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
Open Access
- 6 March 2012
- journal article
- research article
- Published by Springer Science and Business Media LLC in European Archives of Oto-Rhino-Laryngology
- Vol. 270 (1), 255-262
- https://doi.org/10.1007/s00405-012-1976-9
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.Keywords
This publication has 15 references indexed in Scilit:
- Simplified technique of tracheoesophageal prosthesis placement at the time of secondary tracheoesophageal puncture (TEP)The Laryngoscope, 2011
- Clinical phase I/feasibility study of the next generation indwelling Provox voice prosthesis (Provox Vega)Acta Oto-Laryngologica, 2009
- Evaluation of voice prosthesis placement at the time of primary tracheoesophageal puncture with total laryngectomyThe Laryngoscope, 2009
- Endoscopic Percutaneous Dilatational Tracheotomy: A Prospective Evaluation of 500 Consecutive CasesThe Laryngoscope, 2005
- Anatomical and Functional Correlates of Voice Quality in Tracheoesophageal SpeechJournal of Voice, 2005
- Primary Speech Restoration at Laryngectomy by Insertion of Voice Prosthesis - 10 Years' ExperienceActa Oto-Laryngologica, 2000
- The Nijdam Voice Prosthesis: A Self-retaining Valveless Voice Prosthesis for Vocal Rehabilitation after Total LaryngectomyActa Oto-Laryngologica, 1996
- A new low‐resistance, self‐retaining prosthesis (Provox™) for voice rehabilitation after total laryngectomyThe Laryngoscope, 1990
- Optimal two-stage designs for phase II clinical trialsControlled Clinical Trials, 1989
- A new prosthesis for voice rehabilitation after laryngectomyArchives of Oto-Rhino-Laryngology, 1982