Deviated Nasal SeptumNCT07434765
Comparison of Outcomes of Conventional Septoplasty vs Conservative Endoscopic Septoplasty
A study testing conventional septoplasty and endoscopic septoplasty in people with Deviated Nasal Septum, run by Shahida Islam Medical Complex at 1 site in Pakistan.
Trial summary
OBJECTIVE To compare the outcome of conventional septoplasty and conservative endoscopic septoplasty for symptomatic deviated nasal septum. DATA COLLECTION PROCEDURE This randomized control study will be conducted in the ENT department at Shaikh Zayed Hospital, Lahore, over six months. Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- Deviated Nasal Septum
- What is being tested?
- conventional septoplasty and endoscopic septoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 1 sitePakistan
- Study dates
- 18 Nov 2025to 17 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Individuals with symptomatic deviated nasal septum.
- Patients aged between 16 and 50.
- Patients who show willingness to surgery.
Who cannot join
- Individuals with allergic rhinitis, vasomotor rhinitis, acute infection, and other systemic illnesses.
- Individuals who have undergone other nasal procedure such as turbinectomy.
Trial locations and contacts
1 site in 1 country.
About this study
OBJECTIVE To compare the outcome of conventional septoplasty and conservative endoscopic septoplasty for symptomatic deviated nasal septum.
DATA COLLECTION PROCEDURE This randomized control study will be conducted in the ENT department at Shaikh Zayed Hospital, Lahore, over six months. Ethical approval will be obtained and informed consent forms will be completed by all participants. A sample of 210 cases will be selected using a non-probability consecutive sampling technique, with patients randomized into two groups based on the lottery method: 105 will undergo conventional septoplasty (Group A), and 105 will undergo conservative endoscopic septoplasty (Group B). Detailed patient history and clinical examination will be recorded, and each case will be evaluated subjectively and objectively preoperatively. Nasal septal deviation will be classified based on the side (right, left, or S-shaped) and anatomical involvement (anterior, posterior, or both), with posterior rhinoscopy and diagnostic nasal endoscopy will be performed as needed to rule out other pathologies. For patients in the conventional septoplasty group, the traditional surgical technique for septoplasty will be applied in which bilateral flap elevation will be done. In the conservative endoscopic septoplasty group, an incision will be made 2 mm posterior to the caudal end of the septum (hemitransfixation) on the concave side to access the bony-cartilaginous junction abnormality. The initial mucoperichondrial flap will be elevated. Proper plane elevation will be performed to minimize bleeding, and exposure will be limited to the targeted area.
Read the detailed description
OPERATIONAL DEFINITIONS Conventional Septoplasty: A surgical procedure performed to correct a deviated nasal septum through bilateral mucoperichondrial flap elevation, removal or correction of the deviated septal segment, and repositioning of the septal cartilage and bone to improve nasal airflow. Assessment of outcome will be done through subjective (symptom relief) and objective (endoscopic findings) measures postoperatively.
Conservative Endoscopic Septoplasty: A minimally invasive septal correction technique performed under general anesthesia using a nasal endoscope. The surgeon elevates a single mucoperichondrial flap near the site of maximum deviation, visualizes the area directly, and precisely removes or repositions the deviated portion of the septum while preserving as much normal tissue as possible. Outcomes will be evaluated by comparing symptom improvement and endoscopic findings postoperatively.
Nasal Obstruction: Evaluated subjectively using a patient self-reported improvement scale and objectively by endoscopic assessment of nasal patency at follow-up visits.
Nasal Discharge: Assessed based on the patient's report of reduction or absence of discharge and confirmed through anterior rhinoscopic examination.
Headache: Monitored through patient-reported symptom relief using a standardized pain rating scale during postoperative follow-ups.
Residual Septal Deviation : Residual septal deviation is defined as the persistent deviation of the nasal septum from the midline, as observed after surgical intervention (e.g., septoplasty), and confirmed through endoscopic examination.
Septal Perforation: Septal perforation is defined as a full-thickness defect in the nasal septum-extending through the mucoperichondrium and/or mucoperiosteum and underlying cartilage or bone-creating an abnormal communication between the two nasal cavities. A visible hole or defect in the nasal septum confirmed by anterior rhinoscopy or nasal endoscopy.
Synechiae: Synechiae are defined as abnormal adhesions between the nasal septum and the lateral nasal wall or turbinates, resulting from healing after trauma, surgery, infection, or inflammation, and confirmed by clinical examination via nasal endoscopy Operative Parameters: Operative time from start of surgery till end of surgery in mins and intraoperative blood loss in ml, recorded during surgery.
