title: [A novel puncture instrument: the Provox-Vega® puncture set. Its use in voice prosthesis insertion following laryngectomy].
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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors: Klinik für Hals-Nasen-Ohren-Heilkunde, Kopf-Hals-Chirurgie, Bundeswehrkrankenhaus Ulm, Oberer Eselsberg 40, 89081, Ulm, Deutschland. kai.lorenz@extern.uni-ulm.de
authors: K J
authors: KJ
authors: Lorenz
authors: F M
authors: FM
authors: Hilgers
authors: H
authors: H
authors: Maier
mesh_terms: D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D005858:Germany; D006801:Humans; D007825:Laryngectomy / Q000295:instrumentation / Q000534:rehabilitation*; D007831:Larynx, Artificial; D008297:Male; D017060:Patient Satisfaction; D011183:Postoperative Complications / Q000209:etiology; D011446:Prospective Studies; D011474:Prosthesis Design; D011677:Punctures / Q000295:instrumentation*; D013525:Surgical Instruments; D011795:Surveys and Questionnaires; D013996:Time and Motion Studies