RollOut -Pre-Rolled TachoSil in Laparoscopic Utilisation. A Non-Interventional Study
2 other identifiers
observational
131
1 country
8
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2016
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 8, 2016
CompletedFirst Posted
Study publicly available on registry
February 18, 2016
CompletedStudy Start
First participant enrolled
April 5, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 14, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 14, 2017
CompletedResults Posted
Study results publicly available
March 19, 2020
CompletedMarch 19, 2020
March 1, 2020
1.4 years
February 8, 2016
July 30, 2019
March 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Secondary Outcomes (3)
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)
Number of Participants With Intra-operative and Post-operative Adverse Events (AEs)
Baseline up to 13 days
Study Arms (1)
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
Interventions
TachoSil is a collagen matrix that is coated with human fibrinogen and human thrombin.
Eligibility Criteria
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.
You may qualify if:
- Inpatients planned for laparoscopic surgery, in the field of gynecology, urology and abdominal surgery where pre-rolled TachoSil was applied, 18 years or older.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (8)
Landeskrankenhaus Hochsteiermark, Standort Bruck a.d. Mur; Abteilung fur Chirurgie
Bruck an der Mur, Austria
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
MeSH Terms
Interventions
Results Point of Contact
- Title
- Medical Director
- Organization
- Takeda
Study Officials
- STUDY DIRECTOR
Medical Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 8, 2016
First Posted
February 18, 2016
Study Start
April 5, 2016
Primary Completion
August 14, 2017
Study Completion
August 14, 2017
Last Updated
March 19, 2020
Results First Posted
March 19, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will share
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.