Ex-vivo-Vergleichsstudie zur Morcellationseffizienz unterschiedlicher Morcellatoren

Zusammenfassung

Einleitung

Die anatomische Enukleation der Prostata (AEEP) ist eine Behandlungsoption für die Behandlung der benignen Prostatahyperplasie, unabhängig von der Größe der Prostata. Während Fortschritte in der Lasertechnologie zu klinischen Verbesserungen in der Enukleationsphase geführt haben, wurde der Morcellationsprozess wenig weiterentwickelt, sodass es wenige Innovationen bei Morcellationsgeräten gab. Ziel dieser Studie war es, die Effizienz zwischen 2 Morcellatoren in einem Ex-vivo-Modell zu vergleichen: dem Piranha (Richard Wolf GmbH, Knittlingen) und einem neu eingeführten, noch nicht kommerziell erhältlichen Morcellator, dem ActiveCut (Active Fiber Systems GmbH, Jena).

Material und Methoden

Die 2 Morcellatoren wurden in einem neu entwickelten Ex-vivo-Modell getestet. In beiden Gruppen wurden wiederverwendbare Messerklingen je 10-mal bei vergleichbaren Geschwindigkeitseinstellungen getestet. Bei jeder Morcellation wurden 60 g rohes Rinderherz morcelliert. Anschließend wurde die Effizienz der Morcellation verglichen. Endpunkte waren die Morcellationseffizienz (g/min) und die Evaluation eines möglichen Verschleißes der Messer über die Versuche hinweg. Die Mittelwerte kontinuierlicher Variablen wurden unter Verwendung des t-Tests mit Standardabweichung verglichen.

Ergebnisse

Insgesamt wurden 10 aufeinanderfolgende Morcellationen mit jedem Morcellatorsystem durchgeführt. Der ActiveCut zeigte höhere Morcellationsraten mit 12,43 g/min im Vergleich zum Piranha mit 7,09 g/min (p<0,05). Allerdings zeigte der ActiveCut-Morcellator über 10 Versuche hinweg abnehmende Morcellationsraten. In 2 Fällen musste Gewebe während der Morcellation aus der Klingenkupplung entfernt werden, während der Piranha-Morcellator konstante Morcellationsraten ohne Fehlfunktion aufwies.

Schlussfolgerung

In dieser Ex-vivo-Studie, die den ActiveCut- und den Piranha-Morcellator vergleicht, zeigte der ActiveCut eine höhere Morcellationseffizienz. Allerdings wurde der ActiveCut bisher noch nicht klinisch getestet; in zukünftigen klinischen Studien müssen daher sowohl die Sicherheit als auch mögliche Fehlfunktionen sorgfältig geprüft werden.

Abstract

Introduction

Anatomical enucleation of the prostate (AEEP) is an established treatment option for benign prostatic hyperplasia (BPH), regardless of prostate size. While advancements in laser technology have significantly improved the enucleation phase, the morcellation process has remained relatively unchanged, with limited innovations in morcellation devices. This study aimed to compare the efficiency of two morcellators in an ex-vivo model: the Piranha morcellator (Richard Wolf GmbH, Knittlingen) and a newly introduced, yet-to-be-commercialized device, the ActiveCut morcellator (Active Fiber Systems GmbH, Jena).

Materials and Methods

The two morcellators were tested in a newly developed ex-vivo model. In both groups, reusable blades were tested ten times at comparable speed settings. For each trial, 60 grams of raw bovine heart tissue were morcellated. The efficiency of the morcellation was then analyzed. Primary endpoints included morcellation efficiency (g/min) and an evaluation of blade deterioration over repeated use. The mean values of continuous variables were compared using a t-test with standard deviation.

Results

A total of ten consecutive morcellation trials were conducted with each device. The ActiveCut demonstrated higher morcellation rates at 12.43 g/min, compared to 7.09 g/min with the Piranha morcellator (p<0.05). However, the ActiveCut showed a decline in efficiency over ten trials. In two cases, tissue had to be manually removed from the blade coupling during morcellation, whereas the Piranha morcellator maintained consistent performance without malfunctions.

Conclusion

In this ex-vivo study, comparing the ActiveCut and Piranha morcellators, the ActiveCut exhibited higher morcellation efficiency. However, as the ActiveCut has not yet undergone clinical testing, future clinical studies are necessary to assess its safety and potential malfunctions before clinical implementation.

Schlüsselwörter

Morcellation - ActiveCut - Piranha - Prostata-Enukleation - benigne Prostatahyperplasie

Keywords

morcellation - ActiveCut - piranha - prostate enucleation - benign prostatic hyperplasia

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