Nasal DeformitySEG-PROMNCT07531810
Patient-Reported Outcomes and Complications After Structural Rhinoplasty Using Septal Extension Grafts
An observational study of Nasal Deformity and Rhinoplasty, run by Cumhuriyet University Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasal Deformity, Rhinoplasty, Nasal Obstruction
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2026to Jun 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing primary structural rhinoplasty with septal extension graft at a tertiary referral center. Patients are consecutively enrolled and followed prospectively.
Who may be able to join
- 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
Who cannot join
- History of previous nasal surgery (revision rhinoplasty)
- Undergoing concomitant major craniofacial procedures
- Missing preoperative PROM data
- Unable to complete postoperative follow-up assessments
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sivas Cumhuriyet University
Sivas, Sivas, 58070
Murat Çelik, Assistant Professor, 05546902104
Handan Derebaşınlıoğlu, Associate Professor, +905322408767, handanderebasinlioglu@gmail.com
About this study
Official title: 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.
Read more
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.
Read the 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
- Keywords
- Structural rhinoplasty, Septal extension graft, Patient reported outcomes, SCHNOS, Rhinoplasty outcomes
- Medical subject headings
- Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to postoperative month 6
Secondary outcomes (3)
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
Measured: 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.
Measured: 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.
Measured: Up to postoperative month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start1 Apr 2026
- Primary completionMar 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Nasal DeformityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murat Çelik, Cumhuriyet University Hospital
- Investigators
- Murat Çelik, Assistant Professor, Principal investigator, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07531810
- Sponsor's protocol ID
- 24.03.2026-28701
- Acronym
- SEG-PROM
- Status last verified
- Jun 2026
- First submitted
- 1 Apr 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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.
PubMed 14990910Moubayed 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.
PubMed 28880988Barone 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.
PubMed 27798735Di 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.
PubMed 39421678Kucukguven 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.
PubMed 37815287Bellamy 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.
PubMed 36728586