Complications of preseptal versus retroseptal transconjunctival approach for isolated orbital floor fracture repair: A double-blind, non-inferiority, randomized, split-face controlled trial
Issued Date
2024-01-01
Resource Type
eISSN
24687855
Scopus ID
2-s2.0-85198206598
Journal Title
Journal of Stomatology, Oral and Maxillofacial Surgery
Rights Holder(s)
SCOPUS
Bibliographic Citation
Journal of Stomatology, Oral and Maxillofacial Surgery (2024)
Suggested Citation
Pitak-Arnnop P., Tangmanee C., Urwannachotima N., Subbalekha K., Sirintawat N., Meningaud J.P., Hersant B., Stoll C. Complications of preseptal versus retroseptal transconjunctival approach for isolated orbital floor fracture repair: A double-blind, non-inferiority, randomized, split-face controlled trial. Journal of Stomatology, Oral and Maxillofacial Surgery (2024). doi:10.1016/j.jormas.2024.101958 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/99700
Title
Complications of preseptal versus retroseptal transconjunctival approach for isolated orbital floor fracture repair: A double-blind, non-inferiority, randomized, split-face controlled trial
Corresponding Author(s)
Other Contributor(s)
Abstract
Introduction: Effective surgical access to the orbital floor facilitates surgery and mitigates postoperative complications (PC). The aim of this study was to compare PC between the preseptal and retroseptal transconjunctival approaches (PS-TCA/RS-TCA) for isolated orbital floor fracture (OFF). Materials and Methods: Using a double-blind, non-inferiority, randomized, split-face study design, patients aged ≥ 18 years with bilateral isolated OFF were enrolled. A sample size of 177 eyes per group was determined through power analysis. The primary predictor variable was the surgical approach, and the main outcome was the PC rate at month 6. Statistical analyses were computed with a significance level at 0.05 and the non-inferiority margin at a relative risk (RR) of 0.045. Results: The final sample included 193 patients (23.3 % female; age, 42.8 ± 18.1 years). Both TCA variants exhibited comparable PC rates (5.2 % for PS-TCA vs. 7.3 % for RS-TCA; P = 0.53; absolute risk, +2.07 % [95 % CI, -2.74 % to 6.89 %]; RR, 1.4 [95 % CI, 0.64 to 3.07]). Approximately one in every 49 patients experiencing PC with RS-TCA (number needed to harm, 48.3). Conclusions: Both TCA methods can be used without different PC rates at 6 months postoperatively. Future research should focus on TCA in combination with other surgical approaches for multiple orbital wall reconstruction.