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Annemieke H. Ackerstaff, PhD; Frans J. M. Hilgers, MD, PhD; Cees A. Meeuwis, MD, PhD; Lilly-Ann van der Velden, MD; Frank J. A. van den Hoogen, MD, PhD; Henri A. M. Marres, MD, PhD; Gerard C. M. Vreeburg, MD; Johannes J. Manni, MD, PhD

Arch Otolaryngol Head Neck Surg. 1999;125:167-173.

Objectives  To verify the initial results of a new anterograde replacement method of the second-generation indwelling Provox voice prosthesis, Provox 2 (Atos Medical AB, Hörby, Sweden), and to determine its device life.

Design  Nonrandomized, multi-institutional, controlled clinical trial.

Setting  Four academic hospitals and/or comprehensive cancer centers in the Netherlands.

Patients  Two hundred thirty-nine consecutive patients who had undergone laryngectomy and were visiting the outpatient clinic for replacement of their voice prosthesis.

Intervention  Anterograde replacement of the Provox 2 voice prosthesis.

Main Outcome Measures  Evaluation of ease of use by the medical professional and appreciation by the patients, by means of structured questionnaires; comparison of device life between the original Provox and the new Provox 2 voice prosthesis in a subset of patients.

Results  Voice prostheses replaced were Provox (n=188), Groningen (Medin, Groningen, the Netherlands) (n=47), and Nijdam (Medin) (n=4). Anterograde replacement of Provox 2 was always possible. The new anterograde method was preferred by the medical professionals in 97.1% of cases and by 93.7% of the patients, who reported significantly reduced discomfort (P<.001). There was no significant difference in device life between Provox and Provox 2 (median, 125.5 and 104 days, respectively). In 57.5% of patients, the Provox 2 device life was shorter and in 42.5% it was longer (sign test, P=.09).

Conclusions  The results of the initial study concerning ease of use for the medical professionals and decreased discomfort for the patients of the new anterograde replacement procedure of the Provox 2 prosthesis were confirmed. The device life of Provox and that of Provox 2 were comparable, despite the alterations needed to optimize the Provox 2 prosthesis for the anterograde procedure.

From the Departments of Otorhinolaryngology–Head and Neck Surgery of the Netherlands Cancer Institute, Amsterdam (Drs Ackerstaff and Hilgers), University Hospital Dijkzigt and Dr Daniel den Hoed Cancer Centre, Rotterdam (Drs Meeuwis and van der Velden), University Hospital St Radboud, Nijmegen (Drs van den Hoogen and Marres), and University Hospital Maastricht, Maastricht (Drs Vreeburg and Manni), the Netherlands.

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