HYPOTHESIS There is a significant difference between the outcomes of conservative endoscopic septoplasty and conventional septoplasty.
MATERIALS AND METHODS
STUDY DESIGN:
It will be a randomized control study.
SETTING:
The study will be directed at the ENT department, Shaikh Zayed Hospital, Lahore.
SAMPLING TECHNIQUE:
A non-probability consecutive sampling technique will be used.
SAMPLE SIZE:
The sample size of 210 (105 per group) was estimated using 80% power, 95% confidence level, and 88% vs 97% improvement in nasal obstruction (8).
SAMPLE SELECTION
INCLUSION CRITERIA:
- Individuals with symptomatic deviated nasal septum.
- Patients aged between 16 and 50.
- Patients who show willingness to surgery.
EXCLUSION CRITERIA:
- Individuals with allergic rhinitis, vasomotor rhinitis, acute infection, and other systemic illnesses.
- Individuals who have undergone other nasal procedure such as turbinectomy. STATISTICAL ANALYSIS Data will be analyzed in the SPSS V.25. Frequency and percentages will be used to display the qualitative data (such as gender, presence/absence of nasal obstruction, headache, nasal discharge, and septal perforation). The means and standard deviations will be used to display quantitative data (age, operative time, intraoperative blood loss). The independent t-test will be used for quantitative data and the chi-square test for qualitative data for comparing the two groups. A P-value less than 0.05 will be deemed significant. Data will be stratified for age and gender. Post - stratification respective tests of significance will be applied.
- Conditions
- Deviated Nasal Septum
- Being tested
- conventional septoplasty, endoscopic septoplasty
- Keywords
- septoplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional septoplastyProcedure or surgery
For patients in the conventional septoplasty group, the traditional surgical technique for septoplasty will be applied in which bilateral flap elevation will be done. In the conservative endoscopic septoplasty group, an incision will be made 2 mm posterior to the caudal end of the septum (hemitransfixation) on the concave side to access the bony-cartilaginous junction abnormality. The initial mucoperichondrial flap will be elevated. Proper plane elevation will be performed to minimize bleeding, and exposure will be limited to the targeted area. For cases involving subluxated cartilage from the crest, excess cartilage will be carefully trimmed with a No.15 blade Bard-Parker knife without disrupting the vomerochondral junction. Cartilage near the anterior nasal spine will be repositioned over the crest to prevent supra-tip deformity. Any laterally projecting vomerine spur or overlapping cartilage will be resected. In instances of posterior deviation or ethmochondral junction deviation, t
endoscopic septoplastyProcedure or surgery
In the conservative endoscopic septoplasty group, an incision will be made 2 mm posterior to the caudal end of the septum (hemitransfixation) on the concave side to access the bony-cartilaginous junction abnormality. The initial mucoperichondrial flap will be elevated. Proper plane elevation will be performed to minimize bleeding, and exposure will be limited to the targeted area. For cases involving subluxated cartilage from the crest, excess cartilage will be carefully trimmed with a No.15 blade Bard-Parker knife without disrupting the vomerochondral junction. Cartilage near the anterior nasal spine will be repositioned over the crest to prevent supra-tip deformity. Any laterally projecting vomerine spur or overlapping cartilage will be resected. In instances of posterior deviation or ethmochondral junction deviation, the bony septum will be fractured for midline alignment or minimally resected at the ethmoidal plate's caudal end. A 'C' shaped deviation will be corrected through prec
| Study group | Role | What they receive |
|---|---|---|
| Conventional septoplasty | Placebo comparator | Not described Receives: Procedure: conventional septoplasty |
| endoscopic septoplasty | Experimental | Not described Receives: Procedure: endoscopic septoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Residual Septal Deviation
Residual septal deviation is defined as the persistent deviation of the nasal septum from the midline, as observed after surgical intervention (e.g., septoplasty), and confirmed through endoscopic examination
Measured: 3 weeks
Rate of Septal Perforation
Septal perforation is defined as a full-thickness defect in the nasal septum-extending through the mucoperichondrium and/or mucoperiosteum and underlying cartilage or bone-creating an abnormal communication between the two nasal cavities. A visible hole or defect in the nasal septum confirmed by anterior rhinoscopy or nasal endoscopy
Measured: 1 week
Rate of Synechiae
Synechiae are defined as abnormal adhesions between the nasal septum and the lateral nasal wall or turbinates, resulting from healing after trauma, surgery, infection, or inflammation, and confirmed by clinical examination via nasal endoscopy
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start18 Nov 2025
- Primary completion17 Jan 2026
- Study completion17 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deviated Nasal SeptumStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahida Islam Medical Complex
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Mudassar Saeed Pansota, Shahida Islam Medical Complex
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07434765
- Sponsor's protocol ID
- Sheikh Zayed Hospital Lahore
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Outcomes of Conventional Septoplasty vs Conservative Endoscopic Septoplasty
- ClinicalTrials.gov ID
- NCT07434765
- Acronym / sponsor ID
- Sheikh Zayed Hospital Lahore
- Conditions
- Deviated Nasal Septum
- Keywords
- septoplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Shahida Islam Medical ComplexUniversity, hospital or other
- Study start
- 18 Nov 2025 (actual)
- Primary completion
- 17 Jan 2026 (actual)
- Study completion
- 17 Jan 2026 (actual)
- First posted
- 27 Feb 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.
