Abstract
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.
Keywords
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Article info
Publication history
Published online: June 04, 2022
Accepted:
May 10,
2022
Identification
Copyright
© 2022 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.
