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NCT Number: NCT07434765

Comparison of Outcomes of Conventional Septoplasty vs Conservative Endoscopic Septoplasty

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.

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Key information

Conditions

Deviated Nasal Septum

Age range

16 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shaikh Zayed Hospital, Lahore

Lahore, Punjab Province, 60000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

conventional septoplasty

Procedure

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 septoplasty

Procedure

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

Primary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Shahida Islam Medical Complex

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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