ABSTRACT
BACKGROUND: The use of voice prostheses has been considered the gold standard in voice rehabilitation following laryngectomy for the last 20 years. Insertion is generally performed as a primary procedure during laryngectomy or as a secondary procedure with a re-usable trocar or rigid esophagoscope, a guidewire and anatomic hemostatic forceps. The use of these instruments requires a certain level of experience on the one hand, while on the other use of a trocar and subsequent manipulation with the hemostatic forceps can lead to tissue trauma around the membranous wall or damage to the voice prosthesis. We present the results of a phase I/II study using a novel atraumatic puncture set for primary and secondary insertion of voice prostheses. PATIENTS AND METHODS: Once patients had been fully informed and given their consent, the Provox-Vega® puncture set was used in 21 patients in either a primary (16) or a secondary (5) procedure. All procedures were documented on video, while approach, complications and surgical success were recorded using a questionnaire. RESULTS: The average surgical time was 83.5 (± 19.12) s for primary voice prosthesis insertion and 212.57 (± 93.03) s in secondary procedures. The prosthesis could be inserted without complication in 19 patients, while a longer prosthesis needed to be selected intraoperatively in two patients due to a thick membranous wall. No serious complications were observed. One patient incurred a discrete injury to the mucosa of the esophageal posterior wall. CONCLUSION: The Provox-Vega® puncture set proved itself to be a safe aid in the insertion of voice prostheses. It is significantly easier to use than other systems and tissue trauma is minimal. In most cases, no further instruments were required.
