Laparoscopy
Conditions
Keywords
minimal invasive surgery
Brief summary
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).
Detailed description
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.
Interventions
OTHERTachosil
TachoSil is a collagen matrix that is coated with human fibrinogen and human thrombin.
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
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
1. Has contraindications, such as hypersensitivity to the active pharmaceutical ingredients or to other components of pre-rolled TachoSil according to the current SmPC. 2. Is participating in another clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Investigators Assessment of Tachosil | Post-surgery until hospital discharge (up to 13 days) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Intra-surgery and post-surgery until hospital discharge (up to 13 days) | 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. |
| Number of Participants With Intra-operative and Post-operative Adverse Events (AEs) | Baseline up to 13 days | — |
Countries
Austria
Participant flow
Recruitment details
Participants took part in the study at 7 investigative sites in Austria from 05 April 2016 to 14 August 2017.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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. | 131 |
| Total | 131 |
Baseline characteristics
| Characteristic | TachoSil | — |
|---|---|---|
| Age, Customized 20-83 years | 131 participants | — |
| Participants With Height From 152 to 190 Centimeter (cm) | 131 Participants | — |
| Participants With Weight from 46.5 to 180 Kilogram (kg) | 131 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Austria | 131 participants | — |
| Sex: Female, Male Female | 81 Participants | — |
| Sex: Female, Male Male | 50 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 131 |
| other Total, other adverse events | 0 / 131 |
| serious Total, serious adverse events | 2 / 131 |
Outcome results
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.
Time frame: Post-surgery until hospital discharge (up to 13 days)
Population: The safety analysis set included all participants who were treated with TachoSil and completed the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TachoSil | Investigators Assessment of Tachosil | Overall satisfaction | 1.86 score on a scale | Standard Deviation 0.8 |
| TachoSil | Investigators Assessment of Tachosil | Overall manageability | 1.91 score on a scale | Standard Deviation 0.76 |
Secondary
Duration of Hospital Stay
Time frame: From date of surgery until hospital discharge (up to 13 days)
Population: The safety analysis set included all participants who were treated with TachoSil and completed the study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TachoSil | Duration of Hospital Stay | 5 days |
Secondary
Number of Participants With Intra-operative and Post-operative Adverse Events (AEs)
Time frame: Baseline up to 13 days
Population: The safety analysis set included all participants who were treated with TachoSil and completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TachoSil | Number of Participants With Intra-operative and Post-operative Adverse Events (AEs) | 2 participants |
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.
Time frame: Intra-surgery and post-surgery until hospital discharge (up to 13 days)
Population: The safety analysis set included all participants who were treated with TachoSil and completed the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TachoSil | Number of Participants With Pharmaco-economic Evaluation Based on Surgeon's Assessment | Participants with reduction of surgery time | 10 participants |
| TachoSil | Number of Participants With Pharmaco-economic Evaluation Based on Surgeon's Assessment | Participants with reduction of ICU time | 0 participants |
| TachoSil | Number of Participants With Pharmaco-economic Evaluation Based on Surgeon's Assessment | Participants with reduction of total care time | 0 participants |
| TachoSil | Number of Participants With Pharmaco-economic Evaluation Based on Surgeon's Assessment | Participants with other advantages | 8 participants |