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Effect of perioperative proton pump inhibitors on the incidence of pharyngocutaneous fistula after total laryngectomy: A prospective randomized controlled trial
Author(s) -
Stephenson Kate A.,
Fagan Johannes J.
Publication year - 2015
Publication title -
head and neck
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.012
H-Index - 127
eISSN - 1097-0347
pISSN - 1043-3074
DOI - 10.1002/hed.23591
Subject(s) - medicine , laryngectomy , placebo , omeprazole , surgery , randomized controlled trial , proton pump inhibitor , perioperative , incidence (geometry) , fistula , complication , prospective cohort study , anesthesia , larynx , physics , alternative medicine , pathology , optics
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. Conclusion 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. © 2014 Wiley Periodicals, Inc. Head Neck 37 : 255‐259, 2015