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

Completed

• Conditions: Laparoscopy
• Interventions: Other: Tachosil

• Registration Number: NCT02685007
• Lead Sponsor: Takeda

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.

Study Timeline

• Study First Submitted: 2016-02-08
• Study First Submitted QC: 2016-02-17
• Study First Posted: 2016-02-18
• Study Start: 2016-04-05
• Primary Completion: 2017-08-14
• Study Completion: 2017-08-14
• Results First Submitted: 2019-07-30
• Status Verified: 2020-03
• Results First Submitted QC: 2020-03-17
• Last Update Submitted: 2020-03-17
• Results First Posted: 2020-03-19
• Last Update Posted: 2020-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Inpatients	Tachosil	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (8)

LKH Universitatsklinikum Graz Universitatklinik fur Chirurgie; Abteilung fur Allgemeinchirurgie; 🇦🇹 Graz, Austria

Landeskrankenhaus Hall; Allgemeine Chirurgie; 🇦🇹 Hall in Tirol, Austria

Landeskrankenhaus Salzburg/SALK Universitatsklinikum der PMU; Univ.-Klinik fur Urologie und Andrologie; 🇦🇹 Salzburg, Austria

Kepler Universitatsklinikum GmbH Med Campus III.; Abteilung Chirurgie II; 🇦🇹 Linz, Austria

Univ.-Klinik fur Chirurgie; Klin. Abt. fur Allgemeinchirurgie; 🇦🇹 Wien, Austria

Landeskrankenhaus Hochsteiermark, Standort Bruck a.d. Mur; Abteilung fur Chirurgie; 🇦🇹 Bruck an der Mur, Austria

Krankenhaus der Barmherzigen Schwestern Linz Betriebsges.m.b.H; 🇦🇹 Linz, Austria

Klinikum Wels-Grieskirchen GmbH; Abteilung fur Urologie; 🇦🇹 Wels, Austria