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
Abstract 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 fres...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
Hilgers, Frans J. M. [verfasserIn] Lorenz, Kai J. [verfasserIn] Maier, Heinz [verfasserIn] Meeuwis, Cees A. [verfasserIn] Kerrebijn, Jeroen D. F. [verfasserIn] Vander Poorten, Vincent [verfasserIn] Vinck, Anne Sophie [verfasserIn] Quer, Miquel [verfasserIn] van den Brekel, Michiel W. M. [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2012 |
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| Schlagwörter: |
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| Übergeordnetes Werk: |
Enthalten in: European archives of oto-rhino-laryngology and head & neck - Berlin : Springer, 1864, 270(2012), 1 vom: 06. März, Seite 255-262 |
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| Übergeordnetes Werk: |
volume:270 ; year:2012 ; number:1 ; day:06 ; month:03 ; pages:255-262 |
| Links: |
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| DOI / URN: |
10.1007/s00405-012-1976-9 |
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| Katalog-ID: |
SPR005183995 |
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| 245 | 1 | 0 | |a 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 |
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| 520 | |a Abstract 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. | ||
| 650 | 4 | |a Total laryngectomy |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Tracheoesophageal puncture (TEP) |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Voice prosthesis |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Primary and secondary TEP |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Seldinger technique |7 (dpeaa)DE-He213 | |
| 700 | 1 | |a Lorenz, Kai J. |e verfasserin |4 aut | |
| 700 | 1 | |a Maier, Heinz |e verfasserin |4 aut | |
| 700 | 1 | |a Meeuwis, Cees A. |e verfasserin |4 aut | |
| 700 | 1 | |a Kerrebijn, Jeroen D. F. |e verfasserin |4 aut | |
| 700 | 1 | |a Vander Poorten, Vincent |e verfasserin |4 aut | |
| 700 | 1 | |a Vinck, Anne Sophie |e verfasserin |4 aut | |
| 700 | 1 | |a Quer, Miquel |e verfasserin |4 aut | |
| 700 | 1 | |a van den Brekel, Michiel W. M. |e verfasserin |4 aut | |
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10.1007/s00405-012-1976-9 doi (DE-627)SPR005183995 (SPR)s00405-012-1976-9-e DE-627 ger DE-627 rakwb eng 610 ASE 44.94 bkl Hilgers, Frans J. M. verfasserin aut 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 2012 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract 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. Total laryngectomy (dpeaa)DE-He213 Tracheoesophageal puncture (TEP) (dpeaa)DE-He213 Voice prosthesis (dpeaa)DE-He213 Primary and secondary TEP (dpeaa)DE-He213 Seldinger technique (dpeaa)DE-He213 Lorenz, Kai J. verfasserin aut Maier, Heinz verfasserin aut Meeuwis, Cees A. verfasserin aut Kerrebijn, Jeroen D. F. verfasserin aut Vander Poorten, Vincent verfasserin aut Vinck, Anne Sophie verfasserin aut Quer, Miquel verfasserin aut van den Brekel, Michiel W. M. verfasserin aut Enthalten in European archives of oto-rhino-laryngology and head & neck Berlin : Springer, 1864 270(2012), 1 vom: 06. März, Seite 255-262 (DE-627)253722667 (DE-600)1459042-6 1434-4726 nnns volume:270 year:2012 number:1 day:06 month:03 pages:255-262 https://dx.doi.org/10.1007/s00405-012-1976-9 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_267 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_711 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2070 GBV_ILN_2086 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2116 GBV_ILN_2118 GBV_ILN_2119 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.94 ASE AR 270 2012 1 06 03 255-262 |
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10.1007/s00405-012-1976-9 doi (DE-627)SPR005183995 (SPR)s00405-012-1976-9-e DE-627 ger DE-627 rakwb eng 610 ASE 44.94 bkl Hilgers, Frans J. M. verfasserin aut 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 2012 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract 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. Total laryngectomy (dpeaa)DE-He213 Tracheoesophageal puncture (TEP) (dpeaa)DE-He213 Voice prosthesis (dpeaa)DE-He213 Primary and secondary TEP (dpeaa)DE-He213 Seldinger technique (dpeaa)DE-He213 Lorenz, Kai J. verfasserin aut Maier, Heinz verfasserin aut Meeuwis, Cees A. verfasserin aut Kerrebijn, Jeroen D. F. verfasserin aut Vander Poorten, Vincent verfasserin aut Vinck, Anne Sophie verfasserin aut Quer, Miquel verfasserin aut van den Brekel, Michiel W. M. verfasserin aut Enthalten in European archives of oto-rhino-laryngology and head & neck Berlin : Springer, 1864 270(2012), 1 vom: 06. März, Seite 255-262 (DE-627)253722667 (DE-600)1459042-6 1434-4726 nnns volume:270 year:2012 number:1 day:06 month:03 pages:255-262 https://dx.doi.org/10.1007/s00405-012-1976-9 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_267 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_711 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2070 GBV_ILN_2086 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2116 GBV_ILN_2118 GBV_ILN_2119 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.94 ASE AR 270 2012 1 06 03 255-262 |
