Non-Interventional Study About Treatment of Hemorrhages in Thyroid Surgery With TachoSil®
Completed
- Conditions
- Hemorrhage
- Registration Number
- NCT00700141
- Lead Sponsor
- Nycomed
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 482
Inclusion Criteria
- Patients undergoing total or subtotal thyroidectomy
Main
Exclusion Criteria
- Contraindications, such as hypersensitivity to the active pharmaceutical ingredient or to another ingredient
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of TachoSil® by the Surgeon With Respect to Handling, Utility and Satisfaction in the Operation, Documented Using 10 Point Numerical Rating Scales 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
Name Time Method Pharmacoeconomic Benefits as Assessed by the Surgeon 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)
Trial Locations
- Locations (1)
Nycomed Deutschland GmbH
🇩🇪Würzburg, Germany