OBJECTIVE To compare the outcome of conventional septoplasty and conservative endoscopic septoplasty for symptomatic deviated nasal septum.
DATA COLLECTION PROCEDURE This randomized control study will be conducted in the ENT department at Shaikh Zayed Hospital, Lahore, over six months. Ethical approval will be obtained and informed consent forms will be completed by all participants. A sample of 210 cases will be selected using a non-probability consecutive sampling technique, with patients randomized into two groups based on the lottery method: 105 will undergo conventional septoplasty (Group A), and 105 will undergo conservative endoscopic septoplasty (Group B). Detailed patient history and clinical examination will be recorded, and each case will be evaluated subjectively and objectively preoperatively. Nasal septal deviation will be classified based on the side (right, left, or S-shaped) and anatomical involvement (anterior, posterior, or both), with posterior rhinoscopy and diagnostic nasal endoscopy will be performed as needed to rule out other pathologies. For patients in the conventional septoplasty group, the traditional surgical technique for septoplasty will be applied in which bilateral flap elevation will be done. In the conservative endoscopic septoplasty group, an incision will be made 2 mm posterior to the caudal end of the septum (hemitransfixation) on the concave side to access the bony-cartilaginous junction abnormality. The initial mucoperichondrial flap will be elevated. Proper plane elevation will be performed to minimize bleeding, and exposure will be limited to the targeted area.
Detailed description
OPERATIONAL DEFINITIONS Conventional Septoplasty: A surgical procedure performed to correct a deviated nasal septum through bilateral mucoperichondrial flap elevation, removal or correction of the deviated septal segment, and repositioning of the septal cartilage and bone to improve nasal airflow. Assessment of outcome will be done through subjective (symptom relief) and objective (endoscopic findings) measures postoperatively.
Conservative Endoscopic Septoplasty: A minimally invasive septal correction technique performed under general anesthesia using a nasal endoscope. The surgeon elevates a single mucoperichondrial flap near the site of maximum deviation, visualizes the area directly, and precisely removes or repositions the deviated portion of the septum while preserving as much normal tissue as possible. Outcomes will be evaluated by comparing symptom improvement and endoscopic findings postoperatively.
Nasal Obstruction: Evaluated subjectively using a patient self-reported improvement scale and objectively by endoscopic assessment of nasal patency at follow-up visits.
Nasal Discharge: Assessed based on the patient's report of reduction or absence of discharge and confirmed through anterior rhinoscopic examination.
Headache: Monitored through patient-reported symptom relief using a standardized pain rating scale during postoperative follow-ups.
Residual Septal Deviation : Residual septal deviation is defined as the persistent deviation of the nasal septum from the midline, as observed after surgical intervention (e.g., septoplasty), and confirmed through endoscopic examination.
Septal Perforation: Septal perforation is defined as a full-thickness defect in the nasal septum-extending through the mucoperichondrium and/or mucoperiosteum and underlying cartilage or bone-creating an abnormal communication between the two nasal cavities. A visible hole or defect in the nasal septum confirmed by anterior rhinoscopy or nasal endoscopy.
Synechiae: Synechiae are defined as abnormal adhesions between the nasal septum and the lateral nasal wall or turbinates, resulting from healing after trauma, surgery, infection, or inflammation, and confirmed by clinical examination via nasal endoscopy Operative Parameters: Operative time from start of surgery till end of surgery in mins and intraoperative blood loss in ml, recorded during surgery.
HYPOTHESIS There is a significant difference between the outcomes of conservative endoscopic septoplasty and conventional septoplasty.
MATERIALS AND METHODS
STUDY DESIGN:
It will be a randomized control study.
SETTING:
The study will be directed at the ENT department, Shaikh Zayed Hospital, Lahore.
SAMPLING TECHNIQUE:
A non-probability consecutive sampling technique will be used.
