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

Study Overview

• Status: Completed
• Conditions: Laparoscopy
• Intervention / Treatment: Other: Tachosil

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 Type: Observational
• Enrollment (Actual): 131

Contacts and Locations

Study Locations

• Austria
  • Bruck an der Mur, Austria
    • Landeskrankenhaus Hochsteiermark, Standort Bruck a.d. Mur; Abteilung fur Chirurgie
  • Graz, Austria
    • LKH Universitatsklinikum Graz Universitatklinik fur Chirurgie; Abteilung fur Allgemeinchirurgie
  • Hall in Tirol, Austria
    • Landeskrankenhaus Hall; Allgemeine Chirurgie
  • Linz, Austria
    • Kepler Universitatsklinikum GmbH Med Campus III.; Abteilung Chirurgie II
  • Linz, Austria
    • Krankenhaus der Barmherzigen Schwestern Linz Betriebsges.m.b.H
  • Salzburg, Austria
    • Landeskrankenhaus Salzburg/SALK Universitatsklinikum der PMU; Univ.-Klinik fur Urologie und Andrologie
  • Wels, Austria
    • Klinikum Wels-Grieskirchen GmbH; Abteilung fur Urologie
  • Wien, Austria
    • Univ.-Klinik fur Chirurgie; Klin. Abt. fur Allgemeinchirurgie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Other: Tachosil; TachoSil is a collagen matrix that is coated with human fibrinogen and human thrombin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Takeda

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2016
• Primary Completion (Actual): August 14, 2017
• Study Completion (Actual): August 14, 2017

Study Registration Dates

• First Submitted: February 8, 2016
• First Submitted That Met QC Criteria: February 17, 2016
• First Posted (Estimate): February 18, 2016

Study Record Updates

• Last Update Posted (Actual): March 19, 2020
• Last Update Submitted That Met QC Criteria: March 17, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: minimal invasive surgery
• Other Study ID Numbers: TachoSil-4001; NIS005460 (Registry Identifier: AGES)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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.