Journal of stomatology, oral and maxillofacial surgery · 2024
Complications of preseptal versus retroseptal transconjunctival approach for isolated orbital floor fracture repair: A double-blind, non-inferiority, randomized, split-face controlled trial.
Сравнительное исследованиеEquivalence TrialСтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Pitak-Arnnop Poramate, Tangmanee Chatpong, Urwannachotima Nipaporn, Subbalekha Keskanya, Sirintawat Nattapong, Meningaud Jean-Paul, Hersant Barbara, Stoll Christian
Аннотация
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.
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.