Lymph Node Resection
Conditions
Brief summary
The purpose of this study is to describe effectiveness and reliability of TachoSil® in lymph sealing after lymphadenectomy.
Detailed description
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.
Interventions
OTHERTachoSil®
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.
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Stationary patients undergoing lymph node resection.
Exclusion criteria
* Contraindications, such as hypersensitivity to the active pharmaceutical ingredient or to another ingredient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Post-Operative Seroma Formation Over Time as Determined at Hospital Discharge | Up to 50 Days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of TachoSil® by the Surgeon With Respect to Utility in Operation Using a 10-Point Numerical Rating Scale | Peri- and post-surgery (Up to 50 Days) | The surgeon evaluated Utility in Operation of TachoSil® using a 10-point scale where: 1=very useful to 10=completely useless. |
| Assessment of TachoSil® by the Surgeon With Respect to Satisfaction Using a 10-Point Numerical Rating Scale | Peri- and post-surgery (Up to 50 Days) | The surgeon evaluated Satisfaction in Operation of TachoSil® using a 10-point scale where: 1=very satisfied to 10=totally unsatisfied. |
| Percentage of Participants With at Least One Drainage Inserted | Baseline (Day of Surgery) | The total number of participants where at least one drainage was used during the operation. |
| Percentage of Participants With Change in Length of Drainage Stay and Drainage Volume | Up to 50 Days | — |
| Length of Hospital and ICU Stay | Up to 50 Days | Length of stay includes time (days) spent in the intensive care unit (ICU) and normal hospital station. |
| Assessment of TachoSil® by the Surgeon With Respect to Handling Using a 10-Point Numerical Rating Scale | Peri- and post-surgery (Up to 50 Days) | The surgeon evaluated handling of TachoSil® using a 10-point scale where: 1=very good to 10=very poor. |
| Percentage of Participants With Pharmacoeconomic Benefit Based on Shortening of Hospital Stay | Up to 50 Days | Pharmacoeconomic benefit was assessed by the surgeon at hospital discharge based on shortening of hospital stay in days. |
| Percentage of Participants With Pharmacoeconomic Benefit in Shortening of Time Spent in ICU | Up to 50 Days | Pharmacoeconomic benefit was assessed by the surgeon at hospital discharge based on shortening of time spent in ICU in days. |
| Percentage of Participants With Pharmacoeconomic Benefit Based on Drainage Time Reduced | Up to 50 Days | Pharmacoeconomic evaluation as assessed by the surgeon at hospital discharge based on drainage time reduced in days. |
| Percentage of Participants With Pharmacoeconomic Benefit Based on Drainage Volume Reduced | Up to 50 Days | Pharmacoeconomic benefit was assessed by the surgeon at hospital discharge based on the drainage volume reduced in milliliters. |
| Percentage of Participants With Post-Operative Complications and Adverse Events | Up to 50 Days | 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. |
| Percentage of Participants With Pharmacoeconomic Benefit Based on Savings of Operating Time | Peri- and post-surgery (Up to 50 Days) | Pharmacoeconomic benefit was assessed by the surgeon based on savings/shortening of operating time in minutes. |
Countries
Germany
Participant flow
Recruitment details
The study was conducted at 39 investigative sites in Germany from 30 September 2012 to 27 March 2014.
Pre-assignment details
Collection of information of routine use of TachoSil® in participants who had lymph node surgery.
