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

Takeda

Status: Completed

Conditions: Laparoscopy

Treatments: Other: Tachosil

Study type: Observational

Funder types: Industry

Identifiers

NCT02685007

NIS005460 (Registry Identifier)

TachoSil-4001

Details and patient eligibility

About

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).

Full 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.

Enrollment: 131 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

131 participants in 1 patient group

Inpatients

Description:

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

Treatment:

Other: Tachosil