Functional and Aesthetic Outcome Analysis in External Septorhinoplasty
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 750
- 试验地点
- 1
- 主要终点
- Measurement of pre- and postoperative changes in nasal obstruction using peak nasal inspiratory flow:
研究概览
简要总结
A prospective observational cohort study that measures pre- and postoperative outcome of septorhinoplasty by means of patient-related outcome measures (PROMS: NOSE, FACE-Q, Utrecht Questionnaire, SCHNOS and BDDQ-AS) as well as with functional tests (NAR, AR, PNIF).
详细描述
Introduction:
In an ENT setting, septorhinoplasty is frequently performed for both functional and aesthetic reasons. Therefore, pre- and postoperative evaluation of patients' 'total' satisfaction regarding their nasal appearance and functional result is paramount.
Objectives:
To measure the pre- and postoperative functional and aesthetic outcome in patients undergoing an external septorhinoplasty.
Design, setting, participants:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at least 18 years old
- •Patients eligible for external septorhinoplasty: patients seen in consultation because of nasal obstruction were evaluated. Patients who had symptoms of nasal obstruction for at least 1 year that were the result of an identifiable anatomical cause such as septal deviation, turbinate hypertrophy, internal valve collapse, or external valve collapse were included in the study.
排除标准
- •< 18 years
- •mental or physical incapacity to answer the questionnaires
- •nasal fracture or surgery in the past year
- •nasal cocaine use in the past year
结局指标
主要结局
Measurement of pre- and postoperative changes in nasal obstruction using peak nasal inspiratory flow:
时间窗: 12 months
Change between pre- and postoperative peak nasal inspiratory flow: •PNIF (peak nasal inspiratory flow): peak nasal inspiratory flow (l/min) is measured for each nostril separately.
Measurement of pre- and postoperative changes in aesthetic satisfaction Utrecht Questionnaire: 6 items scale: - 5 items with Likert scale from 5 (not at all) to 25 very (often) - 1 item: VAS score from 0 (very ugly) to 10 (very nice)
时间窗: 12 months
Change between pre- and postoperative results of Utrecht questionnaire.
Measurement of pre- and postoperative changes in aesthetic satisfaction and nasal obstruction using the SCHNOS Questionnaire
时间窗: 12 months
Change between pre- and postoperative results of SCHNOS questionnaire. 10 items scale from 0 (no problem) to 5 (severe problem).
Measurement of pre- and postoperative changes in aesthetic satisfaction using the BDD (Body Dysmorphic Disorder) Questionnaire. 7 items scale: item 1-2 : dichotomous (yes/no) Item 3-6: 1(mild) to 5 (extreme) Item 7: dichotomous (yes/no)
时间窗: 12 months
Change between pre- and postoperative results of BDD questionnaire.
Measurement of pre- and postoperative changes in nasal obstruction using NOSE questionnaire
时间窗: 12 months
Change between pre- and postoperative results of NOSE questionnaire. • NOSE (Nasal Obstruction and Septoplasty Effectiveness Scale): scale from 0 (no nasal obstruction) to 100 (severe nasal obstruction).
Measurement of pre- and postoperative changes in nasal obstruction using acoustic rhinometry
时间窗: 12 months
Change between pre- and postoperative acoustic rhinometry: •AR (acoustic rhinometry): minimal cross-sectional area (cm2) (MCA) is measured for each nostril separately.
Measurement of pre- and postoperative changes in aesthetic satisfaction using FACE-Q (TM) questionnaire
时间窗: 12 months
Change between pre- and postoperative results of FACE-Q questionnaire. • FACE-Q (TM): Two items of the FACE-Q (TM) instrument (satisfaction with nose and satisfaction with nostrils) are used: * Subscale 'Satisfaction of the nostrils': score from 0 (very unsatisfied) to 100 (very satisfied). * Subscale 'Satisfaction of the nose': score from 0 (very unsatisfied) to 100 (very satisfied).
Measurement of pre- and postoperative changes in nasal obstruction using rhinomanometry
时间窗: 12 months
Change between pre- and postoperative rhinomanometry : •NAR(nasal anterior rhinomanometry) : nasal airflow at 150 Pa is recorded for each nostril separately (ml/sec).
次要结局
- Correlation between NOSE questionnaire and nasal functional tests(12 months)
- Correlation between change of nasal functional tests and surgical methods(12 months)
研究者
FRANK DECLAU
Head of Otolaryngology Department, Visiting professor
Universiteit Antwerpen