TY - JOUR
T1 - Complications of preseptal versus retroseptal transconjunctival approach for isolated orbital floor fracture repair
T2 - A double-blind, non-inferiority, randomized, split-face controlled trial
AU - Pitak-Arnnop, Poramate
AU - Tangmanee, Chatpong
AU - Urwannachotima, Nipaporn
AU - Subbalekha, Keskanya
AU - Sirintawat, Nattapong
AU - Meningaud, Jean Paul
AU - Hersant, Barbara
AU - Stoll, Christian
N1 - Publisher Copyright:
© 2024 Elsevier Masson SAS
PY - 2024/10
Y1 - 2024/10
N2 - 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.
AB - 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.
KW - Orbital fracture
KW - Postoperative complications
KW - Randomized trial
KW - Transconjunctival approach
KW - Treatment outcomes
UR - http://www.scopus.com/inward/record.url?scp=85198206598&partnerID=8YFLogxK
U2 - 10.1016/j.jormas.2024.101958
DO - 10.1016/j.jormas.2024.101958
M3 - Article
AN - SCOPUS:85198206598
SN - 2468-7855
VL - 125
JO - Journal of Stomatology, Oral and Maxillofacial Surgery
JF - Journal of Stomatology, Oral and Maxillofacial Surgery
IS - 5
M1 - 101958
ER -