Oncological outcome of contralateral submental artery island flap versus primary closure in tongue squamous cell carcinoma: randomized non-inferiority clinical trial

The aim of this study was to test the non-inferiority of the contralateral submental island flap (CSIF) compared with primary closure (PC) regarding local recurrence after partial glossectomy in patients with oral tongue squamous cell carcinoma (OTSCC). This open-label, non-inferiority randomized controlled trial enrolled patients with cT1 –2 lateralized OTSCC. The primary outcome was local recurrence by 12 months postoperative. Non-inferiority would be declared if the upper limit of the two-sided 95% confidence interval (CI) for the proportion difference in local recurrence between the two groups did not exceed a non-inferiority ma rgin of 15.0%.
Source: International Journal of Oral and Maxillofacial Surgery - Category: ENT & OMF Authors: Tags: Randomised Clinical Trial Source Type: research