SAMPLE SIZE:
The sample size of 210 (105 per group) was estimated using 80% power, 95% confidence level, and 88% vs 97% improvement in nasal obstruction (8).
SAMPLE SELECTION
INCLUSION CRITERIA:
- Individuals with symptomatic deviated nasal septum.
- Patients aged between 16 and 50.
- Patients who show willingness to surgery.
EXCLUSION CRITERIA:
- Individuals with allergic rhinitis, vasomotor rhinitis, acute infection, and other systemic illnesses.
- Individuals who have undergone other nasal procedure such as turbinectomy. STATISTICAL ANALYSIS Data will be analyzed in the SPSS V.25. Frequency and percentages will be used to display the qualitative data (such as gender, presence/absence of nasal obstruction, headache, nasal discharge, and septal perforation). The means and standard deviations will be used to display quantitative data (age, operative time, intraoperative blood loss). The independent t-test will be used for quantitative data and the chi-square test for qualitative data for comparing the two groups. A P-value less than 0.05 will be deemed significant. Data will be stratified for age and gender. Post - stratification respective tests of significance will be applied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional septoplasty | Placebo comparator | Procedure: conventional septoplasty |
| endoscopic septoplasty | Experimental | Procedure: endoscopic septoplasty |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Individuals with symptomatic deviated nasal septum.
- Patients aged between 16 and 50.
- Patients who show willingness to surgery.
Key exclusion criteria (2 listed)
- Individuals with allergic rhinitis, vasomotor rhinitis, acute infection, and other systemic illnesses.
- Individuals who have undergone other nasal procedure such as turbinectomy.
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 |
|---|---|---|
| conventional septoplastyFor patients in the conventional septoplasty group, the traditional surgical technique for septoplasty will be applied in which bilateral flap elevation will be done. In the conservative endoscopic septoplasty group, an incision will be made 2 mm posterior to the caudal end of the septum (hemitransfixation) on the concave side to access the bony-cartilaginous junction abnormality. The initial mucoperichondrial flap will be elevated. Proper plane elevation will be performed to minimize bleeding, and exposure will be limited to the targeted area. For cases involving subluxated cartilage from the crest, excess cartilage will be carefully trimmed with a No.15 blade Bard-Parker knife without disrupting the vomerochondral junction. Cartilage near the anterior nasal spine will be repositioned over the crest to prevent supra-tip deformity. Any laterally projecting vomerine spur or overlapping cartilage will be resected. In instances of posterior deviation or ethmochondral junction deviation, t | Procedure or surgery | Conventional septoplasty |
| endoscopic septoplastyIn the conservative endoscopic septoplasty group, an incision will be made 2 mm posterior to the caudal end of the septum (hemitransfixation) on the concave side to access the bony-cartilaginous junction abnormality. The initial mucoperichondrial flap will be elevated. Proper plane elevation will be performed to minimize bleeding, and exposure will be limited to the targeted area. For cases involving subluxated cartilage from the crest, excess cartilage will be carefully trimmed with a No.15 blade Bard-Parker knife without disrupting the vomerochondral junction. Cartilage near the anterior nasal spine will be repositioned over the crest to prevent supra-tip deformity. Any laterally projecting vomerine spur or overlapping cartilage will be resected. In instances of posterior deviation or ethmochondral junction deviation, the bony septum will be fractured for midline alignment or minimally resected at the ethmoidal plate's caudal end. A 'C' shaped deviation will be corrected through prec | Procedure or surgery | endoscopic septoplasty |
Primary outcome
Rate of Residual Septal Deviation
Time frame: 3 weeks
Residual septal deviation is defined as the persistent deviation of the nasal septum from the midline, as observed after surgical intervention (e.g., septoplasty), and confirmed through endoscopic examination
Rate of Septal Perforation
Time frame: 1 week
Septal perforation is defined as a full-thickness defect in the nasal septum-extending through the mucoperichondrium and/or mucoperiosteum and underlying cartilage or bone-creating an abnormal communication between the two nasal cavities. A visible hole or defect in the nasal septum confirmed by anterior rhinoscopy or nasal endoscopy
Rate of Synechiae
Time frame: 3 weeks
Synechiae are defined as abnormal adhesions between the nasal septum and the lateral nasal wall or turbinates, resulting from healing after trauma, surgery, infection, or inflammation, and confirmed by clinical examination via nasal endoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional septoplasty and endoscopic septoplasty in people with Deviated Nasal Septum, run by Shahida Islam Medical Complex at 1 site in Pakistan.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Residual Septal Deviation (time frame: 3 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Feb 2026.