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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1142-0279 | Registry Identifier | WHO |
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The purpose of this study is to describe effectiveness and reliability of TachoSil® in lymph sealing after lymphadenectomy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TachoSil® | TachoSil®, sterile absorbable patch, topical application, used during surgery in participants who had lymphadenectomy according to the Summary of Product Characteristics. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TachoSil® | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Post-Operative Seroma Formation Over Time as Determined at Hospital Discharge | Up to 50 Days |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Stationary patients in whom a lymph node resection was planned to be performed
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda Pharma Vertrieb GmbH & Co. KG | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Greifswald | Germany |
Collection of information of routine use of TachoSil® in participants who had lymph node surgery.
The study was conducted at 39 investigative sites in Germany from 30 September 2012 to 27 March 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | TachoSil® | TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
ITT population consisted of all patients who received patient information and who consented to the collection, transmission and evaluation of their data and who underwent lymph node resection with TachoSil®.
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| ID | Title | Description |
|---|---|---|
| BG000 | TachoSil® | TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age data was available for 226 participants. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Post-Operative Seroma Formation Over Time as Determined at Hospital Discharge | Intent-to-treat population consisted of all participants who received patient information, signed consent and had Tachosil® applied during lymph node surgery. | Posted | Number | percentage of participants | Up to 50 Days |
|
|
Up to 30 days
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TachoSil® | TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Groin abscess | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphocele | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director, Clinical Science | Takeda | +1-877-825-3327 | clinicaltrialregistry@tpna.com |
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| ID | Term |
|---|---|
| C518955 | TachoSil |
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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 |
| Mean |
| Standard Deviation |
| years |
|
| Sex/Gender, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Height data was available for 216 participants. | Mean | Standard Deviation | cm |
|
| Weight | Weight data was available for 216 participants. | Mean | Standard Deviation | kg |
|
| Body Mass Index (BMI) | BMI data was available for 216 participants. | Mean | Standard Deviation | kg/m^2 |
|
|
|
| Secondary | 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. | Participants from the Intent-to-treat population (all participants who received patient information, signed consent and had Tachosil® applied during lymph node surgery) with data available for analysis. | Posted | Mean | Standard Deviation | score on a scale | Peri- and post-surgery (Up to 50 Days) |
|
|
|
| Secondary | 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. | Participants from the Intent-to-treat population (all participants who received patient information, signed consent and had Tachosil® applied during lymph node surgery) with data available for analysis. | Posted | Mean | Standard Deviation | score on a scale | Peri- and post-surgery (Up to 50 Days) |
|
|
|
| Secondary | 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. | Participants from the Intent-to-treat population (all participants who received patient information, signed consent and had Tachosil® applied during lymph node surgery) with data available for analysis. | Posted | Mean | Standard Deviation | score on a scale | Peri- and post-surgery (Up to 50 Days) |
|
|
|
| Secondary | Percentage of Participants With at Least One Drainage Inserted | The total number of participants where at least one drainage was used during the operation. | Participants from the Intent-to-treat population (all participants who received patient information, signed consent and had Tachosil® applied during lymph node surgery) with data available for analysis. | Posted | Number | percentage of participants | Baseline (Day of Surgery) |
|
|
|
| Secondary | Percentage of Participants With Change in Length of Drainage Stay and Drainage Volume | Participants from the Intent-to-treat population (all participants who received patient information, signed consent and had Tachosil® applied during lymph node surgery) with data available for analysis. | Posted | Number | percentage of participants | Up to 50 Days |
|
|
|
| Secondary | Length of Hospital and ICU Stay | Length of stay includes time (days) spent in the intensive care unit (ICU) and normal hospital station. | Participants from the Intent-to-treat population (all participants who received patient information, signed consent and had Tachosil® applied during lymph node surgery) with data available for analysis. | Posted | Mean | Standard Deviation | days | Up to 50 Days |
|
|
|
| Secondary | 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. | ITT population consisted of all patients who received patient information and consented to the collection, transmission and evaluation of their data and who underwent lymph node resection with TachoSil®. | Posted | Number | percentage of participants | Peri- and post-surgery (Up to 50 Days) |
|
|
|
| Secondary | 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. | ITT population consisted of all patients who received patient information and consented to the collection, transmission and evaluation of their data and who underwent lymph node resection with TachoSil®. | Posted | Number | percentage of participants | Up to 50 Days |
|
|
|
| Secondary | 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. | ITT population consisted of all patients who received patient information and consented to the collection, transmission and evaluation of their data and who underwent lymph node resection with TachoSil®. | Posted | Number | percentage of participants | Up to 50 Days |
|
|
|
| Secondary | 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. | ITT population consisted of all patients who received patient information and consented to the collection, transmission and evaluation of their data and who underwent lymph node resection with TachoSil®. | Posted | Number | percentage of participants | Up to 50 Days |
|
|
|
| Secondary | 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. | ITT population consisted of all patients who received patient information and consented to the collection, transmission and evaluation of their data and who underwent lymph node resection with TachoSil®. | Posted | Number | percentage of participants | Up to 50 Days |
|
|
|
| Secondary | 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. | ITT population consisted of all patients who received patient information and consented to the collection, transmission and evaluation of their data and who underwent lymph node resection with TachoSil®. | Posted | Number | percentage of participants | Up to 50 Days |
|
|
|
| 7 |
| 228 |
| 25 |
| 228 |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Seroma | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Lymphocele | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
|
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.