Development and (pre-) clinical assessment of a novel surgical tool for primary and secondary tracheoesophageal puncture with immediate voice prosthesis insertion, the Provox Vega Puncture Set
Hilgers, Frans J.M. (University of Amsterdam)
Lorenz, Kai J. (German Armed Forces Hospital (Ulm, Alemanya))
Maier, Heinz (German Armed Forces Hospital (Ulm, Alemanya))
Meeuwis, Cees A. (Eramsus University Medical Center)
Kerrebijn, Jeroen D.F. (Eramsus University Medical Center (Rotterdam, Països Baixos))
Vander Poorten, Vincent (University Hospital Leuven (Leuven, Bèlgica))
Vinck, Anne Sophie (University Hospital Leuven (Leuven, Bèlgica))
Quer, Miquel (Institut d'Investigació Biomèdica Sant Pau)
Van Den Brekel, Michiel W.M. (University of Amsterdam)
Universitat Autònoma de Barcelona. Departament de Cirurgia

Data:	2013
Resum:	Development and (pre-) clinical assessment were performed of a novel surgical tool for primary and secondary tracheoesophageal puncture (TEP) with immediate voice prosthesis (VP) insertion in laryngectomized patients, the Provox Vega Puncture Set (PVPS). After preclinical assessment in fresh frozen cadavers, a multicenter prospective clinical feasibility study in two stages was performed. Stage-1 included 20 patients, and stage-2 had 27. Based on observations in stage-1, the PVPS was re-designed (decrease in diameter of the dilator from 23. 5 to 18 Fr. ) and further used in stage-2. Primary outcome measure was immediate VP insertion without requiring additional instruments. Secondary outcome measures for comparison of the new with the traditional TEP procedure were: appreciation, ease of use, time consumption, estimated surgical risks and overall preference. A mini-max two-stage study design was used to establish the required sample size. In stage-1, dilatation forces were considered too high in patients with a fibrotic TE wall. With the final thinner version of the PVPS, VPs were successfully inserted into the TEP in 'one-go' in 24/27 (89%) of TEPs: 20 primary and 7 secondary. Participating surgeons rated appreciation, ease of use, time consumption and estimated surgical risks as better. Related adverse events were few and minor. The new PVPS appeared to be the preferred device by all participating surgeons. This study shows that the novel, disposable PVPS is a useful TEP instrument allowing quick and easy insertion of the VP in the vast majority of cases without requiring additional instruments.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Primary and secondary TEP ; Seldinger technique ; Total laryngectomy ; Tracheoesophageal puncture (TEP) ; Voice prosthesis
Publicat a:	European archives of oto-rhino-laryngology, Vol. 270, Núm. 1 (january 2013) , p. 255-262, ISSN 1434-4726

DOI: 10.1007/s00405-012-1976-9
PMID: 22392519

8 p, 387.0 KB

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Documents de recerca > Documents dels grups de recerca de la UAB > Centres i grups de recerca (producció científica) > Ciències de la salut i biociències > Institut de Recerca Sant Pau
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