Patient-Reported Outcomes and Complications After Structural Rhinoplasty Using Septal Extension Grafts
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCumhuriyet University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
History of previous nasal surgery (revision rhinoplasty)
Undergoing concomitant major craniofacial procedures
Missing preoperative PROM data
Unable to complete postoperative follow-up assessments
Trial population
Adult patients undergoing primary structural rhinoplasty with septal extension graft at a tertiary referral center. Patients are consecutively enrolled and followed prospectively.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
50 Participants
are grouped into 1 trial groupGroup A: Structural Rhinoplasty with Septal Extension Graft
Trial outcomes
Primary outcomes
1
Change from Baseline in Total Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS) Score at 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.
Time frame
Baseline to postoperative month 6Secondary outcomes
1
Change from Baseline in Rhinoplasty Outcome Evaluation (ROE) Score at Postoperative Month 6
Change in the score of the Rhinoplasty Outcome Evaluation (ROE) from preoperative baseline to postoperative month 6. The ROE score ranges from 0 to 100, with higher scores indicating better patient satisfaction and improved outcomes
Time frame
Baseline to postoperative month 62
Change from Baseline in Nasal Obstruction Symptom Evaluation (NOSE) Score at Postoperative Month 6
Change in the score of the Nasal Obstruction Symptom Evaluation (NOSE) scale from preoperative baseline to postoperative month 6. The NOSE score ranges from 0 to 100, with higher scores indicating more severe nasal obstruction symptoms.
Time frame
Baseline to postoperative month 63
Revision Surgery Rate Within 6 Months
Proportion of patients requiring revision surgery within 6 months following the primary rhinoplasty procedure.
Time frame
Up to postoperative month 6Other outcomes
1
Change from Baseline in Total Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS) Score at Postoperative Month 1
Change in the total score of the Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS) from preoperative baseline to postoperative month 1. The SCHNOS total score ranges from 0 to 100, with higher scores indicating worse nasal symptoms and poorer aesthetic outcomes.
Time frame
Baseline to postoperative month 12
Change from Baseline in Total Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS) Score at Postoperative Month 3
Change in the total score of the Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS) from preoperative baseline to postoperative month 3. The SCHNOS total score ranges from 0 to 100, with higher scores indicating worse nasal symptoms and poorer aesthetic outcomes.
Time frame
Baseline to postoperative month 33
Change from Baseline in Rhinoplasty Outcome Evaluation (ROE) Score at Postoperative Month 1
Change in the score of the Rhinoplasty Outcome Evaluation (ROE) from preoperative baseline to postoperative month 1. The ROE score ranges from 0 to 100, with higher scores indicating better patient satisfaction and improved outcomes.
Time frame
Baseline to postoperative month 14
Change from Baseline in Rhinoplasty Outcome Evaluation (ROE) Score at Postoperative Month 3
Change in the score of the Rhinoplasty Outcome Evaluation (ROE) from preoperative baseline to postoperative month 3. The ROE score ranges from 0 to 100, with higher scores indicating better patient satisfaction and improved outcomes.
Time frame
Baseline to postoperative month 3Sponsors and contacts
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Source ClinicalTrials.gov