Use of Tachosil® for Lymph Sealing During Surgery

Study Overview
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Brief Summary
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The purpose of this study is to describe effectiveness and reliability of TachoSil® in lymph sealing after lymphadenectomy.

Detailed Description
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The aim of this non-interventional study (NIS) was to collect further knowledge on the routine use of TachoSil ® in lymph node surgery where its sealing property helps to reduce the rate of postoperative complications, especially of seroma formation. Some data are already available from gynecology, urology and thoracic surgery.

Official Title
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Use of Tachosil® for Lymph Sealing During Surgery. A Non-Interventional Study

Conditions
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Lymph Node Resection

Intervention / Treatment
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* Other: TachoSil®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stationary patients undergoing lymph node resection. Exclusion Criteria: Contraindications, such as hypersensitivity to the active pharmaceutical ingredient or to another ingredient.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TachoSil®<br>TachoSil®, sterile absorbable patch, topical application, used during surgery in participants who had lymphadenectomy according to the Summary of Product Characteristics. | Other: TachoSil®<br>* TachoSil® is a collagen sponge that is coated with the active substances human fibrinogen and human thrombin and that supports hemostasis and tissue sealing in surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Post-Operative Seroma Formation Over Time as Determined at Hospital Discharge |  | Up to 50 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of TachoSil® by the Surgeon With Respect to Handling Using a 10-Point Numerical Rating Scale | The surgeon evaluated handling of TachoSil® using a 10-point scale where: 1=very good to 10=very poor. | Peri- and post-surgery (Up to 50 Days) | 
| Assessment of TachoSil® by the Surgeon With Respect to Utility in Operation Using a 10-Point Numerical Rating Scale | The surgeon evaluated Utility in Operation of TachoSil® using a 10-point scale where: 1=very useful to 10=completely useless. | Peri- and post-surgery (Up to 50 Days) | 
| Assessment of TachoSil® by the Surgeon With Respect to Satisfaction Using a 10-Point Numerical Rating Scale | The surgeon evaluated Satisfaction in Operation of TachoSil® using a 10-point scale where: 1=very satisfied to 10=totally unsatisfied. | Peri- and post-surgery (Up to 50 Days) | 
| Percentage of Participants With at Least One Drainage Inserted | The total number of participants where at least one drainage was used during the operation. | Baseline (Day of Surgery) | 
| Percentage of Participants With Change in Length of Drainage Stay and Drainage Volume |  | Up to 50 Days | 
| Length of Hospital and ICU Stay | Length of stay includes time (days) spent in the intensive care unit (ICU) and normal hospital station. | Up to 50 Days | 
| Percentage of Participants With Pharmacoeconomic Benefit Based on Savings of Operating Time | Pharmacoeconomic benefit was assessed by the surgeon based on savings/shortening of operating time in minutes. | Peri- and post-surgery (Up to 50 Days) | 
| Percentage of Participants With Pharmacoeconomic Benefit Based on Shortening of Hospital Stay | Pharmacoeconomic benefit was assessed by the surgeon at hospital discharge based on shortening of hospital stay in days. | Up to 50 Days | 
| Percentage of Participants With Pharmacoeconomic Benefit in Shortening of Time Spent in ICU | Pharmacoeconomic benefit was assessed by the surgeon at hospital discharge based on shortening of time spent in ICU in days. | Up to 50 Days | 
| Percentage of Participants With Pharmacoeconomic Benefit Based on Drainage Time Reduced | Pharmacoeconomic evaluation as assessed by the surgeon at hospital discharge based on drainage time reduced in days. | Up to 50 Days | 
| Percentage of Participants With Pharmacoeconomic Benefit Based on Drainage Volume Reduced | Pharmacoeconomic benefit was assessed by the surgeon at hospital discharge based on the drainage volume reduced in milliliters. | Up to 50 Days | 
| Percentage of Participants With Post-Operative Complications and Adverse Events | An Adverse Event (AE) is defined as any untoward medical occurrence in a participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. | Up to 50 Days |