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

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.

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Key information

Conditions

Hemorrhage Endocrine System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Thyroid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nycomed Deutschland GmbH, Aschaffenburg, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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 outcomes

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)

Sponsors and collaborators

Lead sponsor

Nycomed

Industry

Registry information

Official study title

Non-Interventional Study on the Use of TachoSil® During Thyroid Surgery

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Jun 18, 2008
Registry last updated: May 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed