Patient-Reported Outcomes and Complications Following Structural Rhinoplasty Using Septal Extension Grafts: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change from Baseline in Total Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS) Score at Postoperative Month 6
研究概览
简要总结
Structural rhinoplasty with septal extension graft (SEG) is commonly used to achieve stable nasal tip support and predictable long-term outcomes. However, surgical success is not limited to structural stability alone and should also be evaluated from the patient's perspective.
Patient-reported outcome measures (PROMs) have gained increasing importance in rhinoplasty, as they reflect patient satisfaction and perceived nasal function. Despite the widespread use of SEG, prospective studies evaluating PROMs together with postoperative clinical findings over time remain limited.
This prospective observational cohort study aims to evaluate longitudinal changes in patient-reported outcomes and postoperative findings in adult patients undergoing primary structural rhinoplasty with SEG-based nasal tip support. Validated PROM instruments will be applied preoperatively and during routine postoperative follow-up visits at approximately 1, 3, and 6 months.
In addition, postoperative complications and revision procedures will be recorded. The study aims to provide a more comprehensive understanding of patient-centered outcomes and their relationship with clinical findings in SEG-based rhinoplasty.
详细描述
Structural rhinoplasty is performed to achieve stable and lasting aesthetic and functional outcomes by rebuilding and maintaining the nasal framework. Among nasal tip support techniques, the septal extension graft (SEG) is widely used due to its ability to provide reliable control of nasal tip projection and rotation while maintaining structural stability.
Surgical success in rhinoplasty is not limited to anatomical outcomes alone. Patient perception of nasal function and appearance plays a key role in overall satisfaction. Therefore, patient-reported outcome measures (PROMs) have become an important component in outcome assessment.
Despite the widespread use of SEG, prospective data evaluating longitudinal changes in PROMs together with postoperative clinical findings remain limited. Clinical factors such as tip stiffness, palpable grafts, columellar deviation, and the need for revision surgery may influence patient-reported outcomes, but their relationship with PROM score changes over time has not been clearly defined.
This study is designed as a single-center, prospective observational cohort including consecutive adult patients undergoing primary structural rhinoplasty with SEG-based tip support. All procedures will be performed by the same surgical team using a standardized structural approach, with additional techniques applied as required based on individual anatomical characteristics.
Patient-reported outcomes will be assessed using validated instruments, including the Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS), the Rhinoplasty Outcome Evaluation (ROE), and the Nasal Obstruction Symptom Evaluation (NOSE) scale. Assessments will be performed preoperatively and at postoperative follow-up visits.
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
- •Age 18 years or older
- •Undergoing primary structural rhinoplasty with septal extension graft
- •Able to understand and complete patient-reported outcome questionnaires (PROMs)
- •Willing to participate and provide written informed consent
排除标准
- •History of previous nasal surgery (revision rhinoplasty)
- •Undergoing concomitant major craniofacial procedures
- •Missing preoperative PROM data
- •Unable to complete postoperative follow-up assessments
研究组 & 干预措施
Structural Rhinoplasty with Septal Extension Graft
Adult patients undergoing primary structural rhinoplasty with septal extension graft (SEG)-based nasal tip support. All patients are treated using a standardized surgical approach by the same surgical team, with additional techniques applied as needed according to individual anatomy. Patients are followed prospectively and evaluated using patient-reported outcome measures and clinical outcomes.
结局指标
主要结局
Change from Baseline in Total Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS) Score at Postoperative Month 6
时间窗: Baseline to postoperative month 6
Change in the total score of the Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS) from preoperative baseline to postoperative month 6. The SCHNOS score ranges from 0 to 100, with higher scores indicating worse nasal symptoms and poorer aesthetic outcomes. Postoperative month 6 represents a time point at which most postoperative edema has subsided and nasal structures are relatively stable.
次要结局
- Change from Baseline in Rhinoplasty Outcome Evaluation (ROE) Score at Postoperative Month 6(Baseline to postoperative month 6)
- Change from Baseline in Nasal Obstruction Symptom Evaluation (NOSE) Score at Postoperative Month 6(Baseline to postoperative month 6)
- Revision Surgery Rate Within 6 Months(Up to postoperative month 6)
研究者
Murat Çelik
Assistant Professor of Plastic, Reconstructive and Aesthetic Surgery
Cumhuriyet University Hospital