Deviated Nasal SeptumNCT07731152
Evaluation of the Outcome of Septoplasty With or Without Inferior Turbinate Reduction
A study testing septoplasty and septoplasty with inferior turbinate reduction. in people with Deviated Nasal Septum and Nasal Obstruction Septal Deviation Compensatory Inferior Turbinate Hypertrophy, run by Sohag University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Deviated Nasal Septum, Nasal Obstruction Septal Deviation Compensatory Inferior Turbinate Hypertrophy
- What is being tested?
- septoplasty and septoplasty with inferior turbinate reduction.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Deviated Nasal Septum, Nasal Obstruction Septal Deviation Compensatory Inferior Turbinate Hypertrophy
- Being tested
- septoplasty, septoplasty with inferior turbinate reduction.
- Keywords
- septoplasty, deviated nasal septum, nasal obstruction, inferior turbinate hypertrophy, nose score, peak nasal inspiratory flowmeter (PNIF), endoscopic assessment
- Medical subject headings
- Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
septoplastyProcedure or surgery
Surgical correction of deviated nasal septum to relieve nasal obstruction.
septoplasty with inferior turbinate reduction.Procedure or surgery
Surgical correction of deviated nasal septum combined with inferior turbinate reduction to improve nasal airflow and relieve obstruction.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: septoplasty with inferior turbinate reduction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in nasal obstruction symptoms
Assessment of improvement in nasal obstruction symptoms after surgery using the Nasal Obstruction Symptom Evaluation (NOSE) score.
Measured: Baseline (preoperative), 1 month postoperative, and 3 months postoperative
Secondary outcomes (3)
Change in NOSE score
Comparison of NOSE score changes between patients undergoing septoplasty alone and those undergoing septoplasty with inferior turbinate reduction.
Measured: Baseline, 1 month postoperative, and 3 months postoperative
Change in Peak Nasal Inspiratory Flow (PNIF)
Objective assessment of nasal airflow improvement using Peak Nasal Inspiratory Flow measurement.
Measured: Baseline, 1 month postoperative, and 3 months postoperative
Endoscopic nasal examination findings
Assessment of postoperative nasal cavity findings by diagnostic nasal endoscopy.
Measured: Baseline, 1 month postoperative, and 3 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Deviated Nasal SeptumStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mena Mikhael Roshdy, Sohag University
- Investigators
- Osama Mohammed Rashad, professor, Principal investigator, Department of otolaryngology, faculty of medicine, sohag universitykhaled Gamal Dahy, assistant professor, Principal investigator, Department of otolaryngology, faculty of medicine, sohag university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07731152
- Sponsor's protocol ID
- Soh-Med-26-7-3MS
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 26527752Stewart 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.
PubMed 15054368
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Outcome of Septoplasty With or Without Inferior Turbinate Reduction
- ClinicalTrials.gov ID
- NCT07731152
- Acronym / sponsor ID
- Soh-Med-26-7-3MS
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 28 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| septoplasty alone | Active comparator | Procedure: 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 reduction | Active comparator | Procedure: 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| septoplastySurgical correction of deviated nasal septum to relieve nasal obstruction. | Procedure or surgery | septoplasty alone |
| septoplasty with inferior turbinate reduction.Surgical correction of deviated nasal septum combined with inferior turbinate reduction to improve nasal airflow and relieve obstruction. | Procedure or surgery | septoplasty with inferior turbinate reduction |
Primary outcome
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.
3 secondary outcomes
Change in NOSE score
Time frame: 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
Endoscopic nasal examination findings
Time frame: Baseline, 1 month postoperative, and 3 months postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- BackgroundFokkens WJ, Lund VJ, Hopkins C, et al. EPOS 2020: European Position Paper on Rhinosinusitis and Nasal Polyps 2020. Rhinology Supplement. 2020.
- Background: PubMed 26527752Han 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.
- Background: PubMed 15054368Stewart 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
Questions about this trial
What is this clinical trial studying?
A study testing septoplasty and septoplasty with inferior turbinate reduction. in people with Deviated Nasal Septum and Nasal Obstruction Septal Deviation Compensatory Inferior Turbinate Hypertrophy, run by Sohag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mena Mikhael, M.B.B.Ch (01202886850, menamikhael98@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in nasal obstruction symptoms (time frame: Baseline (preoperative), 1 month postoperative, and 3 months postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07731152, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.