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

Takeda131 enrolled

Overview

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).

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

131

Conditions

Laparoscopy

Interventions

TachosilOTHER

TachoSil is a collagen matrix that is coated with human fibrinogen and human thrombin.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (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

Outcomes

Primary Outcomes

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.

Time frame: Post-surgery until hospital discharge (up to 13 days)

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

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.

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

Data from ClinicalTrials.gov

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