title: Effect of perioperative proton pump inhibitors on the incidence of pharyngocutaneous fistula after total laryngectomy: a prospective randomized controlled trial.
abstract: BACKGROUND
  Pharyngocutaneous fistula is a common complication of total laryngectomy. We hypothesized that perioperative proton pump inhibitor (PPI) treatment could reduce the incidence of pharyngocutaneous fistulae.
  
  
  METHODS
  This prospective placebo-controlled double-blind randomized controlled trial compared PPI treatment (14 days enteral omeprazole) with a placebo in patients undergoing primary total laryngectomy.
  
  
  RESULTS
  Forty patients were randomized into PPI (n = 21) and placebo arms (n = 19). One of 21 patients receiving omeprazole developed a fistula in comparison to 6 of 19 patients in the placebo group (p = .04). No other statistically significant risk factors for pharyngocutaneous fistula were identified. The mean hospital stay of patients with and without a fistula was 32 and 7.5 days, respectively.
  
  
  CONCLUSIONS
  Pharyngocutaneous fistulae result in prolonged hospitalization and morbidity. We observed a statistically significant reduction in fistulae with PPI prophylaxis. Further research to better define the role of reflux and antacid management is suggested.
authors.affiliation: Division of Otorhinolaryngology, University of Cape Town, Groote Schuur Hospital, Cape Town, South Africa.
authors.forename: Kate A
authors.initials: KA
authors.lastname: Stephenson
authors.forename: Johannes J
authors.initials: JJ
authors.lastname: Fagan
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017577:Cutaneous Fistula / Q000517:prevention & control*; D004311:Double-Blind Method; D005260:Female; D005402:Fistula / Q000517:prevention & control*; D006801:Humans; D007822:Laryngeal Neoplasms / Q000601:surgery; D007825:Laryngectomy / Q000009:adverse effects*; D007902:Length of Stay / Q000706:statistics & numerical data; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000627:therapeutic use; D019990:Perioperative Care; D010608:Pharyngeal Diseases / Q000517:prevention & control*; D011446:Prospective Studies; D054328:Proton Pump Inhibitors / Q000627:therapeutic use*
chemical_list: D054328:Proton Pump Inhibitors; D009853:Omeprazole
keywords: laryngectomy; omeprazole; pharyngocutaneous fistula; proton pump inhibitor; reflux