Correction: Frequency of hemorrhage after tooth extraction in patients treated with a direct oral anticoagulant: A multicenter cross-sectional study.

[This corrects the article DOI: 10.1371/journal.pone.0266011.].

Protocol for a multicentre, prospective observational study of elective neck dissection for clinically node-negative oral tongue squamous cell carcinoma (END-TC study).

INTRODUCTION: In early-stage oral tongue squamous cell carcinoma (OTSCC), elective neck dissection (END) is recommended when occult lymph node metastasis is suspected; however, there is no unanimous consensus on the risks and benefits of END in such cases. The management of clinically node-negative (cN0) OTSCC remains controversial. This study, therefore, aimed to evaluate the efficacy of END and its impact on the quality of life (QoL) of patients with cN0 OTSCC. METHODS AND ANALYSIS: This is a prospective, multicentre, nonrandomised observational study. The choice of whether to perform END at the same time as resection of the primary tumour is based on institutional policy and patient preference. The primary endpoint of this study is 3-year overall survival. The secondary endpoints are 3-year disease-specific survival, 3-year relapse-free survival and the impact on patient QoL. Propensity score-matching analysis will be performed to reduce selection bias. ETHICS AND DISSEMINATION: This study was approved by the Clinical Research Review Board of the Nagasaki University. The protocol of this study was registered at the University Hospital Medical Information Network Clinical Trials Registry. The datasets generated during the current study will be available from the corresponding author on reasonable request. The results will be disseminated internationally, through scientific and professional conferences and in peer-reviewed medical journals. TRIAL REGISTRATION NUMBER: UMIN000027875.

Frequency of hemorrhage after tooth extraction in patients treated with a direct oral anticoagulant: A multicenter cross-sectional study.

OBJECTIVE: Few studies have compared the frequency of hemorrhages after tooth extraction between patients taking direct oral anticoagulants (DOACs) and those taking warfarin or no anticoagulants. Further, the effects of the timing of DOAC administration and tooth extraction on the frequency of post-extraction hemorrhage have not been demonstrated. Therefore, we compared the frequency of post-extraction hemorrhages in patients in these different conditions and examined the effects of the timing of DOAC administration and tooth extraction on the frequency. DESIGN: Prospective multicenter study. SETTING: Eighty-six Japanese hospitals. PARTICIPANTS: In total, 182 teeth extracted from 145 individuals (119 teeth from adult males) receiving dabigatran and 88 teeth from individuals (62 teeth from adult males) receiving rivaroxaban were included. INTERVENTION: Tooth extraction was followed by a 7-day observational period between November 1, 2008 and December 31, 2015. Dabigatran was administered twice daily; rivaroxaban was administered once a day. PRIMARY OUTCOME MEASURE: Hemorrhage after tooth extraction. RESULTS: The frequency of hemorrhage after tooth extraction was 1.65%, 3.41%, and 3.63% in those treated with dabigatran, rivaroxaban, and warfarin, respectively, and 0.39% in those who did not receive anticoagulants. Hemorrhages after tooth extraction were significantly higher in the rivaroxaban group than in patients who did not receive anticoagulants (P = 0.008). These frequencies did not differ significantly in the dabigatran and rivaroxaban groups compared to the warfarin group (P = 0.221 and P = 1.000, respectively). CONCLUSIONS: The frequency of hemorrhaging after tooth extraction appeared to be similar in patients receiving continuous dabigatran or rivaroxaban and in those receiving continuous warfarin.