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10.1007/s00405-012-1976-9 doi (DE-627)SPR005183995 (SPR)s00405-012-1976-9-e DE-627 ger DE-627 rakwb eng 610 ASE 44.94 bkl Hilgers, Frans J. M. verfasserin aut 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 2012 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract 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. Total laryngectomy (dpeaa)DE-He213 Tracheoesophageal puncture (TEP) (dpeaa)DE-He213 Voice prosthesis (dpeaa)DE-He213 Primary and secondary TEP (dpeaa)DE-He213 Seldinger technique (dpeaa)DE-He213 Lorenz, Kai J. verfasserin aut Maier, Heinz verfasserin aut Meeuwis, Cees A. verfasserin aut Kerrebijn, Jeroen D. F. verfasserin aut Vander Poorten, Vincent verfasserin aut Vinck, Anne Sophie verfasserin aut Quer, Miquel verfasserin aut van den Brekel, Michiel W. M. verfasserin aut Enthalten in European archives of oto-rhino-laryngology and head & neck Berlin : Springer, 1864 270(2012), 1 vom: 06. März, Seite 255-262 (DE-627)253722667 (DE-600)1459042-6 1434-4726 nnns volume:270 year:2012 number:1 day:06 month:03 pages:255-262 https://dx.doi.org/10.1007/s00405-012-1976-9 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_267 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_711 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2070 GBV_ILN_2086 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2116 GBV_ILN_2118 GBV_ILN_2119 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.94 ASE AR 270 2012 1 06 03 255-262 |
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10.1007/s00405-012-1976-9 doi (DE-627)SPR005183995 (SPR)s00405-012-1976-9-e DE-627 ger DE-627 rakwb eng 610 ASE 44.94 bkl Hilgers, Frans J. M. verfasserin aut 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 2012 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract 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. Total laryngectomy (dpeaa)DE-He213 Tracheoesophageal puncture (TEP) (dpeaa)DE-He213 Voice prosthesis (dpeaa)DE-He213 Primary and secondary TEP (dpeaa)DE-He213 Seldinger technique (dpeaa)DE-He213 Lorenz, Kai J. verfasserin aut Maier, Heinz verfasserin aut Meeuwis, Cees A. verfasserin aut Kerrebijn, Jeroen D. F. verfasserin aut Vander Poorten, Vincent verfasserin aut Vinck, Anne Sophie verfasserin aut Quer, Miquel verfasserin aut van den Brekel, Michiel W. M. verfasserin aut Enthalten in European archives of oto-rhino-laryngology and head & neck Berlin : Springer, 1864 270(2012), 1 vom: 06. März, Seite 255-262 (DE-627)253722667 (DE-600)1459042-6 1434-4726 nnns volume:270 year:2012 number:1 day:06 month:03 pages:255-262 https://dx.doi.org/10.1007/s00405-012-1976-9 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_267 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_711 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2070 GBV_ILN_2086 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2116 GBV_ILN_2118 GBV_ILN_2119 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.94 ASE AR 270 2012 1 06 03 255-262 |
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10.1007/s00405-012-1976-9 doi (DE-627)SPR005183995 (SPR)s00405-012-1976-9-e DE-627 ger DE-627 rakwb eng 610 ASE 44.94 bkl Hilgers, Frans J. M. verfasserin aut 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 2012 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract 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. Total laryngectomy (dpeaa)DE-He213 Tracheoesophageal puncture (TEP) (dpeaa)DE-He213 Voice prosthesis (dpeaa)DE-He213 Primary and secondary TEP (dpeaa)DE-He213 Seldinger technique (dpeaa)DE-He213 Lorenz, Kai J. verfasserin aut Maier, Heinz verfasserin aut Meeuwis, Cees A. verfasserin aut Kerrebijn, Jeroen D. F. verfasserin aut Vander Poorten, Vincent verfasserin aut Vinck, Anne Sophie verfasserin aut Quer, Miquel verfasserin aut van den Brekel, Michiel W. M. verfasserin aut Enthalten in European archives of oto-rhino-laryngology and head & neck Berlin : Springer, 1864 270(2012), 1 vom: 06. März, Seite 255-262 (DE-627)253722667 (DE-600)1459042-6 1434-4726 nnns volume:270 year:2012 number:1 day:06 month:03 pages:255-262 https://dx.doi.org/10.1007/s00405-012-1976-9 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_267 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_711 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2070 GBV_ILN_2086 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2116 GBV_ILN_2118 GBV_ILN_2119 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.94 ASE AR 270 2012 1 06 03 255-262 |
