title: Customization of the voice prosthesis to prevent leakage from the enlarged tracheoesophageal puncture: results of a prospective trial.
abstract: OBJECTIVE
  Customization of the tracheoesophageal (TE) voice prosthesis (VP) is often preferred over surgical closure to prevent aspiration around the VP in laryngectomized patients with an enlarged tracheoesophageal puncture (TEP), but it has not been thoroughly evaluated.
  
  
  METHODS
  Single-institution prospective trial.
  
  
  METHODS
  A prospective trial was conducted to evaluate the effectiveness of a customized VP with the addition of an enlarged tracheal and/or esophageal collar in patients with leakage around an enlarged TEP. Absence of leakage around the VP after placement defined immediate effectiveness. Long-term success was defined by the prevention of adverse events related to leakage during the study period. Events that defined failure included: permanent gastrostomy dependence, aspiration pneumonia, and/or surgical TEP closure.
  
  
  RESULTS
  Twenty-one patients with enlarged TEP were enrolled (2003-2006). Insertion of a customized VP was unsuccessful in one patient; 145 customizations were performed in the remaining 20 patients (median, 3.5 customizations) during the trial period. Of the customizations, 77% (112/145) prevented leakage immediately after VP insertion. The most common adverse event was dislodgement of the prosthesis (11%) or the collar alone (7%) in 18% (26/145) of customized VP placements. Six patients who died of disease were not evaluable for long-term outcomes. Long-term success was achieved in 80% (12/15) of evaluable patients who avoided permanent gastrostomy, aspiration pneumonia, and surgical TEP closure.
  
  
  CONCLUSIONS
  Prosthetic customization offers an effective method to prevent leakage around the VP in many patients with an enlarged TEP, thereby preserving TE voice while avoiding surgical closure in this high-risk population.
authors: Department of Head and Neck Surgery, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA. jlewin@mdanderson.org
authors: Jan S
authors: JS
authors: Lewin
authors: Katherine A
authors: KA
authors: Hutcheson
authors: Denise A
authors: DA
authors: Barringer
authors: Lindsay E
authors: LE
authors: Croegaert
authors: Asher
authors: A
authors: Lisec
authors: Mark S
authors: MS
authors: Chambers
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D057868:Anastomotic Leak / Q000517:prevention & control*; D005260:Female; D006801:Humans; D007831:Larynx, Artificial; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000517:prevention & control*; D011446:Prospective Studies; D011474:Prosthesis Design; D017755:Prosthesis Fitting; D012086:Reoperation; D013072:Speech, Esophageal