The Role of Spreader Grafts in Reduction Rhinoseptoplasty: a Randomized Clinical Trial With Quality of Life Assessment
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Nasal Obstruction Symptom Evaluation Scale (NOSE)
研究概览
简要总结
Nasal obstruction is one of the majors concerns in reduction rhinoseptoplasty, because it affects quality of life and surgical outcomes. Is the association of middle third grafts with reduction rhinoseptoplasty responsible for an increase in quality of life related to nasal obstruction when compared to reduction rhinoseptoplasty without the placement of these grafts?
详细描述
Reduction rhinoplasty and rhinoseptoplasty are among the most accomplished aesthetic procedures in Plastic Surgery and Otorhinolaryngology. Nasal obstruction is one of the majors concerns in this procedures, because it affects quality of life and surgical outcomes. Nasal surgeons have paid much attention to nasal valve area to prevent nasal obstruction and some assert reconstruction of the middle vault after dorsal reduction with grafts. The gold standard for middle vault reconstruction after dorsal reduction has been the spreader graft, first advocated by Sheen. Studies in surgical techniques for the treatment of nasal valve collapse focus much more in techniques than in evidence of its efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients eligible for reduction rhinoseptoplasty who agreed to participate in the study and who did not meet the exclusion criteria
排除标准
- •Absence of nasal obstruction;
- •Previous nasosinusal surgery;
- •Symmetrical or asymmetric insufficiency of the middle third that would justify the placement of middle third grafts for the treatment of these problems;
- •Presence of nasal valve insufficiency as the only cause of nasal obstruction;
- •Cranio-facial anomalies;
- •Presence of nasosinusal tumors;
- •Active acute rhinosinusitis;
- •Patients undergoing treatment of other entities concomitant to rhinoseptoplasty such as: sinus inflammatory surgery, adenoid hypertrophy removal, septal perforation correction, otoplasty or blepharoplasty.
结局指标
主要结局
Nasal Obstruction Symptom Evaluation Scale (NOSE)
时间窗: 180 postoperative days
The NOSE will be used to measure the quality of life related to nasal obstruction. It is a validated instrument specifically designed for use in patients with nasal obstruction. According to this scale patients are asked to evaluate difficulty breathing in a general way and specifically the difficulty in breathing through the nose, breathing during sleep, and severity of their nasal congestion. The severity of the symptoms is recorded on a scale of 0 to 4, with 0 being the absence of a problem and 4 being a serious problem. The possible scores range from 0 to 20 and the higher scores indicate a higher degree of nasal obstruction. The sum of the scores is multiplied by 5 so as to obtain a final score ranging from 0 to 100, with higher values associated with poorer quality of life. The scale will be applied at the base line and at 30, 90 and 180 postoperative days.
次要结局
- Visual Analogue Scale - Nasal Obstruction(180 postoperative days)
- Clinical Diagnosis of Allergic Rhinitis(Base line and 180 postoperative days)
- Complications(7 until 180 postoperative days)
- Rhinoplasty Outcome Evaluation (ROE) Scale(180 postoperative days)
- Anterior Rhinoscopy and Nasal Endoscopy(Base line and 180 postoperative days)