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Not yet recruitingNCT07731152Updated Jul 28, 2026

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

An interventional study of septoplasty and septoplasty with inferior turbinate reduction. in Deviated Nasal Septum and Nasal Obstruction Septal Deviation Compensatory Inferior Turbinate Hypertrophy, sponsored by Sohag University. Not yet recruiting. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-07-28.

Sponsored by Sohag University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

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

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Keywords

  • septoplasty
  • deviated nasal septum
  • nasal obstruction
  • inferior turbinate hypertrophy
  • nose score
  • peak nasal inspiratory flowmeter (PNIF)
  • endoscopic assessment
03

In context

Nasal Obstruction

173 studies on the registry are indexed under Nasal Obstruction; 31 are open to participants now.

This study's planned enrollment of 40 is below the median of 70 across 139 interventional studies indexed under Nasal Obstruction.

Browse Nasal Obstruction studies →

Lead sponsor

Sohag University is the lead sponsor of 1,230 studies on the registry; 636 are open to participants now.

Browse Sohag University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • 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.

    Procedure: septoplasty

  • 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.

    Procedure: septoplasty with inferior turbinate reduction.

Interventions

  • Procedureseptoplasty

    Surgical correction of deviated nasal septum to relieve nasal obstruction.

  • Procedureseptoplasty with inferior turbinate reduction.

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

06

What researchers measure

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.

    Time frame: Baseline (preoperative), 1 month postoperative, and 3 months postoperative

Secondary outcomes

  1. Change in NOSE score

    Comparison of NOSE score changes between patients undergoing septoplasty alone and those undergoing septoplasty with inferior turbinate reduction.

    Time frame: Baseline, 1 month postoperative, and 3 months postoperative

  2. Change in Peak Nasal Inspiratory Flow (PNIF)

    Objective assessment of nasal airflow improvement using Peak Nasal Inspiratory Flow measurement.

    Time frame: Baseline, 1 month postoperative, and 3 months postoperative

  3. Endoscopic nasal examination findings

    Assessment of postoperative nasal cavity findings by diagnostic nasal endoscopy.

    Time frame: Baseline, 1 month postoperative, and 3 months postoperative

07

Study locations

No study locations are listed for this record.

08

References and documents

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 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. PubMed 15054368 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Sep 2027, 12 months later.

Of 39 non-industry interventional studies with no phase under Nasal Obstruction, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 12 months is below that.

Counting every sponsor, half of 60 studies reached it within 18 months; a quarter within 9 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 23, 2026
First posted
Jul 28, 2026
StartEst.
Sep 2026
Primary completionEst.
Sep 2027
CompletionEst.
Sep 2027
Last update
Jul 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07731152
Lead sponsor
Sohag University
Responsible party
Mena Mikhael Roshdy (Mena Mikhael Roshdy, Sohag University) — Principal investigator
First posted
Jul 28, 2026
Start date
Sep 2026 (estimated)
Primary completion
Sep 2027 (estimated)
Completion
Sep 2027 (estimated)
Last update
Jul 28, 2026

Study contacts

Mena Mikhael, M.B.B.Ch
Contact
menamikhael98@gmail.com
01202886850
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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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