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Completed

NCT Number: NCT02685007

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).

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Key information

Conditions

Laparoscopy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Tachosil

Other

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

Primary outcomes

  1. Investigators Assessment of Tachosil

    Time frame: 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 outcomes

  1. Duration of Hospital Stay

    Time frame: From date of surgery until hospital discharge (up to 13 days)

  2. Number of Participants With Pharmaco-economic Evaluation Based on Surgeon's Assessment

    Time frame: 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.

  3. Number of Participants With Intra-operative and Post-operative Adverse Events (AEs)

    Time frame: Baseline up to 13 days

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 18, 2016
Registry last updated
Mar 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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