Participants by arm
| Arm | Count |
|---|---|
| TachoSil® TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics. | 228 |
| Total | 228 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did Not Fulfill Inclusion Criteria | 5 |
Baseline characteristics
| Characteristic | TachoSil® |
|---|---|
| Age, Continuous | 63.6 years STANDARD_DEVIATION 10.82 |
| Body Mass Index (BMI) | 27.55 kg/m^2 STANDARD_DEVIATION 5.092 |
| Height | 169.9 cm STANDARD_DEVIATION 9.07 |
| Region of Enrollment Germany | 228 participants |
| Sex/Gender, Customized Female | 110 participants |
| Sex/Gender, Customized Male | 111 participants |
| Sex/Gender, Customized Missing | 7 participants |
| Weight | 79.6 kg STANDARD_DEVIATION 15.84 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 25 / 228 |
| serious Total, serious adverse events | 7 / 228 |
Outcome results
Primary
Percentage of Participants With Post-Operative Seroma Formation Over Time as Determined at Hospital Discharge
Time frame: Up to 50 Days
Population: Intent-to-treat population consisted of all participants who received patient information, signed consent and had Tachosil® applied during lymph node surgery.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TachoSil® | Percentage of Participants With Post-Operative Seroma Formation Over Time as Determined at Hospital Discharge | 2.63 percentage of participants |
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.
Time frame: Peri- and post-surgery (Up to 50 Days)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TachoSil® | Assessment of TachoSil® by the Surgeon With Respect to Handling Using a 10-Point Numerical Rating Scale | 2.2 score on a scale | Standard Deviation 0.98 |
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.
Time frame: Peri- and post-surgery (Up to 50 Days)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TachoSil® | Assessment of TachoSil® by the Surgeon With Respect to Satisfaction Using a 10-Point Numerical Rating Scale | 2.3 score on a scale | Standard Deviation 1.42 |
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.
Time frame: Peri- and post-surgery (Up to 50 Days)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TachoSil® | Assessment of TachoSil® by the Surgeon With Respect to Utility in Operation Using a 10-Point Numerical Rating Scale | 2.3 score on a scale | Standard Deviation 1.25 |
Secondary
Length of Hospital and ICU Stay
Length of stay includes time (days) spent in the intensive care unit (ICU) and normal hospital station.
Time frame: Up to 50 Days
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TachoSil® | Length of Hospital and ICU Stay | Hospital Stay (n=225) | 12.2 days | Standard Deviation 6.57 |
| TachoSil® | Length of Hospital and ICU Stay | ICU Stay (n=100) | 2.8 days | Standard Deviation 1.91 |
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.
Time frame: Baseline (Day of Surgery)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TachoSil® | Percentage of Participants With at Least One Drainage Inserted | 81.14 percentage of participants |
Secondary
Percentage of Participants With Change in Length of Drainage Stay and Drainage Volume
Time frame: Up to 50 Days
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TachoSil® | Percentage of Participants With Change in Length of Drainage Stay and Drainage Volume | Change in Length of Drainage Stay | 48.65 percentage of participants |
| TachoSil® | Percentage of Participants With Change in Length of Drainage Stay and Drainage Volume | Change in Drainage Volume | 57.84 percentage of participants |
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.
Time frame: Up to 50 Days
Population: 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®.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TachoSil® | Percentage of Participants With Pharmacoeconomic Benefit Based on Drainage Time Reduced | 35.96 percentage of participants |
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.
Time frame: Up to 50 Days
Population: 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®.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TachoSil® | Percentage of Participants With Pharmacoeconomic Benefit Based on Drainage Volume Reduced | 39.04 percentage of participants |
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.
Time frame: Peri- and post-surgery (Up to 50 Days)
Population: 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®.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TachoSil® | Percentage of Participants With Pharmacoeconomic Benefit Based on Savings of Operating Time | 17.98 percentage of participants |
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.
Time frame: Up to 50 Days
Population: 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®.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TachoSil® | Percentage of Participants With Pharmacoeconomic Benefit Based on Shortening of Hospital Stay | 27.19 percentage of participants |
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.
Time frame: Up to 50 Days
Population: 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®.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TachoSil® | Percentage of Participants With Pharmacoeconomic Benefit in Shortening of Time Spent in ICU | 8.77 percentage of participants |
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.
Time frame: Up to 50 Days
Population: 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®.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TachoSil® | Percentage of Participants With Post-Operative Complications and Adverse Events | Postoperative Complications | 18.42 percentage of participants |
| TachoSil® | Percentage of Participants With Post-Operative Complications and Adverse Events | Adverse Events | 13.60 percentage of participants |