Hemorrhage
Conditions
Keywords
Tachosil, thyroid, parathyroid, fleece-bound hemostasispathologic processes, hemorrhage, thyroid surgery
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.
Interventions
None listed
Sponsors
Nycomed
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TachoSil® Application Patients with application of at least one fleece of TachoSil® during thyroid surgery | 482 |
| Total | 482 |
Baseline characteristics
| Characteristic | TachoSil® Application |
|---|---|
| Age Continuous between 15 and 91 years | 53.33 years STANDARD_DEVIATION 14.39 |
| Number of Participants with the Indicated Hemorrhagic Risk Present Application of medicines affecting coagulation | 96 participants |
| Number of Participants with the Indicated Hemorrhagic Risk Present Disturbance of the thrombocyte hemostasis | 9 participants |
| Number of Participants with the Indicated Hemorrhagic Risk Present Hereditary coagulation disorders | 4 participants |
| Number of Participants with the Indicated Hemorrhagic Risk Present Hyperparathyroidism | 80 participants |
| Number of Participants with the Indicated Hemorrhagic Risk Present Liver function disorders | 3 participants |
| Number of Participants with the Indicated Hemorrhagic Risk Present Other risks (M.Basedow, thyroiditis, tumor) | 47 participants |
| Sex: Female, Male Female | 343 Participants |
| Sex: Female, Male Male | 139 Participants |
| Type of surgery 1-ST | 25 participants |
| Type of surgery 2-ST | 82 participants |
| Type of surgery Enuc | 5 participants |
| Type of surgery HT | 83 participants |
| Type of surgery HT+ST | 70 participants |
| Type of surgery TE | 217 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 482 |
| serious Total, serious adverse events | 0 / 482 |
Outcome results
Primary
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)
Time frame: after surgery
Population: All 482 patients included and treated with TachoSil® \[= Intention to Treat population (ITT)\], missing values not imputed.~For one patient missing information in all three scales (Handling, Utility and Satisfaction in the Operation)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TachoSil® Application | Assessment of TachoSil® by the Surgeon With Respect to Handling, Utility and Satisfaction in the Operation, Documented Using 10 Point Numerical Rating Scales | Handling | 2.54 Units on a scale | Standard Deviation 1.52 |
| TachoSil® Application | Assessment of TachoSil® by the Surgeon With Respect to Handling, Utility and Satisfaction in the Operation, Documented Using 10 Point Numerical Rating Scales | Satisfaction | 2.25 Units on a scale | Standard Deviation 1.8 |
| TachoSil® Application | Assessment of TachoSil® by the Surgeon With Respect to Handling, Utility and Satisfaction in the Operation, Documented Using 10 Point Numerical Rating Scales | Utility | 2.42 Units on a scale | Standard Deviation 1.63 |
Secondary
Pharmacoeconomic Benefits as Assessed by the Surgeon
Question: What benefits resulted from the application of TachoSil® during this operation? (different categories to be answered with yes/no)
Time frame: peri- and post-surgery until hospital discharge
Population: All 482 patients included and treated with TachoSil®, missing values not imputed.~Multiple answers possible.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TachoSil® Application | Pharmacoeconomic Benefits as Assessed by the Surgeon | Nerve sparing through atraumatic procedure | 355 participants |
| TachoSil® Application | Pharmacoeconomic Benefits as Assessed by the Surgeon | Saving/Shortening of operation time | 286 participants |
| TachoSil® Application | Pharmacoeconomic Benefits as Assessed by the Surgeon | Reduced probability of postoperative complications | 277 participants |
| TachoSil® Application | Pharmacoeconomic Benefits as Assessed by the Surgeon | Reduced time in overall length of hospital stay | 83 participants |
| TachoSil® Application | Pharmacoeconomic Benefits as Assessed by the Surgeon | Saving of erythrocyte concentrates | 44 participants |
| TachoSil® Application | Pharmacoeconomic Benefits as Assessed by the Surgeon | Saving of thrombocyte concentrates | 30 participants |
| TachoSil® Application | Pharmacoeconomic Benefits as Assessed by the Surgeon | Reduced time in intensive care unit | 27 participants |
| TachoSil® Application | Pharmacoeconomic Benefits as Assessed by the Surgeon | Saving of Fresh Frozen Plasma (FFP) | 26 participants |