathologic processes
thyroid surgery

Additional relevant MeSH terms:
Pathologic Processes