LaparoscopyNCT02685007
RollOut -Pre-Rolled TachoSil in Laparoscopic Utilisation. A Non-Interventional Study
An observational study of Laparoscopy, run by Takeda at 8 sites in Austria.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laparoscopy
- What is being tested?
- Tachosil
- How many people
- 131 participants
- Where
- 8 sitesAustria
- Study dates
- 5 Apr 2016to 14 Aug 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- Has contraindications, such as hypersensitivity to the active pharmaceutical ingredients or to other components of pre-rolled TachoSil according to the current SmPC.
- Is participating in another clinical trial.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Austria8 sites
Landeskrankenhaus Hochsteiermark, Standort Bruck a.d. Mur; Abteilung fur Chirurgie
Bruck an der Mur
LKH Universitatsklinikum Graz Universitatklinik fur Chirurgie; Abteilung fur Allgemeinchirurgie
Graz
Landeskrankenhaus Hall; Allgemeine Chirurgie
Hall in Tirol
Kepler Universitatsklinikum GmbH Med Campus III.; Abteilung Chirurgie II
Linz
Krankenhaus der Barmherzigen Schwestern Linz Betriebsges.m.b.H
Linz
Landeskrankenhaus Salzburg/SALK Universitatsklinikum der PMU; Univ.-Klinik fur Urologie und Andrologie
Salzburg
Univ.-Klinik fur Chirurgie; Klin. Abt. fur Allgemeinchirurgie
Vienna
Klinikum Wels-Grieskirchen GmbH; Abteilung fur Urologie
Wels
About this study
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).
Read the 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.
- Conditions
- Laparoscopy
- Being tested
- Tachosil
- Keywords
- minimal invasive surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TachosilOther
TachoSil is a collagen matrix that is coated with human fibrinogen and human thrombin.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Tachosil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post-surgery until hospital discharge (up to 13 days)
Secondary outcomes (3)
Duration of Hospital Stay
Measured: 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.
Measured: Intra-surgery and post-surgery until hospital discharge (up to 13 days)
Number of Participants With Intra-operative and Post-operative Adverse Events (AEs)
Measured: Baseline up to 13 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2016 (estimated)
- Study start5 Apr 2016
- Primary completion14 Aug 2017
- Study completion14 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LaparoscopyStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02685007
- Sponsor's protocol ID
- TachoSil-4001
- Other IDs
- NIS005460
- Status last verified
- Mar 2020
- First submitted
- 8 Feb 2016
- Last updated
- 19 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RollOut -Pre-Rolled TachoSil in Laparoscopic Utilisation. A Non-Interventional Study
- ClinicalTrials.gov ID
- NCT02685007
- Acronym / sponsor ID
- TachoSil-4001
- Conditions
- Laparoscopy
- Keywords
- minimal invasive surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 5 Apr 2016 (actual)
- Primary completion
- 14 Aug 2017 (actual)
- Study completion
- 14 Aug 2017 (actual)
- First posted
- 18 Feb 2016 (estimated)
- Results
- Posted 19 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inpatients | – | Other: TachosilInpatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Has contraindications, such as hypersensitivity to the active pharmaceutical ingredients or to other components of pre-rolled TachoSil according to the current SmPC.
- Is participating in another clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TachosilTachoSil is a collagen matrix that is coated with human fibrinogen and human thrombin. | Other | Inpatients |
Primary outcome
Investigators Assessment of Tachosil
Time frame: 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.
3 secondary outcomes
Duration of Hospital Stay
Time frame: From date of surgery until hospital discharge (up to 13 days)
Number of Participants With Pharmaco-economic Evaluation Based on Surgeon's Assessment
Time frame: Intra-surgery and post-surgery until hospital discharge (up to 13 days)
Number of Participants With Intra-operative and Post-operative Adverse Events (AEs)
Time frame: Baseline up to 13 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Takeda
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laparoscopy, run by Takeda at 8 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigators Assessment of Tachosil (time frame: Post-surgery until hospital discharge (up to 13 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2020.