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 margin of 15.0%. The functional outcome was assessed for superiority through secondary outcomes. In the intention-to-treat analysis, the local recurrence rate was 3.1% (1/32) in the CSIF group versus 9.4% (3/32) in the PC group; the proportion difference was - 6.3% (95% CI -18.0% to 5.5%). In the per-protocol analysis, the local recurrence rate was 3.1% (1/32) versus 3.3% (1/30); the proportion difference was - 0.2% (95% CI -9% to 8.6%). Speech was significantly superior in the CSIF group (P = 0.001). In conclusion, the CSIF was found to be non-inferior to PC regarding local recurrence at 1 year. A limitation of this study is the relatively large non-inferiority margin and consequently relatively small sample size. Further studies with a smaller non-inferiority margin and therefore larger sample size are needed to validate these findings.

Computer-guided contouring of craniofacial fibrous dysplasia involving the zygoma using a patient-specific surgical depth guide.

The aim of this study was to introduce a new computer-guided technique for contouring and shaving of craniofacial fibrous dysplasia involving the zygoma. Computer-guided contouring was performed for five patients with unilateral craniofacial fibrous dysplasia involving the zygoma, using a patient-specific surgical depth guide. This patient-specific guide with depth holes was virtually designed for each patient based on mirroring of the unaffected side. The guide was printed using rapid prototyping. In the surgical theatre, the guide was seated in place and implant drills were inserted through the guide holes, creating depth holes according to the preoperative planning. Bone removal was then continued using surgical burs and/or bone chisels, connecting the guiding depth holes. Satisfaction with facial aesthetics was evaluated by the patients using a Likert scale, and by the surgeons using the Whitaker rating scale. All patients were satisfied with the postoperative facial aesthetics. Four patients were rated category I on the Whitaker rating scale, and one patient as category II. In conclusion, this patient-specific surgical depth guide appears to offer a solution for the unpredictability of conventional bone removal in unilateral craniofacial fibrous dysplasia, especially in three-dimensional multiplanar areas such as the zygoma. Further investigations are required.