- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07731152
Evaluation of the Outcome of Septoplasty With or Without Inferior Turbinate Reduction
July 23, 2026 updated by: Mena Mikhael Roshdy, Sohag University
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mena Mikhael, M.B.B.Ch
- Phone Number: 01202886850
- Email: menamikhael98@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: septoplasty alone
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.
|
Surgical correction of deviated nasal septum to relieve nasal obstruction.
|
|
Active Comparator: 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.
|
Surgical correction of deviated nasal septum combined with inferior turbinate reduction to improve nasal airflow and relieve obstruction.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Improvement in nasal obstruction symptoms
Time Frame: 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.
|
Baseline (preoperative), 1 month postoperative, and 3 months postoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in NOSE score
Time Frame: 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.
|
Baseline, 1 month postoperative, and 3 months postoperative
|
|
Change in Peak Nasal Inspiratory Flow (PNIF)
Time Frame: Baseline, 1 month postoperative, and 3 months postoperative
|
Objective assessment of nasal airflow improvement using Peak Nasal Inspiratory Flow measurement.
|
Baseline, 1 month postoperative, and 3 months postoperative
|
|
Endoscopic nasal examination findings
Time Frame: Baseline, 1 month postoperative, and 3 months postoperative
|
Assessment of postoperative nasal cavity findings by diagnostic nasal endoscopy.
|
Baseline, 1 month postoperative, and 3 months postoperative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: 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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
September 1, 2027
Study Registration Dates
First Submitted
July 23, 2026
First Submitted That Met QC Criteria
July 23, 2026
First Posted (Actual)
July 28, 2026
Study Record Updates
Last Update Posted (Actual)
July 28, 2026
Last Update Submitted That Met QC Criteria
July 23, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-Med-26-7-3MS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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