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Objective:This study compared the incidence of salivary fistula between groups with an early or late reintroduction of oral feeding, and identified the predictive factors for salivary fistula.Methods:A randomised trial was performed using 89 patients with larynx or hypopharynx cancer, assigned to 2 groups (early or late). In the early group, oral feeding was started 24 hours after total laryngectomy or total pharyngolaryngectomy, and in the late group, it was started from post-operative day 7 onwards. The occurrence of salivary fistula was evaluated in relation to the following variables: early or late oral feeding, nutritional status, cancer stage, surgery performed, and type of neck dissection.Results:The incidence of salivary fistula was 27.3 per cent (n = 12) in the early group and 13.3 per cent (n = 6) in the late group (p = 0.10). The following variables were not statistically significant: nutritional status (p = 0.45); tumour location (p = 0.37); type of surgery (p = 0.91) and type of neck dissection (p = 0.62). A significant difference (p = 0.02) between the free margins and invasive carcinoma was observed.Conclusion:The early reintroduction of oral feeding in total laryngectomised patients did not increase the incidence of salivary fistula. [ABSTRACT FROM PUBLISHER]