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English |
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Enthalten in European archives of oto-rhino-laryngology and head & neck 270(2012), 1 vom: 06. März, Seite 255-262 volume:270 year:2012 number:1 day:06 month:03 pages:255-262 |
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Enthalten in European archives of oto-rhino-laryngology and head & neck 270(2012), 1 vom: 06. März, Seite 255-262 volume:270 year:2012 number:1 day:06 month:03 pages:255-262 |
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Total laryngectomy Tracheoesophageal puncture (TEP) Voice prosthesis Primary and secondary TEP Seldinger technique |
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European archives of oto-rhino-laryngology and head & neck |
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Hilgers, Frans J. M. @@aut@@ Lorenz, Kai J. @@aut@@ Maier, Heinz @@aut@@ Meeuwis, Cees A. @@aut@@ Kerrebijn, Jeroen D. F. @@aut@@ Vander Poorten, Vincent @@aut@@ Vinck, Anne Sophie @@aut@@ Quer, Miquel @@aut@@ van den Brekel, Michiel W. M. @@aut@@ |
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2012-03-06T00:00:00Z |
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M.</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">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</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2012</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">Text</subfield><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">Abstract 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. 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| author |
Hilgers, Frans J. M. |
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Hilgers, Frans J. M. ddc 610 bkl 44.94 misc Total laryngectomy misc Tracheoesophageal puncture (TEP) misc Voice prosthesis misc Primary and secondary TEP misc Seldinger technique 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 |
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Hilgers, Frans J. M. |
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610 ASE 44.94 bkl 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 Total laryngectomy (dpeaa)DE-He213 Tracheoesophageal puncture (TEP) (dpeaa)DE-He213 Voice prosthesis (dpeaa)DE-He213 Primary and secondary TEP (dpeaa)DE-He213 Seldinger technique (dpeaa)DE-He213 |
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ddc 610 bkl 44.94 misc Total laryngectomy misc Tracheoesophageal puncture (TEP) misc Voice prosthesis misc Primary and secondary TEP misc Seldinger technique |
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ddc 610 bkl 44.94 misc Total laryngectomy misc Tracheoesophageal puncture (TEP) misc Voice prosthesis misc Primary and secondary TEP misc Seldinger technique |
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ddc 610 bkl 44.94 misc Total laryngectomy misc Tracheoesophageal puncture (TEP) misc Voice prosthesis misc Primary and secondary TEP misc Seldinger technique |
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Elektronische Aufsätze Aufsätze Elektronische Ressource |
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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 |
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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 |
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Hilgers, Frans J. M. |
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European archives of oto-rhino-laryngology and head & neck |
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Hilgers, Frans J. M. Lorenz, Kai J. Maier, Heinz Meeuwis, Cees A. Kerrebijn, Jeroen D. F. Vander Poorten, Vincent Vinck, Anne Sophie Quer, Miquel van den Brekel, Michiel W. M. |
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Hilgers, Frans J. M. |
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10.1007/s00405-012-1976-9 |
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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 |
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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 |
| abstract |
Abstract 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. |
| abstractGer |
Abstract 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. |
| abstract_unstemmed |
Abstract 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. |
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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 |
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| score |
7.399976 |