Patient-Reported Outcomes and Complications After Structural Rhinoplasty Using Septal Extension Grafts (SEG-PROM)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Nasal Obstruction; Rhinoplasty; Nasal Deformity

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.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Murat Çelik, Assistant Professor; Phone Number: +905546902104; Email: mucetr@gmail.com
• Study Contact Backup: Name: Handan Derebaşınlıoğlu, Associate Professor; Phone Number: +905322408767; Email: handanderebasinlioglu@gmail.com

Study Locations

• Turkey (Türkiye)
  • Sivas
    • Sivas, Sivas, Turkey (Türkiye), 58070
      • Recruiting
      • Sivas Cumhuriyet University
      • Contact: Handan Derebaşınlıoğlu, Associate Professor; Phone Number: +905322408767; Email: handanderebasinlioglu@gmail.com
      • Contact: Murat Çelik, Assistant Professor; Phone Number: 05546902104
      • Principal Investigator: Handan Derebaşınlıoğlu, Associate Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing primary structural rhinoplasty with septal extension graft at a tertiary referral center. Patients are consecutively enrolled and followed prospectively.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• History of previous nasal surgery (revision rhinoplasty)
• Undergoing concomitant major craniofacial procedures
• Missing preoperative PROM data
• Unable to complete postoperative follow-up assessments

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to postoperative month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline to postoperative month 6
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.	Baseline to postoperative month 6
Revision Surgery Rate Within 6 Months	Proportion of patients requiring revision surgery within 6 months following the primary rhinoplasty procedure.	Up to postoperative month 6

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to postoperative month 1
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.	Baseline to postoperative month 3
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.	Baseline to postoperative month 1
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.	Baseline to postoperative month 3

Collaborators and Investigators

• Sponsor: Cumhuriyet University Hospital
• Investigators: Principal Investigator: Murat Çelik, Assistant Professor, Cumhuriyet University

Publications and helpful links

General Publications

• Stewart MG, Witsell DL, Smith TL, Weaver EM, Yueh B, Hannley MT. Development and validation of the Nasal Obstruction Symptom Evaluation (NOSE) scale. Otolaryngol Head Neck Surg. 2004 Feb;130(2):157-63. doi: 10.1016/j.otohns.2003.09.016.
• Moubayed SP, Ioannidis JPA, Saltychev M, Most SP. The 10-Item Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS) for Functional and Cosmetic Rhinoplasty. JAMA Facial Plast Surg. 2018 Jan 1;20(1):37-42. doi: 10.1001/jamafacial.2017.1083.
• Barone M, Cogliandro A, Di Stefano N, Tambone V, Persichetti P. A systematic review of patient-reported outcome measures after rhinoplasty. Eur Arch Otorhinolaryngol. 2017 Apr;274(4):1807-1811. doi: 10.1007/s00405-016-4359-9. Epub 2016 Oct 31.
• Di Giuli R, Mafi P, Belloni LM, Vaccari S, Klinger F, Roxo CW. Achieving a Strong and Straight Septal Extension Graft: A Novel Four-step Surgical Approach in Rhinoplasty. Plast Reconstr Surg Glob Open. 2024 Oct 16;12(10):e6272. doi: 10.1097/GOX.0000000000006272. eCollection 2024 Oct.
• Kucukguven A, Celik M, Altunal SK, Kocer U. Nasal Tip Flexibility and Stability: Comparison of Septal Extension Grafts and Columellar Strut Grafts in a Prospective Trial. Plast Reconstr Surg. 2024 Aug 1;154(2):313-322. doi: 10.1097/PRS.0000000000011132. Epub 2023 Oct 10.
• Bellamy JL, Rohrich RJ. Superiority of the Septal Extension Graft over the Columellar Strut Graft in Primary Rhinoplasty: Improved Long-Term Tip Stability. Plast Reconstr Surg. 2023 Aug 1;152(2):332-339. doi: 10.1097/PRS.0000000000010147. Epub 2023 Jul 27.

Study record dates

Study Major Dates

• Study Start (Estimated): March 24, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: April 1, 2026
• First Submitted That Met QC Criteria: April 13, 2026
• First Posted (Actual): April 15, 2026

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Patient reported outcomes; Septal extension graft; Structural rhinoplasty; SCHNOS; Rhinoplasty outcomes
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Nose Diseases; Otorhinolaryngologic Diseases; Respiratory Insufficiency; Airway Obstruction; Nasal Obstruction
• Other Study ID Numbers: 24.03.2026-28701

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No