NCT02685007

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 131 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Laparoscopy

Interventions

Type	Name	Description
OTHER	Tachosil	TachoSil is a collagen matrix that is coated with human fibrinogen and human thrombin.

Timeline

• Start date: 2016-04-05
• Primary completion: 2017-08-14
• Completion: 2017-08-14
• First posted: 2016-02-18
• Last updated: 2020-03-19
• Results posted: 2020-03-19

Locations

8 sites across 1 country: Austria