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

NCT07731152 | Not Yet Recruiting

• 1 other identifier: Soh-Med-26-7-3MS
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Deviated Nasal Septum; Nasal Obstruction Septal Deviation Compensatory Inferior Turbinate Hypertrophy

Keywords

septoplasty; deviated nasal septum; nasal obstruction; inferior turbinate hypertrophy; nose score; peak nasal inspiratory flowmeter (PNIF); endoscopic assessment

Outcome Measures

Primary Outcomes (1)

• Improvement in nasal obstruction symptoms

  Assessment of improvement in nasal obstruction symptoms after surgery using the Nasal Obstruction Symptom Evaluation (NOSE) score.

  Baseline (preoperative), 1 month postoperative, and 3 months postoperative

Secondary Outcomes (3)

• Change in NOSE score

  Baseline, 1 month postoperative, and 3 months postoperative

• Change in Peak Nasal Inspiratory Flow (PNIF)

  Baseline, 1 month postoperative, and 3 months postoperative

• Endoscopic nasal examination findings

  Baseline, 1 month postoperative, and 3 months postoperative

Study Arms (2)

septoplasty alone

ACTIVE COMPARATOR

Patients 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.

Procedure: septoplasty

septoplasty with inferior turbinate reduction

ACTIVE COMPARATOR

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.

Procedure: septoplasty with inferior turbinate reduction.

Interventions

septoplasty PROCEDURE

Surgical correction of deviated nasal septum to relieve nasal obstruction.

septoplasty alone

septoplasty with inferior turbinate reduction. PROCEDURE

Surgical correction of deviated nasal septum combined with inferior turbinate reduction to improve nasal airflow and relieve obstruction.

septoplasty with inferior turbinate reduction

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Related Publications (3)

• Fokkens WJ, Lund VJ, Hopkins C, et al. EPOS 2020: European Position Paper on Rhinosinusitis and Nasal Polyps 2020. Rhinology Supplement. 2020.

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Nasal Obstruction

Condition Hierarchy (Ancestors)

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

Study Officials

• Osama Mohammed Rashad, professor

  Department of otolaryngology, faculty of medicine, sohag university

  PRINCIPAL INVESTIGATOR

• khaled Gamal Dahy, assistant professor

  Department of otolaryngology, faculty of medicine, sohag university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mena Mikhael, M.B.B.Ch

CONTACT

01202886850; menamikhael98@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: No masking will be applied. Both participants and investigators will be aware of the surgical intervention performed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mena Mikhael Roshdy

Model Details: Participants will be assigned into two parallel groups: Group A will undergo septoplasty alone, and Group B will undergo septoplasty with inferior turbinate reduction. Postoperative outcomes will be compared between the two groups.

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: July 28, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share