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| ID | Type | Description | Link |
|---|---|---|---|
| NIS005460 | Registry Identifier | AGES |
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The purpose of this study is to describe ease of use and satisfaction with application of the pre-rolled TachoSil in laparoscopic procedures within approved therapeutic indication as per Summary of Product Characteristics (SmPC).
The drug being observed in this study is called Tachosil. Tachosil is being used in open invasive surgery for use as a local haemostatic and tissue sealing. This study will look at the application and an overview on the ease of use of pre-rolled form of Tachosil in minimal invasive (laparoscopic) surgery, cost analysis along with the evaluation of participant's satisfaction with the product.
The study will enroll approximately 131 participants who will be inpatients. A participant can be included in the study when the physician has decided to use pre-rolled TachoSil according to the local SmPC and after obtaining informed consent from the participant. Participants will be analyzed in a routine setting after surgery.
Data from all participants will be collected from their files as well as study specific questions answered by the treating physician.
This multi-center trial will be conducted in 7 Austrian centers. The overall recruitment period is expected for 1 year and six months. Participants will be analyzed from the date of surgery till their discharge from hospital.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inpatients | Inpatients planned for laparoscopic surgery, in the field of gynecology, urology and visceral surgery will be documented from of surgery until date of discharge from hospital |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tachosil | Other | TachoSil is a collagen matrix that is coated with human fibrinogen and human thrombin. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Investigators Assessment of Tachosil | Investigators were asked to evaluate the overall manageability and satisfaction with TachoSil in laparoscopic surgery. The overall manageability and satisfaction of TachoSil application was assessed using Likert scale. It is a 5-point scale, that ranges from 1-5, where 1=easy to use/satisfied to 5=difficult to use/not satisfied. Higher scores indicates difficulty and less satisfaction. The mean manageability satisfaction with the application of TachoSil were reported. | Post-surgery until hospital discharge (up to 13 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Hospital Stay | From date of surgery until hospital discharge (up to 13 days) | |
| Number of Participants With Pharmaco-economic Evaluation Based on Surgeon's Assessment | Pharmaco-economic evaluation based on surgeon's assessment included surgery time, intensive care unit (ICU) time, total care time, and other advantages. Other advantages included reduced or no risk of secondary bleeding, and the easier application and manageability. |
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Inclusion Criteria:
1- Inpatients planned for laparoscopic surgery, in the field of gynecology, urology and abdominal surgery where pre-rolled TachoSil was applied, 18 years or older.
Exclusion Criteria:
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Study population will include inpatients planned for laparoscopic surgery, in the field of gynecology, urology and visceral surgery and where pre-rolled TachoSil will be applied.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Landeskrankenhaus Hochsteiermark, Standort Bruck a.d. Mur; Abteilung fur Chirurgie | Bruck an der Mur | Austria | ||||
Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
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Participants planned for laparoscopic surgery in the field of gynecology, urology or visceral surgery were enrolled in this study to use pre-rolled TachoSil according to the local Summary of Product Characteristics (SmPC) based on physician decision and the data was collected under routine standard of care.
Participants took part in the study at 7 investigative sites in Austria from 05 April 2016 to 14 August 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | TachoSil | TachoSil, sealant matrix coated with fibrinogen and thrombin, epilesional application, applied during surgery in participants who had laparoscopic surgery, in the field of gynecology, urology and visceral surgery according to the local SmPC. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The safety analysis set included all participants who were treated with TachoSil and completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | TachoSil | TachoSil, sealant matrix coated with fibrinogen and thrombin, epilesional application, applied during surgery in participants who had laparoscopic surgery, in the field of gynecology, urology and visceral surgery according to the local SmPC. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Investigators Assessment of Tachosil | Investigators were asked to evaluate the overall manageability and satisfaction with TachoSil in laparoscopic surgery. The overall manageability and satisfaction of TachoSil application was assessed using Likert scale. It is a 5-point scale, that ranges from 1-5, where 1=easy to use/satisfied to 5=difficult to use/not satisfied. Higher scores indicates difficulty and less satisfaction. The mean manageability satisfaction with the application of TachoSil were reported. | The safety analysis set included all participants who were treated with TachoSil and completed the study. | Posted | Mean | Standard Deviation | score on a scale | Post-surgery until hospital discharge (up to 13 days) |
|
Treatment-emergent adverse events (TEAEs) are AEs that started after the first application of open label study drug up to end of study (up to 13 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, sealant matrix coated with fibrinogen and thrombin, epilesional application, applied during surgery in participants who had laparoscopic surgery, in the field of gynecology, urology and visceral surgery according to the local SmPC. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal incarcerated hernia | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 20, 2015 | Jul 30, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 15, 2017 | Jul 30, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C518955 | TachoSil |
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| Intra-surgery and post-surgery until hospital discharge (up to 13 days) |
| Number of Participants With Intra-operative and Post-operative Adverse Events (AEs) | Baseline up to 13 days |
| LKH Universitatsklinikum Graz Universitatklinik fur Chirurgie; Abteilung fur Allgemeinchirurgie |
| Graz |
| Austria |
| Landeskrankenhaus Hall; Allgemeine Chirurgie | Hall in Tirol | Austria |
| Kepler Universitatsklinikum GmbH Med Campus III.; Abteilung Chirurgie II | Linz | Austria |
| Krankenhaus der Barmherzigen Schwestern Linz Betriebsges.m.b.H | Linz | Austria |
| Landeskrankenhaus Salzburg/SALK Universitatsklinikum der PMU; Univ.-Klinik fur Urologie und Andrologie | Salzburg | Austria |
| Univ.-Klinik fur Chirurgie; Klin. Abt. fur Allgemeinchirurgie | Vienna | Austria |
| Klinikum Wels-Grieskirchen GmbH; Abteilung fur Urologie | Wels | Austria |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants With Height From 152 to 190 Centimeter (cm) | Count of Participants | Participants |
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| Participants With Weight from 46.5 to 180 Kilogram (kg) | Count of Participants | Participants |
|
|
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| Secondary | Duration of Hospital Stay | The safety analysis set included all participants who were treated with TachoSil and completed the study. | Posted | Median | Full Range | days | From date of surgery until hospital discharge (up to 13 days) |
|
|
|
| Secondary | Number of Participants With Pharmaco-economic Evaluation Based on Surgeon's Assessment | Pharmaco-economic evaluation based on surgeon's assessment included surgery time, intensive care unit (ICU) time, total care time, and other advantages. Other advantages included reduced or no risk of secondary bleeding, and the easier application and manageability. | The safety analysis set included all participants who were treated with TachoSil and completed the study. | Posted | Number | participants | Intra-surgery and post-surgery until hospital discharge (up to 13 days) |
|
|
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| Secondary | Number of Participants With Intra-operative and Post-operative Adverse Events (AEs) | The safety analysis set included all participants who were treated with TachoSil and completed the study. | Posted | Number | participants | Baseline up to 13 days |
|
|
|
| 0 |
| 131 |
| 2 |
| 131 |
| 0 |
| 131 |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
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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.
| Title | Measurements |
|---|---|
|
| Participants with other advantages |
|