NCT07531810

Patient-Reported Outcomes and Complications After Structural Rhinoplasty Using Septal Extension Grafts

Patient-Reported Outcomes and Complications Following Structural Rhinoplasty Using Septal Extension Grafts: A Prospective Cohort Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Cumhuriyet University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. Follow-up evaluations are planned at approximately 1, 3, and 6 months. Early postoperative assessments may be influenced by edema; therefore, later time points will be considered more representative of stable outcomes. Data will be collected prospectively using standardized case report forms with predefined variables. PROM data will be obtained through patient-completed questionnaires at each visit. Clinical findings, including postoperative status and complications, will be recorded during routine follow-up examinations. Data entry will be performed contemporaneously at each visit. Postoperative complications will be recorded and categorized according to timing. Revision procedures occurring during the follow-up period will also be documented. The study is structured to allow evaluation of longitudinal changes in PROM scores and to explore potential associations between patient-reported outcomes and clinical findings. Consecutive patient inclusion will be used to reduce selection bias. Data quality will be supported by predefined variable definitions, consistency checks, and periodic data review. Missing data will be documented and handled using appropriate statistical methods for repeated measures analyses. This study aims to characterize longitudinal changes in PROM scores and their relationship with postoperative clinical findings in patients undergoing SEG-based structural rhinoplasty.

Conditions

• Nasal Deformity
• Rhinoplasty
• Nasal Obstruction

Timeline

• Start date: 2026-03-24
• Primary completion: 2027-03-01
• Completion: 2027-06-01
• First posted: 2026-04-15
• Last updated: 2026-04-15

Locations

1 site across 1 country: Turkey (Türkiye)