Evaluation of the Outcome of Septoplasty With or Without Inferior Turbinate Reduction

NCT07731152 — Not applicable, Not yet recruiting, 40 participants, Sohag University

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RegistryNCT07731152
StatusNot yet recruiting
PhaseNot applicable
Study typeInterventional; non randomized, parallel, masking: none, treatment
Enrollment40 (Estimated)
SponsorSohag University (Other)
ConditionsDeviated Nasal Septum, Nasal Obstruction Septal Deviation Compensatory Inferior Turbinate Hypertrophy
Interventionsseptoplasty, septoplasty with inferior turbinate reduction. (Procedure)
Datesstart 2026-09-01 (estimated), primary completion 2027-09-01 (estimated), completion 2027-09-01 (estimated), first posted 2026-07-28, last updated 2026-07-28

Related Papers Related Patents Related Grants Related Experts
All trials for Deviated Nasal Septum All trials for Nasal Obstruction Septal Deviation Compensatory Inferior Turbinate Hypertrophy All trials of septoplasty All trials of septoplasty with inferior turbinate reduction.

-Summary

This prospective comparative study aims to evaluate the outcomes of septoplasty with or without inferior turbinate reduction in patients with symptomatic deviated nasal septum. Subjective and objective outcomes will be assessed using the NOSE score, Peak Nasal Inspiratory Flow (PNIF), and nasal endoscopic examination before and after surgery.

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+Detailed description

This prospective comparative study will be conducted at the Department of Otolaryngology, Sohag University Hospital. The study aims to compare the outcomes of septoplasty alone versus septoplasty combined with inferior turbinate reduction in adult patients with symptomatic deviated nasal septum and persistent nasal obstruction. Forty patients will be enrolled and allocated into two groups. Clinical outcomes will be evaluated preoperatively and at 1 month and 3 months postoperatively using the Nasal Obstruction Symptom Evaluation (NOSE) score, Peak Nasal Inspiratory Flow (PNIF), and diagnostic nasal endoscopy. The primary outcome is improvement in nasal obstruction symptoms, while secondary outcomes include changes in NOSE score, PNIF measurements, and endoscopic findings.

+Arms and interventions

ArmTypeInterventionsDescription
septoplasty aloneActive comparatorProcedure: septoplastyPatients will undergo septoplasty alone for correction of symptomatic deviated nasal septum. Postoperative outcomes will be assessed using NOSE score, Peak Nasal Inspiratory Flow (PNIF), and endoscopic examination.
septoplasty with inferior turbinate reductionActive comparatorProcedure: septoplasty with inferior turbinate reduction.Patients will undergo septoplasty combined with inferior turbinate reduction for correction of symptomatic deviated nasal septum with associated inferior turbinate hypertrophy. Postoperative outcomes will be assessed using NOSE score, Peak Nasal Inspiratory Flow (PNIF), and endoscopic examination.
  • septoplasty (Procedure): Surgical correction of deviated nasal septum to relieve nasal obstruction.
  • septoplasty with inferior turbinate reduction. (Procedure): Surgical correction of deviated nasal septum combined with inferior turbinate reduction to improve nasal airflow and relieve obstruction.

+Outcome measures

Primary outcomes

  • Improvement in nasal obstruction symptoms [Baseline (preoperative), 1 month postoperative, and 3 months postoperative]: Assessment of improvement in nasal obstruction symptoms after surgery using the Nasal Obstruction Symptom Evaluation (NOSE) score.

Secondary outcomes

  • Change in NOSE score [Baseline, 1 month postoperative, and 3 months postoperative]: Comparison of NOSE score changes between patients undergoing septoplasty alone and those undergoing septoplasty with inferior turbinate reduction.
  • Change in Peak Nasal Inspiratory Flow (PNIF) [Baseline, 1 month postoperative, and 3 months postoperative]: Objective assessment of nasal airflow improvement using Peak Nasal Inspiratory Flow measurement.
  • Endoscopic nasal examination findings [Baseline, 1 month postoperative, and 3 months postoperative]: Assessment of postoperative nasal cavity findings by diagnostic nasal endoscopy.

+Eligibility

Sex: All, ages: 18 Years to 50 Years

Inclusion Criteria:

* Patients with symptomatic deviated nasal septum causing persistent nasal obstruction, aged 18-50 years, who failed medical treatment for at least 3 months, will be included in the study.

Exclusion Criteria:

* Patients with previous nasal surgery, nasal polyposis, chronic rhinosinusitis, alar collapse, uncontrolled allergic rhinitis, nasal tumors, or external nasal deformity requiring rhinoplasty will be excluded from the study.

+Publications

  • Fokkens WJ, Lund VJ, Hopkins C, et al. EPOS 2020: European Position Paper on Rhinosinusitis and Nasal Polyps 2020. Rhinology Supplement. 2020.
  • Han JK, Stringer SP, Rosenfeld RM, Archer SM, Baker DP, Brown SM, Edelstein DR, Gray ST, Lian TS, Ross EJ, Seiden AM, Setzen M, Tollefson TT, Ward PD, Welch KC, Wise SK, Nnacheta LC. Clinical Consensus Statement: Septoplasty with or without Inferior Turbinate Reduction. Otolaryngol Head Neck Surg. 2015 Nov;153(5):708-20. doi: 10.1177/0194599815606435. PMID 26527752
  • Stewart MG, Smith TL, Weaver EM, Witsell DL, Yueh B, Hannley MT, Johnson JT. Outcomes after nasal septoplasty: results from the Nasal Obstruction Septoplasty Effectiveness (NOSE) study. Otolaryngol Head Neck Surg. 2004 Mar;130(3):283-90. doi: 10.1016/j.otohns.2003.12.004. PMID 15054368

+Investigators

  • Osama Mohammed Rashad, professor, Principal investigator, Department of otolaryngology, faculty of medicine, sohag university
  • khaled Gamal Dahy, assistant professor, Principal investigator, Department of otolaryngology, faculty of medicine, sohag university