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

Официальное название

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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Change from Baseline in Total Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS) Score at Postoperative Month 6 [Срок оценки: Baseline to postoperative month 6]

Вторичные конечные точки (3)

• Change from Baseline in Rhinoplasty Outcome Evaluation (ROE) Score at Postoperative Month 6 [Срок оценки: Baseline to postoperative month 6]
• Change from Baseline in Nasal Obstruction Symptom Evaluation (NOSE) Score at Postoperative Month 6 [Срок оценки: Baseline to postoperative month 6]
• Revision Surgery Rate Within 6 Months [Срок оценки: Up to postoperative month 6]

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Turkey (Türkiye) · 1 центр

• Sivas Cumhuriyet University — Sivas

Публикации

• 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. PMID 14990910
• 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. PMID 28880988
• 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. PMID 27798735
• 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. PMID 39421678
• 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. PMID 37815287
• 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. PMID 36728586

Идентификаторы

NCT: NCT07531810 · 24.03.2026-28701

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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