Abstract

In a prospective study on patients who developed recurrent periprosthetic leakage in the region of the fistula after laryngectomy and prosthetic voice restoration, we investigated whether there was an increased incidence of supra-oesophageal reflux. A total of 48 patients included 16 patients with recurrent periprosthetic leakage (group A) and 32 patients without periprosthetic leakage (group B). The presence of reflux was objectively assessed using 24-hour dual-probe pH monitoring. The number of supra-oesophageal reflux events, the reflux area index (RAI 4) and the DeMeester score were determined as well as the relative risk of fistula enlargement in relation to the presence of reflux and postoperative radiotherapy. In group A pathological reflux events were detected in 100% of the cases. The mean number of supra-oesophageal reflux episodes was 414.8, the RAI was 419.5 (+/-212.45) and the DeMeester score was 104.4 (+/-21.3). In group B pathological reflux events were found in only 50% of the cases. The mean number of supra-oesophageal reflux episodes was 11.8, the RAI was 146.9 (+/-40.4) and the DeMeester score was 42.9 (+/-11.8). All reflux parameter results for group A patients were significantly higher than those obtained for group B patients. The relative risk of fistula enlargement was 1.8-2.3 times higher in the presence of reflux. Postoperative radiotherapy did not increase the risk of fistula enlargement (relative risk 0.75-0.93). A significantly higher number of supra-oesophageal reflux episodes occurred in patients with recurrent periprosthetic leakage in the region of the fistula. As reflux events may cause problems in the region of the fistula, prophylactic treatment with proton pump inhibitors is recommended.

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