RollOut -Pre-Rolled TachoSil in Laparoscopic Utilisation. A Non-Interventional Study

Laparoscopy Clinical Trial

Official title:

RollOut -Pre-Rolled TachoSil in Laparoscopic Utilisation. A Non-Interventional Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02685007
• Other study ID #: TachoSil-4001
• Secondary ID: NIS005460
• Status: Completed
• Start date: April 5, 2016
• Est. completion date: August 14, 2017

Study information

• Verified date: March 2020
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: August 14, 2017
• Est. primary completion date: August 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Laparoscopy

Intervention

Other:
• Tachosil
TachoSil is a collagen matrix that is coated with human fibrinogen and human thrombin.

Locations

Country	Name	City	State
Austria	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	Klinikum Wels-Grieskirchen GmbH; Abteilung fur Urologie	Wels
Austria	Univ.-Klinik fur Chirurgie; Klin. Abt. fur Allgemeinchirurgie	Wien

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Post-surgery until hospital discharge (up to 13 days)
Secondary	Duration of Hospital Stay		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.	Intra-surgery and post-surgery until hospital discharge (up to 13 days)
Secondary	Number of Participants With Intra-operative and Post-operative Adverse Events (AEs)		Baseline up to 13 days