Clinical trial NCT02685007: RollOut -Pre-Rolled TachoSil in Laparoscopic Utilisation. A Non-Interventional Study
Official title: RollOut -Pre-Rolled TachoSil in Laparoscopic Utilisation. A Non-Interventional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Laparoscopy
Keywords: minimal invasive surgery
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2016-02-18
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population will include inpatients planned for laparoscopic surgery, in the field of gynecology, urology and visceral surgery and where pre-rolled TachoSil will be applied.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Investigators Assessment of Tachosil
timeFrame: Post-surgery until hospital discharge (up to 13 days)
Secondary outcomes:
measure: Duration of Hospital Stay
timeFrame: From date of surgery until hospital discharge (up to 13 days)
measure: Number of Participants With Pharmaco-economic Evaluation Based on Surgeon's Assessment
timeFrame: Intra-surgery and post-surgery until hospital discharge (up to 13 days)
measure: Number of Participants With Intra-operative and Post-operative Adverse Events (AEs)
timeFrame: Baseline up to 13 days
Other outcomes:
Locations:
city: Bruck an der Mur
country: Austria
facility: Landeskrankenhaus Hochsteiermark, Standort Bruck a.d. Mur; Abteilung fur Chirurgie
city: Graz
country: Austria
facility: LKH Universitatsklinikum Graz Universitatklinik fur Chirurgie; Abteilung fur Allgemeinchirurgie
city: Hall in Tirol
country: Austria
facility: Landeskrankenhaus Hall; Allgemeine Chirurgie
city: Linz
country: Austria
facility: Kepler Universitatsklinikum GmbH Med Campus III.; Abteilung Chirurgie II
city: Linz
country: Austria
facility: Krankenhaus der Barmherzigen Schwestern Linz Betriebsges.m.b.H
city: Salzburg
country: Austria
facility: Landeskrankenhaus Salzburg/SALK Universitatsklinikum der PMU; Univ.-Klinik fur Urologie und Andrologie
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen GmbH; Abteilung fur Urologie
city: Wien
country: Austria
facility: Univ.-Klinik fur Chirurgie; Klin. Abt. fur Allgemeinchirurgie
Study officials:
affiliation: Takeda
name: Medical Director
role: STUDY_DIRECTOR
References: