The objective of the study was to investigate the influence of anti-reflux medications on the management of periprosthetic leakage in laryngectomised patients with prosthetic voice rehabilitation. Sixty patients underwent laryngectomy and prosthetic voice rehabilitation. In a prospective non-randomised study, we examined the patients clinically and assessed the presence of reflux disease using 24-h dual-probe pH monitoring before and 6 months after oral anti-reflux treatment with proton pump inhibitors (PPIs). The severity of reflux, the effectiveness of anti-reflux therapy, and the clinical success of treatment were evaluated. Reflux parameters before and after anti-reflux therapy as well as the severity and incidence of periprosthetic leakage before and after PPI therapy were the main outcome measures. The absolute number of reflux events was 162.2 (±144.3) before treatment and 63.1 (±87.9) after treatment with PPIs (p = 0.031). The reflex area index score decreased from 327.1 (±419.3) without PPIs to 123.8 (±249.7) with PPIs (p = 0.0228). The mean DeMeester score was 108.3 (±85.4) before treatment and 47.4 (±61.7) after 6 months of treatment (p = 0.0557). The relative risk of periprosthetic leakage decreased to 0.5 after anti-reflux treatment. In 19 patients, leakage problems were successfully managed by rigorous treatment with PPIs. No further surgical procedures were required in these cases. Rigorous anti-reflux treatment leads to an improvement in parameters that can be assessed objectively by 24-h dual-probe pH monitoring. In the majority of patients, the symptoms associated with periprosthetic leakage can be improved or cured.

Objectives The purpose of this 2-year prospective nonrandomized study was to investigate the relationship between pathological supraesophageal reflux and the occurrence of speech fistula complications, especially severe fistula enlargement, in patients who underwent total laryngectomy and prosthetic voice restoration. Methods We objectively assessed the presence of reflux disease using 24-hour dual-probe pH monitoring in 60 laryngectomized patients, correlated the incidence of tracheoesophageal fistula complications with the severity of reflux, and assessed the risk of problems by determining the absolute number of reflux events at the level of the speech fistula, the reflux area index score, and the DeMeester score. Results All patients with fistula enlargement showed highly pathological results in the diagnostic tests for reflux disease. Depending on reflux severity, the relative risk of developing fistula complications was up to 10 times higher for these patients. Conclusions We found a significant correlation between the occurrence of tracheoesophageal fistula complications and the severity of supraesophageal reflux. Potential chronic irritation of the esophageal and tracheal mucosa can possibly contribute to the development of these problems. If the presence of reflux disease has been confirmed by 24-hour dual-probe pH monitoring, patients with fistula complications should be treated with proton pump inhibitors.

Supra-esophageal reflux influences voice quality and quality of life in laryngectomised patients with voice prostheses. This can be explained, for example, by an increased incidence of periprosthetic leakage, the presence of edema in the pharyngo-esophageal segment (where speech is produced), and general reflux symptoms. Rigorous treatment with anti-reflux medications leads to an improvement in reflux parameters that can be assessed objectively (RAI) and in correlated quality of life and voice quality parameters. For this reason, we recommend rigorous oral treatment with PPIs in laryngectomised patients with a confirmed diagnosis of supra-esophageal reflux.

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.

Patients with recurrent periprosthetic leakage in the region of the fistula showed a significantly higher number of supra-oesophageal reflux episodes. Rigorous anti-reflux treatment can help manage or prevent leakage problems in a large proportion of patients.