The Laryngoscope · 2025
The Role of Spreader Grafts in Reduction Septorhinoplasty: A Randomized Clinical Trial With Quality of Life Assessment.
СтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Migliavacca Raphaella, Lavinsky Michelle, Friedrich Eduardo Priesnitz, de Freitas Toledo Samuel Afonso, de Azeredo Andreza Mariane, Silva Denise Rossato
Аннотация
OBJECTIVE: To evaluate the impact of spreader grafts in reduction septorhinoplasty on quality of life (QOL) outcomes.
TRIAL DESIGN: Randomized clinical trial (RCT).
METHODS: Individuals over 15 years old with nasal obstruction were evaluated for functional and aesthetic septorhinoplasty from October 2018 to October 2022 at a facial plastic surgery clinic of a tertiary university hospital in Brazil. Participants were randomly allocated to subjects with or without spreader grafts.
PRIMARY OUTCOME: Relative changes in specific Nasal Obstruction Symptom Evaluation in the Portuguese language (NOSE-p). Outcomes were assessed at least 6 and 12 months postoperatively (PO ≥ 6 and PO ≥ 12 m). The participants and those assessing the outcomes were blinded to group assignment.
RESULTS: A 50 patients were included, 25 randomized to each group, mainly Caucasians with moderate/severe allergic rhinitis symptoms. Mean age was 32.89 ± 13.36 years and 68% were female. Septorhinoplasty improved specific quality-of-life scores irrespective of using spreader grafts (p < 0.001). There was no difference between subjects submitted or not to placement of spreader grafts in NOSE-p score in PO ≥ 6 m (-60.0 vs. -66.6%; p = 0.37); ROE in PO ≥ 6 m (71.83 vs. 79.56; p = 0.35), NO-VAS in PO ≥ 6 m (13.00 vs. 8.00; p = 0,35), NOSE p in PO ≥ 12 m (-53.14% vs. -68.33%; p = 0.28), ROE in PO ≥ 12 m (76.33 vs. 79.53; p = 0.645), NO-VAS in PO ≥ 12 m (13.00 vs. 11.50; p = 0.60).
CONCLUSIONS: Reduction septorhinoplasty was associated with improvement in quality of life regarding nasal obstruction irrespective of using spreader grafts in a 7.88-month follow-up.
TRIAL REGISTRATION: ClinicalTrials.gov identifier: (NCT0449946).
TRIAL DESIGN: Randomized clinical trial (RCT).
METHODS: Individuals over 15 years old with nasal obstruction were evaluated for functional and aesthetic septorhinoplasty from October 2018 to October 2022 at a facial plastic surgery clinic of a tertiary university hospital in Brazil. Participants were randomly allocated to subjects with or without spreader grafts.
PRIMARY OUTCOME: Relative changes in specific Nasal Obstruction Symptom Evaluation in the Portuguese language (NOSE-p). Outcomes were assessed at least 6 and 12 months postoperatively (PO ≥ 6 and PO ≥ 12 m). The participants and those assessing the outcomes were blinded to group assignment.
RESULTS: A 50 patients were included, 25 randomized to each group, mainly Caucasians with moderate/severe allergic rhinitis symptoms. Mean age was 32.89 ± 13.36 years and 68% were female. Septorhinoplasty improved specific quality-of-life scores irrespective of using spreader grafts (p < 0.001). There was no difference between subjects submitted or not to placement of spreader grafts in NOSE-p score in PO ≥ 6 m (-60.0 vs. -66.6%; p = 0.37); ROE in PO ≥ 6 m (71.83 vs. 79.56; p = 0.35), NO-VAS in PO ≥ 6 m (13.00 vs. 8.00; p = 0,35), NOSE p in PO ≥ 12 m (-53.14% vs. -68.33%; p = 0.28), ROE in PO ≥ 12 m (76.33 vs. 79.53; p = 0.645), NO-VAS in PO ≥ 12 m (13.00 vs. 11.50; p = 0.60).
CONCLUSIONS: Reduction septorhinoplasty was associated with improvement in quality of life regarding nasal obstruction irrespective of using spreader grafts in a 7.88-month follow-up.
TRIAL REGISTRATION: ClinicalTrials.gov identifier: (NCT0449946).