N/A
N=482
Non-Interventional Study About Treatment of Hemorrhages in Thyroid Surgery With TachoSil®
Hemorrhage
Bottom Line
View on ClinicalTrials.gov: NCT00700141 ↗Enrolled (actual)
482
Serious AEs
0.0%
Results posted
Apr 2010
Primary outcome: Primary: Assessment of TachoSil® by the Surgeon With Respect to Handling, Utility and Satisfaction in the Operation, Documented Using 10 Point Numerical Rating Scales — 2.54; 2.25; 2.42 Units on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Nycomed
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assessment of TachoSil® by the Surgeon With Respect to Handling, Utility and Satisfaction in the Operation, Documented Using 10 Point Numerical Rating Scales |
2.54; 2.25; 2.42 | — |
| SECONDARY Pharmacoeconomic Benefits as Assessed by the Surgeon |
355; 286; 277; 83; 44; 30 | — |
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
Data sourced from ClinicalTrials.gov (NCT00700141). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.