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

NCT07531810 | Recruiting

• 1 other identifier: 24.03.2026-28701
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nasal Deformity; Rhinoplasty; Nasal Obstruction

Keywords

Structural rhinoplasty; Septal extension graft; Patient reported outcomes; SCHNOS; Rhinoplasty outcomes

Outcome Measures

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.

  Baseline to postoperative month 6

Secondary Outcomes (3)

• Change from Baseline in Rhinoplasty Outcome Evaluation (ROE) Score at Postoperative Month 6

  Baseline to postoperative month 6

• Change from Baseline in Nasal Obstruction Symptom Evaluation (NOSE) Score at Postoperative Month 6

  Baseline to postoperative month 6

• Revision Surgery Rate Within 6 Months

  Up to postoperative month 6

Other Outcomes (4)

• Change from Baseline in Total Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS) Score at Postoperative Month 1

  Baseline to postoperative month 1

• Change from Baseline in Total Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS) Score at Postoperative Month 3

  Baseline to postoperative month 3

• Change from Baseline in Rhinoplasty Outcome Evaluation (ROE) Score at Postoperative Month 1

  Baseline to postoperative month 1

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cumhuriyet University Hospital: lead

Study Sites (1)

Sivas Cumhuriyet University

Sivas, Sivas, 58070, Turkey (Türkiye)

RECRUITING

Related Publications (6)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Nasal Obstruction

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases

Study Officials

• Murat Çelik, Assistant Professor

  Cumhuriyet University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Murat Çelik, Assistant Professor

CONTACT

+905546902104; mucetr@gmail.com

Handan Derebaşınlıoğlu, Associate Professor

CONTACT

+905322408767; handanderebasinlioglu@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Plastic, Reconstructive and Aesthetic Surgery

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 15, 2026
• Study Start: March 24, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)